Clinical information tends to be more complex, comes from multiple sources in different formats. As a result, clinical data submission has become time-consuming, costly and error-prone. CDISC® (Clinical Data Interchange Standards Consortium) established new data standards to speed up data-review and improve clinical data exchange, storage and archival. Our technology edge combined to our experience in standards implementation allows us to develop tailored CDISC solutions to accelerate your FDA review. Clinovo introduced a new opportunity to learn these recognized clinical data standards!
Clinovo’s new “CDISC Standards: Theory and Application” class is an 8-week training program starting in June 11th, 2013. The TechTrainings are technical hands-on classes for entry-level or experienced clinical trial professionals designed to help them reach the next step in their professional career. The class will be held in Palo Alto at Dentons Offices or remotely.
Taught by Sy Truong, President at Meta-Xceed and author of award-winning papers, this new course will give an overview of CDISC standards: ODM, SDTM, ADaM and Define.XML. Students will learn how to transform legacy data into these clinical standards through real-life examples. Case studies will include data exchange, archival, and electronic submission to regulatory agencies such as the FDA.
Clinovo will continue to offer the “Base Clinical SAS Programming” class to help entry-level programmers prepare the Base SAS certification, as well as the “Advanced Clinical SAS Programming” class to tackle advanced real-world SAS programming challenges. Clinovo offers $50 gift cards for referrals.
More information on the class can be found on clinovo.com/techtrainings.
Olivier Roth launched the TechTrainings by Clinovo in 2012, a series of hands-on courses for clinical trial professionals, leveraging his company’s years of on-field experience and industry expertise. He is the Marketing & Communication Coordinator at Clinovo, a CRO based in Sunnyvale, focused on streamlining clinical trials for life science companies through technology solutions. Olivier helps managing Clinovo’s marketing and communication from marketing strategy to partnership management, lead generation, event planning and new business opportunities. Prior to Clinovo, Olivier was working as a Strategic Marketing Consultant at VivaSante, an international consumer healthcare company based in Paris.
This infographic is a visual and appealing way to understand why open-source Electronic Data Capture (EDC) is an alternative of choice to proprietary systems or paper-based studies. Do you own a website, a forum or a blog on clinical trials or Electronic Data Capture (EDC) ? You are invited to share this infographic with your readers! How? Simply copy this code to your page: <a href=”http://blog.clinovo.com/new-infographic-why-choose-open-source-edc/”><img alt=”Infographic: Why choose open-source EDC?” choose=”open-source=” src=”http://blog.clinovo.com/wp-content/uploads/2013/05/infographic-2-resized.png” style=”height: 1817px; width: 675px;” why=”" /></a>[Source: <a href="http://blog.clinovo.com" title="Infographic: Why choose open-source EDC?">eClinical Trends by Clinovo</a>]
Clinical research is one of the most expensive areas of drug development. Bringing an approved new drug from initial private investment to a patient takes over 13 years and $1.3 billion, or an average of $146 million per year.1
Industry data shows clinical trials costs are growing across all development phases. A 2011 report, Clinical Operations: Benchmarking Per-Patient Costs, Staffing and Adaptive Design by Cutting Edge Information, tracked costs for 100 trials across multiple therapeutic areas finding that per-patient clinical trial costs rose an average 70% from 2008 to 2011.2 The largest increases occurred in Phase IIIa and Phase IIIb. Phase I trials are also suffering from cost inflation, with per-patient costs increasing by an average 46% over the same time period.3
Electronic Data Capture (EDC), which collects clinical trial data electronically rather than on paper, is becoming an increasingly popular solution for streamlining data processing. This white paper will review benefits that EDC brings, extending beyond, and contributing to, cost-efficiency. It will also discuss challenges and limitations that sponsor companies can expect when implementing EDC solutions in clinical research.
Key benefits of Electronic Data Capture
1. Cost-saving: Forrester Research analyzed cost-savings to Novartis, which has utilized a customized open-source EDC system for over 400 clinical trials. For a 12-month Phase II clinical trial with 20 sites and 10 patients per site, the operational savings were substantial: $347,600.4
Figure 1. Forrester Research Paper versus EDC cost comparison.5
The cost of the clinical trial was reduced from $732,000 to $384,000 thanks to remote monitoring, fewer site visits, shorter patient recruitment times, reduction (or elimination) of printing costs, faster data entry, and lower data cleaning costs.6 Visit-related costs were reduced by 50%, data cleaning costs by 80%, and all other operational expenses by 32%.7
Overall, Novartis claimed a savings of approximately $17 million by no longer needing to print CRFs on NCR paper, a necessity in paper-based trials, which represented $42,500 per Novartis study analyzed.8 If we consider that printing costs run as high as $100 per casebook, a study with 500 patients would cost up to an estimated $50,000 prior to factoring in staffing costs for casebook preparation, without accounting for shipping.
