Clinical Trial Participation Levels Are At All-Time Low: Reports

Researchers warn that not enough people are signing up for clinical trials, raising concerns that the development of new drugs may be delayed or not thoroughly tested before being released to the public. 

According to a report published by the Wall Street Journal last week, fewer than 10% of Americans participate in clinical trials, and in many cases, they are not even told by physicians that taking part in such studies involving new treatments are an option.

Many patients who are aware of the possibility of clinical trials are afraid of being a test subject, according to the report. In addition, those who do volunteer often have to jump a number of hurdles, such as eligibility requirements and protocols.

The report estimates that about 40% of clinical trials do not recruit enough volunteers to meet their stated goals.

The findings comes as the FDA seeks ways to streamline the clinical trial process, particularly involving medical devices. However, recent research has raised concerns about the lack of follow through on required studies by many medical device and drug makers.

Although many of the clinical trials required by federal regulators are never completed, or not even started, the FDA often approves the products and allows them to stay on the market anyway. Therefore, many consumers receiving recently approved treatments become essential test subjects without ever being told or consenting, since they are serving as ginnie pigs for products that were never properly tested before approval.

In August 2015, a study published in the Journal of the American Medical Association (JAMA) looked at data on high-risk therapeutic devices that received premarket approval by the FDA in 2010 and 2011, determining whether manufacturers had completed required post-approval studies (PAS), which are conducted after the device is already made available to healthcare professionals and consumers.

The findings indicate that only six of 33 PAS studies required by the FDA were actually completed, and only 20 of 171 manufacturer/investigator-initiated post-market studies were reported as complete.

The findings came about two months after an analysis published in BMJ found numerous discrepancies in data submitted to the FDA by medical device manufacturers seeking premarket approval for cardiovascular devices. Those discrepancies often included the number of participants varying in the actual study from the number reported to the FDA, substantially different results from similar FDA studies, and many of which were never peer-reviewed.

The findings also came at about the same time as the FDA released a new report on it’s role in medical device safety. The agency says it has made significant strides in ensuring medical devices are safe and effective, including in how it reviews and requires clinical trials.

According to the Wall Street Journal, the FDA and Duke University have launched the Clinical Trials Transformation Initiative (CTTI), which is preparing to release new recommendations on how researchers should work closely with patients, doctors, and advocacy groups for specific diseases.

The recommendations follow research that indicates that patients with a higher level of trust in their physicians are more likely to become involved in clinical trials, and that trust can be strengthened by investing the patient and other stakeholders in the trial.