Dealing with the FDA today

Jul 17, 2012 by Clinovo    No Comments    Posted under: Best Practices, Best-Practices

The FDA’s mission is to protect public health by assuring “the safety, efficacy and security” of drugs. Indeed, the FDA has the tremendous challenge of ensuring sponsor companies deliver efficient treatments to patients while meeting the highest possible safety requirements.  FDA reviewers always need to thoroughly weight risks versus benefits. This sometimes has dramatic consequences: The FDA admits that in the United States 100,000 people die every single year taking FDA-approved pharmaceutical drugs. In addition to that, two million people a year suffer from serious adverse events, which include stroke, heart attack, and permanent neurological damage.

The FDA is increasing efforts to improve patient safety and identify potential side effects. It is more and more demanding with healthcare companies, trying to ensure qualified processes are in place . Indeed, while the number of FDA approvals per 1,000 US-based clinical trials has declined from 7.5 in 2004 to 3.1 in 2010, industry experts are facing increased complexity and cost when managing clinical trials. A 2010 PhArma report argues that between 2000 and 2007, the median number of procedures per clinical trial increased by 49%.

For a drug or a medical device, everything starts or ends one day in the walls of the Food and Drug Administration. What make the difference between failure and success are your clinical data and the way you deal with the FDA. This article intends to help you understand the secrets behind a successful FDA submission.

Provide regulatory compliant data

One of the new FDA expectations includes using standard format for clinical data for their submission. The FDA is thus gradually implementing CDISC standards. CDISC® (Clinical Data Interchange Standards Consortium) established these data standards to speed up data-review and improve clinical data exchange, storage and archival. CDISC standards have been acknowledged as recognized standards by the FDA for years now. They are gaining momentum and undoubtedly are an asset to accelerate the FDA review process. By 2016, CDISC standards are expected to be mandatory for any drug submission.

Understand and follow the FDA’s transformation

Staying up-to-date on any new initiatives is fundamental in order to always anticipate FDA expectations. The FDA is adapting to therapeutic-based clinical trials or personalized medicine. On the same note, the rise of orphan drugs forces the FDA to develop specific and shortened review processes. The FDA is continuously adapting to these life sciences developments. Christine Conroy, Vice President of Regulatory Affairs and GCP compliance at Affymax, points out that with the growing number of very particular compounds and patient-specific therapies, it has become sometimes difficult to provide data the FDA asks. The FDA sometimes lack experience in new fields such as biomarkers. Indeed, there is no reference point as everything is new, so it happens that the FDA brings up issues not always relevant in that field.

Find creative study design strategies to meet your endpoint

Small companies often lack financial or human resources to oversee CRO activities and analyze the quality of the data. This can be overcome by being more creative in the sponsors’ design strategy to reach the endpoints. Sponsors can for instance rely on open source based eClinical Systems (such as CDISC Express or ClinCapture marketed by Clinovo) in order to avoid expensive licensing fees and meet tight budget requirements.

Partner with the FDA

Transparency is an absolute pre-requisite in partnering efficiently with the FDA. It is critical to be detail-oriented and to think upfront to provide and anticipate the information the FDA will need and require. ​Having internal checking prior to the actual FDA submission is critical because “if you have questions or doubt about your data, the FDA will too”, explains Sandra Nino-Siddens, Executive Director of Regulatory Affairs at Geron Corporation.

Sandra Nino-Siddens claims that “sponsors should be straightforward in presenting rationale and steps followed to develop a safe product.” She outlines the importance of building good relationships with the FDA from the beginning and to keep forth-coming interactions with them. Sandra Nino-Siddens states that “the FDA should be seen as a as a long-term partner, and not be seen as the police, nor as a consulting company.”

Olivier Roth, Marketing & Communication Coordinator at Clinovo

If you liked this article, we recommend you to read: What is the prescription drug user fee act in a nutshell

Drug development time is money for some, life-and-death for others

May 24, 2012 by Clinovo    No Comments    Posted under: Best Practices, Trends

For years, critics have said the FDA’s medical device approval process takes too long, particularly when compared with the one in Europe. In the U.S., companies argue they lose valuable time and money as they seek to improve the lives of patients they serve.

This paper argues that the development process for experimental drugs could be accelerated without significantly endangering the Public’s health thus saving lives and cutting cost. Read more »

A New Way to Collect Data: CDASH by Anayansi Gamboa

Apr 23, 2012 by Clinovo    No Comments    Posted under: Best Practices, Best-Practices, Business Best Practices, CDISC, Clinical Data Management, Menu, Tips & Techniques

There is a general consensus that the old paper-based data management tools and processes were inefficient and should be optimized. Electronic Data Capture has transformed the process of clinical trials data collection from a paper-based Case Report Form (CRF) process (paper-based) to an electronic-based CRF process (edc process).

In an attempt to optimize the process of collecting and cleaning clinical data, the Clinical Data Interchange Standards Consortium (CDISC), has developed standards that span the research spectrum from preclinical through postmarketing studies, including regulatory submission. These standards primarily focus on definitions of electronic data, the mechanisms for transmitting them, and, to a limited degree, related documents, such as the protocol. Read more »