2. Time-saving: Single data entry—which replaces the completion of paper CRFs followed by double data entry—remote monitoring, and reduction in the number of queries each save a considerable amount of time. Overall, they have been calculated to reduce the duration of clinical development by up to 30%.9
It is critical to note that the most significant time-savings occur during database lock. It has been shown that, when it is time for database lock, there is less missing data and fewer errors and queries with EDC than with paper-based systems. As shown in the table below, database lock can take as long as nine days with paper, whereas database lock is performed in only one day with an EDC system.
Figure 2. Time savings.
3. Cleaner data and reduced queries: EDC adoption leads to a dramatic reduction in the types of data errors found in paper-based CRF studies, such as out-of-range values and missing data. In addition, errors can be detected and corrected much earlier in the clinical trial with EDC than with paper-based systems that can only rely on ad hoc mid-study analysis. EDC edit checks are automatic and visible at the time of entry and are therefore resolved immediately, resulting in cleaner data at time of entry in database.
A case study led by Applied Clinical Trials compared a paper query management system with an EDC system using edit checks and found a 65% reduction in the number of queries.10
Figure 3. Reduction of the number of queries.11
4. Traceability: Title 21 Code of Federal Regulations Part 11 (21 CFR Part 11) is the United States Federal Regulation which applies to electronic records and electronic signatures in clinical systems.12 EDC systems must track all data changes in audit trails in order to be 21 CFR Part 11 compliant. Vendors must also plan for disaster recovery and analyze and remedy potential risks. It is critical to note that answering FDA reviewers’ questions is made easier by EDC systems as they can track any changes automatically.
5. Simplified monitoring: Remote monitoring enabled by EDC systems drastically lowers the cost of monitor visits. EDC enables early identification of discrepancies or data entry errors, minimizing the time spent by monitors at sites. Estimating that a visit can cost up to $3,000, the total savings for a study with 20 sites can reach $60,000.
6. Reduced data entry: With paper-based systems, clinical data must first be written on paper and then double-data entered into a central system, which is a time-consuming and error-prone process. Electronic Data Capture’s Impact on Late Phase Research by Dr. Hugh P. Levaux claims that, when considering manual double-data entry costs can be as high as $3 per page, a 100-page casebook can cost as much as $300. These figures translate to a cost of $150,000 for a 500-patient study.13 EDC applications necessitate only single-data entry since data entry occurs directly at the site and is the equivalent of CRF completion on paper.
7. Reactivity: Some EDC systems provide real-time alerts and reports, giving decision makers instant access to critical data. ClinCapture by Clinovo recently introduced LiveReportsTM to provide a real-time overview of the clinical trial. Real-time reports enable decision makers to be more proactive in identifying bottlenecks such as late sites, and to be more reactive to data to ensure patient safety.
Ultimately, EDC systems enable sponsors to make efficacy and/or safety determinations earlier in the drug development process. EDC enables pharmaceutical, biotechnology, and medical device industries to focus on the development of the best drug, biologic, or device candidates that will most benefit patients, saving time and millions of dollars in drug development.
8. Reusability: A characteristic of EDC is the ability to reuse the system in future studies which lowers the cost of EDC adoption in the long run. Once forms and their associated edit checks are created, they can be stored in a library and reused for an infinite number of studies. In a case study from Clinovo, a leading global technology medical device company was looking to efficiently manage large amounts of data while staying on-time and on-budget.14 Clinovo trained the sponsor’s staff to build its studies on the open-source EDC system ClinCapture, enabling the sponsor to customize the ClinCapture platform and roll out nine additional studies themselves. In addition, the sponsor was able to host the system in-house, thereby avoiding vendor lock-in and retaining full control over their clinical data.
9. Mid-study changes: EDC systems make mid-study changes such as the addition of new fields in a Case Report Form (CRF) much smoother than do paper-based studies. Some EDC systems support CRF versioning to automatically update all CRFs in selected sites in just a few seconds.
10. Patient Safety: Improved data quality, better reactivity, and reduction in study time themselves contribute to the faster delivery of better medications. Some specific EDC features have an even bigger impact: faster notification of adverse events, for example, can help with earlier and better decision-making, potentially saving hundreds or thousands of patients from exposure to unsafe medication.
Limits and difficulties of EDC adoption
Despite the tangible benefits of Electronic Data Capture, the adoption of EDC systems has remained slow in some segments of clinical research. Only 40% of Phase I clinical trials had adopted EDC by the end of 2012.
Clinical trial experts suggest this slow adoption is explained by the high cost of proprietary EDC systems and by the structural changes and learning curves incurred by sponsor companies when implementing an EDC system. Some attribute low adoption rates to negative impressions of early EDC systems based on poor design and limited performance.
There is a common perception that paper-based studies are faster and less expensive to implement than are EDC studies. It is undoubtedly true that studies can be started faster on paper. But data shows that their overall duration is as much as 30% longer on average.15
EDC vendors are making an effort to minimize the study-build time by leveraging reusability and automation. It is now possible to deploy a full EDC study in days rather than the weeks or months historically, assuming study form reusability.
