Clinical Trials - Discovering and Sharing Knowledge

Clinical Trials - Discovering and Sharing Knowledge

02.02.13 | By Matt Bennett

Developing a new medicine to fight diseases such as cancer or diabetes can require 12-15 years of research and over $1 billion. As seen in Catalyst posts earlier this week, a foundational aspect of the research is scientifically rigorous, well-regulated clinical trials.

Recently, critics such as Dr. Ben Goldacre have sought to cast doubt on this vital research, contending that information generated from clinical trials is incomplete and insufficiently shared.

Such unfounded yet sensational claims may generate headlines, but they do not help make new medicines. Clinical trials made possible the more than 340 new medicines approved by the Food and Drug Administration (FDA) over the last decade, and 35 novel medicines in FY 2012 alone. Criticizing the research process without acknowledging the vigorous oversight and commitment to safe and ethical conduct is a disservice to the tens of thousands of scientists exploring new medicines, the patients who participate in trials and advance our scientific knowledge, and the millions of patients hoping for cures.

Dr. Goldacre's calls to release all patient-level trial data pose a great risk to patient privacy and could discourage individuals considering participating in clinical trials and companies who want to invest in research. Inappropriate release of trial data could lead to second-guessing of the already rigorous regulatory approval process, which would be disastrous for patients and doctors. The FDA has the most advanced review process for potential new medicines, and it is continuously improving its scientific knowledge and regulatory capabilities.

The FDA releases a comprehensive summary approval package with each new medicine, which includes analysis of all significant clinical trials used for the approval process. FDA constantly monitors approved medicines and updates approved labeling accordingly. The approved labeling contains the synthesis of all known clinical data about a medicine. The Drugs@FDA database enables searches for information about FDA-approved brand name and generic medicines and therapeutic biological products, including labels, patient information, approval letters, and other information

Our current system includes sharing trial results with government regulators, the academic and medical communities, physicians and the public through submissions to the FDA, presentations at medical conferences and publication in peer-reviewed journals. As of February 2, 2013, ClinicalTrials.gov listed 139,847 studies with locations in all 50 states and in 182 countries. There is an enormous amount of clinical data available today.

The current clinical trials process is working well, fostering new medicines and spreading new scientific knowledge to researchers, physicians, patients and regulators. These committed participants in the clinical trials system are always seeking to improve, welcoming of constructive debates. Dr. Goldacre's claims may gain some publicity, but they cast accusations rather than seeking common ground.

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