The initial cost of EDC is also a major determent to its adoption, especially for preclinical or Phase I trials with lower budgets. The most significant costs are incurred when hiring vendor(s), assigning clinical and data management experts to interface with programmers, and setting up internal computer systems, including the purchase of hardware and software. Following these initial setup phases, subsequent study costs for each new clinical trial can become marginal, leaving mostly fixed annual fees for system maintenance, including optional hosting fees.
Finally, data privacy and security is also a major concern among trial investigators. A study by Silico Research shows that investigators cite security and confidentiality as key concerns when conducting EDC-based clinical trials.16 It is essential to select EDC vendors who thoroughly follow regulations and offer secure hosting services with data redundancy ensuring full disaster recovery.
Figure 4. Trial investigators concerns on EDC-based clinical trials.17
Among other concerns, sponsors also worry about the steep learning curve and heavy training needed to switch to an EDC system. The implementation of an EDC system drastically changes the structure and the processes within a sponsor organization. EDC vendors are aware of these difficulties and are focusing on improving EDC systems’ ease-of-use. Vendors are also putting an emphasis on training sessions for end users as well as on ensuring reactive support services.
Moreover, one can observe standardization in the user interface guided by consensus-based collaborative standards like CDISC/CDASH, allowing for consistent user experience across vendors and studies and thereby requiring less training to adapt to new study screens.
Conclusion: Planning EDC deployment, a key success factor
A potential steep learning curve for clinical research teams, structural changes in organizations, and perceived high cost of EDC implementation are some of the legitimate reasons to hesitate before adopting EDC. However, considerable time- and cost-savings, along with drastic data quality improvement outweigh these difficulties.
It is necessary for sponsors to put controls in place to ensure data quality and integrity throughout their clinical trials. This can and is done with paper-based clinical studies, but often with unintended negative consequences, including delay and looping in the data entry process. With EDC, edit checks are integrated from the start and are seamlessly activated during data entry, ensuring that the sites, which are responsible for providing study data, can address most issues on the spot.
In order to fully benefit from EDC systems, it is critical for sponsors to plan ahead. Most importantly, planning must be carried out prior to study build. Data entry screens, online edit check specifications, and the annotated case report form (aCRF) must be implemented before the study goes live.
Though the process changes as it evolves, Electronic Data Capture brings complete and up-front integration of the trial design and setup to the different operational groups involved, including Clinical Operations, Clinical Data Management, and Biostatistics, thus ensuring not only that the data entry process is easy and well-customized for the clinical sites, but also that the final database exports will be fully compliant and meet analysis requirements.
Olivier Roth, Marketing and Communication Coordinator, Clinovo
- Herper, M. The Truly Staggering Cost of Inventing New Drugs. Forbes website. http://www.forbes.com/sites/matthewherper/2012/02/10/the-truly-staggering-cost-of-inventing-new-drugs/. February 2012. Accessed April 9, 2013.
- Per-Patient Clinical Trial Costs Rise 70% in Three Years. Cutting Edge Information website. http://www.cuttingedgeinfo.com/2011/per-patient-clinical-trial-costs/. July 2011. Accessed April 8, 2013.
- Peachey J, Spink C, Fraser H, Henderson S. The eClinical equation: Part 1: Electronic Data Capture. IBM Global Business Services: IBM Institute for Business Value. 2005; 3. http://www-05.ibm.com/de/healthcare/literature/eclinical-equation-1-lang.pdf. Accessed April 8, 2013.
- Ibid, 3-4.
- Green, J. Realising the value proposition of EDC. Innovations in Clinical Trials. September 2003; 13. http://www.iptonline.com/articles/public/ICTTWO12NoPrint.pdf. Accessed April 8, 2013.
- Mitchel J, You J, Lau A, Kim Y. Paper vs. Web: A Tale of Three Trials. Applied Clinical Trials: Internet Insight Section. August 2001; 1. http://www.medchannels.com/pdfs/whitepapers/ACTArticle.pdf. Accessed April 8, 2013.
- Part 11, Electronic Records; Electronic Signatures – Scope and Application. U.S. Food and Drug Administration website. http://www.fda.gov/regulatoryinformation/guidances/ucm125067.htm. March 23, 2009. Accessed April 9, 2013.
- Levaux, H. Electronic Data Capture’s Impact on Late Phase Research. Business Briefing: Pharmatech. 2004. http://www.touchbriefings.com/pdf/890/PT04_Ninaza.pdf. Accessed April 8, 2013.
- Clinovo Case Study: Open Source EDC Unmatched Cost-efficiency. Clinovo website. August 28, 2012. http://www.clinovo.com/userfiles/clinovo-open-source-edc-unmatched-cost-efficiency.pdf. Accessed April 8, 2013.
- Green, J. Realising the value proposition of EDC. Innovations in Clinical Trials. September 2003; 13. http://www.iptonline.com/articles/public/ICTTWO12NoPrint.pdf. Accessed April 8, 2013.
- Peachey J, et al. The eClinical equation: Part 1: Electronic Data Capture. IBM Global Business Services: IBM Institute for Business Value. 2005; 9. http://www-05.ibm.com/de/healthcare/literature/eclinical-equation-1-lang.pdf. Accessed April 8, 2013.
Thank you Note
- Jean Maupas, Director of Operations, Clinovo
- Dave Alderson, Senior Director of Sales, Clinovo
- Anil Kishan, Marketing Assistant, Clinovo
- Maxwell Love, Business Development, Clinovo
Clinovo releases its open-source community for users of ClinCapture® and developers around the world to collaborate on the enhancement of its open-source Electronic Data Capture (EDC) system.
ClinCapture’s® open-source community brings users and developers together to constantly enhance the EDC system and better meet the needs of life science companies. ClinCapture® is the most advanced open-source Electronic Data Capture (EDC) system. It is tailored to meet the needs of life science companies looking to run cost-effective phase I to IV clinical trials, investigator and registry studies.
“I strongly believe open-source is the future of clinical trials”, explains Marc Desgrousilliers, CTO at Clinovo. Clinovo envisions to develop new top-of-the-edge features, increase ClinCapture’s® performance and bring user experience to the next level.” Users and developers’ involvement in ClinCapture’s® community will ultimately help deliver medical innovations faster to patients”.
Electronic Data Capture (EDC) developers can download ClinCapture® on clinovo.com/clincapture/community and start contributing their code. Clinical Data Managers, Site Monitors, Clinical Research Associates and Clinical Research Coordinators can submit their requirements and feedback, which will be added to the product roadmap, by posting their ideas on the new forum at clinovo.com/clincapture/forum.
Tom Hickerson, Senior EDC Manager at Clinovo and first open-source EDC expert, gave an interview on his 10 years of experience with open-source Electronic Data Capture (EDC). He explains the benefits of open-source EDC, describes the new feature enhancements added to ClinCapture®, and details the product roadmap for 2013. “We are looking at an ambitious roadmap for 2013, including a series of focused releases, in which community members will play an instrumental role”.
On average, bringing an approved new drug from initial private investment to a patient takes over 13 years and $1.9 billion, or an average of $146 million per year. In this context, ClinCapture’s® cost/benefit comparison makes it a solution of choice for sponsors looking to run cost-effective early phases clinical trials, investigator, post-marketing or registry studies.
ClinCapture® was launched by Clinovo in 2009. Electronic Data Capture has been a critical area of growth for Clinovo in the past years. Thirty studies are currently running on ClinCapture®, including pharma, biotech and medical device studies. ClinCapture® has been repeatedly chosen for its cost-efficiency, flexibility and advanced customization. Client case studies are available on clinovo.com/resource-center/case-studies.
ClinCapture® is an advanced and flexible open-source electronic data capture (EDC) platform designed to streamline clinical trials. As an open-source EDC solution, ClinCapture® is tailored to meet the needs of life science companies looking to run cost-effective clinical trials. Clinovo released a new stable version of ClinCapture® in January 2013. Clinovo introduced a series of advanced features to streamline data capture and improve clinical data quality and integrity, including new LiveReports for real-time monitoring. The release featured a more intuitive navigation, rationalized roles, and one-click access function to many of the routine functions like scheduling events and data entry.
Clinovo partners with life science companies to streamline their clinical trials, leveraging years of expertise in systems integration, open-source technology and industry standards. Clinovo provides Staffing Solutions, eClinical Systems and Biometrics Services including Clinical Data Management, Electronic Data Capture, CDISC mapping, SAS Programming and technical trainings.
Sophie McCallum, Marketing Manager
2012 was a good year for the life science industry, with a 7% growth in R&D pipelines and 35 new drugs approved by the FDA, delivering some truly innovative, needed therapies. Challenges faced include the feared patent cliff as well as passing of the medical device tax set forward in 2010.
This year, the FDA approved 35 new drugs during the fiscal year, which ran from October 1, 2011 to September 30, 2012. The approval rate in 2012 matched that of 2011, both reaching higher rates than previously seen.
Many of these new drugs are successfully going through the review process as they are addressing unmet needs for deadly diseases. Additionally, the FDA met their deadlines 34 of 35 times, surpassing their PDUFA goal of 90%. Since the close of the fiscal year, no less than 3 new drugs have already been approved.
However, the Sequester may affect the FDA approval rates and goals. The Sequester, passed in August 2011 as part of the Budget Control Act (BCA), is a package of automatic spending cuts projected to total $1.2 trillion, scheduled to begin in 2013 and end in 2021. Part of these automatic spending cuts will be geared towards FDA budgets, which could be forced to slash jobs and thus lose some of its capacity to approve drugs for 2013.
On the basis of third-quarter earnings, Ernst & Young estimates combined sales at the global top 13 drug companies dropped by close to 4% this year from about $557 billion in 2011.
With the patent cliff taking its toll on some of the best selling drugs ever known to our industry, the biggest blockbuster of 2012 is Humira from Abbott Laboratories, totaling $9.48B. Initially approved for the treatment of rheumatoid arthritis, the money maker is drawing on the expanded treatment of 5 additional indications. In total, the top 15 selling drugs generated $95.55B in revenue (and counting).
In addition, 6 companies found themselves in the Top 10 most charitable organizations over the last year. Taking the top spot was Pfizer with over $3.06B in cash and products donated. Merck (#3), Abbott Laboratories (#7), Johnson & Johnson (#8), Eliy Lilly (#9), and Bristol Meyers Squibb (#10) round out the list with all 6 companies donations totaling $6.9B.
The Patent Cliff
The patent cliff has taken a large effect this year, and by 2015 will have an estimated $250B in lost sales for the industry. The once mighty Lipitor has fallen from the top spot to number 10 this year, with a 42% sales drop in the first quarter of 2012. Four other best-sellers lost patent protection this year as well, affecting $22.8B worth of retail sales for 2012.
Capital Market and Merger And Acquisitions (M&As)
As of the third quarter 2012, 14 U.S. life sciences companies completed IPOs, raising almost $950 million. Twelve of the 14 U.S. companies are in drug discovery and development, and California companies account for half of the IPOs in 2012.
The $146B M&A market this year found some much watched participants, including the acquisition of Human Genome Sciences by GlaxoSmithKline. However, overall M&A fell by 35% in 2012, down $79B from last year. According to the 2013 Baybio 2013 California Biomedical annual report, As of November 2012, 53 M&A transactions were recorded of California companies of which 33 were biopharmaceutical, 18 diagnostics and two R&D companies. The top M&A deal was the acquisition of Amylin Pharmaceuticals for $10.6 billion by Bristol-Myers Squibb in collaboration with AstraZeneca.
According to sources, multi-billion-dollar acquisitions were outnumbered by more modest research pacts and partnerships in which drug companies acted to add promising compounds to their pipelines. The early weeks of 2012 brought a flurry of research pacts focused on oncology, typical of a more targeted approach. Takeda Pharmaceuticals, Merck & Co., Eli Lilly & Co., and AstraZeneca all gained access to compounds that biotech firms were developing for cancer.
Overall, U.S. life sciences (biotechnology and medical devices) investment for the first three quarters of 2012 is down 19 percent in dollars and 12 percent in deals from the same time period in 2011.
Investments in emerging markets increased by 65% this year, reaching a total of $20B, with China as leader of the pack. While the US will remain the largest market, China’s growth of 14 – 18% over the next 2 years will give it a firm place at #2.
Market presence is expanding to developing countries due to the need for higher medical demand, use of generics, and growing populations. Latin America, North Africa, and other parts of Asia are seeing increased attention from the industry while Brazil, Russia, India and China (BRIC) continue to grow.
Biggest Marketing Settlements
2012 saw 4 of the largest marketing settlements ever handed out to pharma. Not only did it see 4, but they ranked among the first 7, including the #1 spot, totaling $6.462B. The winners, or losers in this case, are GlaxoSmithKline ($3B), Abbott ($1.5B), Johnson & Johnson ($1.2B), and Amgen ($762M). All of the settlements shared a common thread of unlawful promotion with a few having kickbacks as reasons for judgment. The increase in penalties can be related to the Justice Departments continued outrage for misbehaving, going so far as suggest future penalties be given to executives for irresponsible corporate behavior or taking away patent rights.
This year also saw the banning of pay-for-delay deals, where brand name drug companies made deals for their generic competitors to delay the release of the competition. The Federal Trade Commission led this mission as these delays cost taxpayers $3.5B a year in higher drug prices, as well as violating trade laws.
Medical Device Tax
Effective January 1st, 2013, the Medical Device Excise Tax went into effect, generating an expected $29B in revenue over the next 10 years. Part of a 2010 healthcare law, 2012 saw the attempt, and fail, for repeal and has since become finalized by the IRS. The tax, applied to most tools used by medical professionals (including those used for humanitarian efforts), has garnered much criticism with some reflecting that the tax will prevent researchers from innovation, ultimately costing lives for patients who need these tools. As the tax will apply to all companies, regardless of profit, companies have to navigate the new arena for funding, R&D, and expansion. Some companies who will be hit hardest, such as Stryker, have already started reducing costs by reducing work force.
How the medical device tax will affect the industry remains to be seen, as well as the patent cliff. 2013 is projected to be another year of growth with a strong pipeline of potential new blockbusters under development. Will big companies look to acquisition as a way of bolstering their offerings? Will the rising stars, such as Onyx, be purchased by the industry giants? Will Alzheimer’s treatments catch a break? Only time will tell what the future holds.
- “Life Science Trends 2012”, Alexander, D., McMerty, B., Frey, K., Waddell, A., Carlyle & Conlan, 2012
- “FY 2012 Innovative Drug Approvals”, U.S. Food and Drug Administration, December 2012
- “Pharma R&D Annual Review 2012”, Llyod, I., citeline, 2012
- “The 15 Most Generous Companies Of The Past Year”, Sprung, S., Business Insider, July 26, 2012
- “The Best Drug Companies Of The Past 15 Years”, Herper, M., Forbes, February 9, 2012
- “Startups struggle with impending device tax”, Garde, D., www.fiercemedicaldevices.com, November 2, 2012
- “These are the top 10 payers of the medical device tax, says Moody’s”, Parmar, A., Med City News, March 8, 2012
- “Pharma’s Top 11 Marketing Settlements”, Staton, T., Palmer, E., www.fiercemedicaldevices.com, June 26, 2012
- “Beyond the Patent Cliff”, By Rick Mullin, December 10, 2012. http://cen.acs.org/articles/90/i50/Beyond-Patent-Cliff.html
- “The Sequester, explained”, By Suzy Khimm, September 14, 2012. http://www.washingtonpost.com/blogs/wonkblog/wp/2012/09/14/the-sequester-explained/
- “California Biomedical Industry 2013 Report”, By BayBio, CHI and PWC, January 7, 2013. www.CaliforniaBiomedReport.com
- “A Banner Year for New Drugs”, The 2012 Burill Report, http://www.burrillreport.com/article-a_banner_year_for_new_drugs.html
- “Big pharmas eyeing innovative targets”, October 25, 2012. http://www.acquisitionsdaily.com/2012/10/25/big-pharmas-eyeing-innovative-targets/
Marketing Manager at Clinovo
Associate, Business Development
Extract from the 2013 California Biomedical Industry Report
A BayBioreport, in collaboration with CHI and PwC: http://www.californiabiomedreport.com/
The 2013 report found California to be:
As the center of biomedical innovation in the U.S, California’s biomedical industry is a national treasure. But the pace of R&D productivity and its global leadership position hang on the availability of capital to fund future innovation and a regulatory framework that is based on consistency and innovative technologies.
The 2013 Biomedical Industry Report found:
I wanted to share the following article with you, borrowed from the Drug, Discovery & Development online magazine:
Drug development programs today have a 5% to 10% probability of success. Almost half of the failures are due to drug safety issues found very late in the clinical development process. The lack of improvement in outcomes, despite advances in technology and the near doubling of pharmaceutical R&D expenditures, highlights the need for novel approaches to drug development.
Currently, the identification of efficacy and safety risks for a lead compound primarily uses cell line and in vivo studies. Unfortunately, these experimental systems are black boxes that offer limited visibility into selected phenotypes and biomarkers and very little insight into the effects of a compound on important physiological pathways. Due to this lack of transparency into pathway effects, it is difficult to generate insights into system-level changes in the physiological network. This is often a reason for potential oversight of toxicity issues and incorrect assessment of efficacy.
In the era of molecularly targeted drugs that affect specific targets and pathways, developers must have insights into the off-pathway effects of drug candidates. Use of predictive methodologies that emulate human physiology to test the impact of the drug candidate prior to moving the drug into clinical testing is crucial to improve the drug development success rate. By predicting clinical outcomes early on, the success rate of drug development can dramatically be improved.
The development of a predictive system emulating disease physiology is feasible because of the massive amount of published reductionist information on signaling and metabolic pathway components and “omics” data coupled with advances in mathematical techniques and computing power. Coupling the massive library of published data to computing power enables researchers to connect the dots in a way not possible before and, therefore, predict clinical outcomes early on.
Predictive models offer the promise of predicting clinical outcomes early in the development process and give the ability to rationally construct efficacious therapies with lower potential for side effects. The large availability of data and information on the components of the biological networks and interactions has enabled the creation of such systems. This approach provides transparency to manipulate different pathways in the network and assay intermediate and endpoint biomarkers and disease phenotypes. The key criterion for deployment of such an approach is extensive validation of predictions with experimental studies.
About the author - Pradeep Fernandes has a background in semiconductor engineering and has applied the engineering approaches and technologies to create the Cellworks technology platforms. Shireen Vali has a background in molecular and cellular neurobiology and has worked extensively in developing the disease networks underlying complex multi-phenotype disorders.
Marketing & Communication Coordinator at Clinovo
How is the growing adoption of EDC affecting CDMs? Is processes automation easing or threatening the work of CDMs? How is systems integration changing the required skillsets of CDMs and how to adapt? The Clinical Data Manager today: Emergency-based fireman or provident manager?
The evolution of technologies in clinical trials leads to a redefinition of the CDM role. The fast-pace adoption of EDC systems reduces the overhead of manual cleaning tasks and time-consuming back-and-forths. As a result, CDMs are asked to handle a far greater volume of complex data streams. They are also expected to spot and solve problems at earlier stages, and to collaborate with statisticians and site monitors to set specifications for validation and edit checks prior to data collection.CDMs are becoming a key cross-road and take on the role of information providers in their organization with the sponsor and sites. They need to understand the entire clinical development spectrum and how data fits.
Today, Clinical Data Managers are not only Clinical Data Managers, they can also be projects managers, programmers and in some cases medical managers, quality or regulatory experts. This inflation of competencies lead to the development of a new generation of cross-trained CDMs, eager to match their skillset with the job market expectations. CDMs have been taking on new responsibilities within their organization and benefit from additional professional opportunities.
Do you want to learn more and react on the topic? On October 24th, Clinovo will broadcast a free webinar on the Changing Role of the Clinical Data Manager. This webinar will benefit CDMs but also industry professionals looking for ways to understand and benefit from upcoming trends in the Clinical Data Management field. The presentation will be followed by an open discussion on the topic.
Clinical trial sponsors looking to stay at the forefront of efficiency and accuracy should consider whether they are making the best use of the growing trend of access to clinical data on mobile devices. From the secure sharing of electronic patient reported outcome (ePRO) data, to creating more flexible clinical data management, mobile technology has the potential to improve processes across the clinical research process. In many cases, sponsors are already seeing the benefits – including real-time alerting capabilities and increased efficiencies – of incorporating mobile technology in their research process.
Real-time results – delivered to the right people at the right moment
Real-time alerting can dramatically improve a trial’s overall success rate. Alerts can be configured to automatically send an email or text message to a mobile device when a pre-specified event occurs, such as when a serious adverse event (SAE) is entered into the system. It is important that alerts notify mobile devices; most people are not always logged into their computer workstation, but many keep their smartphone or tablet close by. This helps ensure that all relevant stakeholders are informed as quickly as possible when their action is required. For example, if a patient in Sweden reports symptoms via their iPad after intake of Drug X, their information can be instantly analyzed in California, where a data manager will be notified that he or she needs to take appropriate next steps, which may include alerting sites across the globe to suspend the use of Drug X. With the use real-time notifications delivered through mobile devices and the ability to act upon this feedback from any web-enabled device, response times can be reduced from days or weeks to hours or minutes, giving clinical teams the opportunity to address problems before they put a study in jeopardy.
Consumer-based efficiency – taking advantage of familiar technology
Increasing trial efficiency and correctness are common requirements for CROs and trial managers when implementing new clinical trial technologies. Luckily, mobile devices and their efficiency benefits can be easily introduced into the research process without costly hardware investments or extensive user training. Most trial participants and managers currently utilize mobile devices in their everyday life, so the functionality is already available. Because participants are using a technology they already understand, it becomes easy for them to enter data directly. In addition, trial participants will be more likely to engage with tools they’re already familiar with, enabling increased accuracy and improved reporting. And because of the connectivity of mobile devices, it is easy for trial managers to retrieve data from patients without costly delays.
Data security concerns – succeed with caution
In order to make mobile capabilities a research reality, we can’t ignore the possibility of security threats and regulatory concerns. However, mobile software can be very secure if written properly, and the clinical trial industry can benefit from the great strides other industries such as online banking have made in mobile security. Similarly, regulatory concerns can also be addressed by ensuring mobile software is fully Title 21 CFR Part 11 compliance. Data security is a risk in any electronic platform, but when addressed carefully, its risks need not outweigh the vast benefits that electronic technologies provide.
Propelling into a mobile-charged future
As the clinical industry becomes more dependent on technology, waiting for results or data batches to be complete will no longer be acceptable or considered the norm. The ability to increase efficiency, analyze live data and implement results immediately demonstrates collectively the key benefits of utilizing mobile devices in clinical trials. Taking advantage of new and innovative technologies is a key to the future of clinical trials, and mobile capabilities will pave the way.
CEO, Comprehend Systems
Rick Morrison is the co-founder and chief executive officer of Comprehend Systems. Prior to founding Comprehend Systems, Rick served as the chief technology officer of an internet-based data aggregator, where he was responsible for product development and operations. Rick has over a decade of experience writing software for clinical trials, including tools that are now used by the FDA and top pharma. Rick holds a bachelor’s degree in computer science from Carnegie Mellon University.
It is a very exciting time for Clinovo! We are now officially launching our TechTrainings, a new opportunity for a successful career in the clinical trial industry. These hands-on classes enable entry-level or already experienced clinical trial professionals to improve their skillset. Real-world case studies were designed with 10+ years experienced professionals to help our students reach the next step in their career.
Please visit this page to check out the first session 101 Clinical SAS Programming by Jennifer Kang, Senior Statistician at the Palo Alto Medical Foundation Research Institute (PAMFRI). We know it takes time and effort to “go back to school” so we came up with a convenient format: one 3-hour class per week during 10 weeks. If you happen to know anyone interested in learning SAS, note that you can win a $50 giftcard and your friend can benefit from a discounted registration.
Some of our readers and followers expressed the need for other trainings in the future. If you think of another major topic for which Clinovo’s expertise is needed (CDM, EDC, CDISC, clinical trial design, etc.) feel free to comment this article.
Marketing & Communication Coordinator, lead for Clinovo TechTrainings.
The cloud: A new paradigm
The cloud generated $36.1 billion dollars in 2011 and is expected to reach $72.8 billion by 2015 according to a recent IDC study. With a CAGR of 21% per year from 2011 to 2015, the cloud is growing three times faster than traditional IT infrastructures. It is nowadays a commonly known revolution, yet very few people grasp the nuances and the potential behind this term. In simple words, the cloud turns everything into easily accessible and affordable services, unleashing unmatched potentials for organizations and individuals.
Defining the Cloud
The cloud is the ability to access value-added services from anywhere at any time with a level of simplicity, flexibility and cost efficiency never met before. The cloud provides on demand access to software/applications, platforms and infrastructures commonly known as:
- Software-as-a-Service (SaaS) such as web hosting services, collaborative or CRM applications such as the well-known Salesforce.com.
- Platform-as-a-Service (PaaS), providing developers the tools to develop their own applications such as databases, operating systems, etc. without any initial costly IT investment in hardware. For example Google’s App Engine is a PaaS enabling developers to create new applications.
- Infrastructure-as-a-Service (IaaS) enables access to computer infrastructures such as servers, data-centers and network equipment, once again without any heavy initial investment. This type of cloud service is often used by organizations that have the IT expertise to manage their IT requirements but not the infrastructure itself. For example, Amazon’s Elastic Compute Cloud (EC2) provides resizable compute capacity to make web-scale computing easier without the need for CAPEX.
Those three categories are called “services” in the sense that users access, subscribe, use, monitor them on an on-demand and pay-as-you-go basis. The user can monitor the Service Level Agreement (SLA) he signed for, submit tickets if necessary, look at its IT usage bill on its own, without any human interaction. The cloud is thus a very automated, elastic and cost-efficient environment.
This level of autonomy is possible thanks to processes automation: Workflows are automatically processed in the cloud without human intervention. The advantage of process automation is cost-efficiency since less IT hours are billed. Today, around 70% of IT budgets are spent on maintaining the infrastructure, leaving only 30% for new projects. This tends to frustrate departmental managers who see their projected queued, sometimes for years. The cloud provides an immediate and cost effective solution while empowering these managers.
Clouds rather than Cloud
Traditionally the cloud is split into four types:
Cloud technology in the life science industry
Clinical trial professionals already use public clouds but mostly for administrative, IT, marketing or sales purposes (such as Google Drive, any document sharing system or CRM tools) but very few of the cloud services are directly related to life science.
Although cloud-based systems are gaining momentum in almost all the industries, the adoption rates for this innovative technology remain low in the life science industry. Some IT vendors in clinical trials such as Medidata Rave are arguing they are offering cloud services, whereas their services are neither self-service nor on a pay-as-you-go basis. This is not uncommon; many companies exploit the cloud marketing buzz, yet provide services that are not self-service, automated, flexible nor cost-efficient.
In clinical trials, cloud technologies are a new opportunity to lower skyrocketing costs. Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS) or ePRO systems would be configured and implemented at a much faster pace and at a much lower cost. In January 2012, Forbes calculated the average cost of bringing a new drug to market at $1.3 billion (at times $4B to $11B for big pharmaceutical companies), this calculation takes failed drug application in account.
Thanks to the always-on and automated properties of the cloud, drug development cost is bound to decrease since clinical trials will be started and ended faster than ever before.
One of the major concerns of pioneering cloud computing for the healthcare industry is compliancy. Pharmaceutical companies must ensure that the cloud service providers they use follow GCP as guided by 21 CFR Part 11 regulation, to ensure the system is fit for its intended use; including IP/IQ (Installation protocol and qualification), OQ (Operation qualification) and PQ (Performance Qualification). Here are some tips about validating a clinical application in the cloud:
- You must have an installation protocol to install the application into the cloud; as well as for every minor and major version upgrade.
- In a public cloud you cannot have an installation protocol for installation of the hardware and OS images. More and more auditors understand and accept this is a limitation of the cloud. Do check with your QA department, if in doubt.
- You must provide test and production environments for each application in the cloud.
- You must test backup and restore of all production applications.
- It is a good idea to test your disaster recovery procedures. You may need the cooperation of your cloud provider to simulate a disaster for you.
- Validation of the application must take place in the cloud and you must use the same documentation and methods as if the application was running on a local server.
Since clinical trials are more and more international, there is also a need to ensure that local regulations are followed. For example it is essential to know where the data is hosted. Indeed some countries require the clinical data to be hosted in the actual country of the clinical trial. For example, if a pharmaceutical company runs a clinical trial both in the US and in Japan, the Japanese data must be hosted in Japan. This regulation should be taken in consideration while implementing a global cloud-based clinical system.
Even though the cloud is promising autonomy, flexibility and cost-efficiency for pharmaceutical companies, there is a need for experts to ensure that the transition to cloud-based services for clinical trials is made in a safe and compliant manner. IT and life science are two very different areas of expertise, so it is critical to take the time to choose a vendor that has proved its worth in both area and that can guide you through this new technology.
Ultimately, the cloud technology will revolutionize the healthcare and life science industries, enabling pharmaceutical companies to bring their drug to patients faster at a lower cost.
At Clinovo, we pride ourselves to seek and bring the most innovative technologies and apply them to the life science industry to streamline clinical trials. Our team is composed of experts in both the IT industry and the life science industry
Marc Desgrousilliers, Chief Technology Officer at Clinovo
Olivier Roth, Marketing & Communication Coordinator
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