Clinical trials are crucial to understanding the safety and effectiveness of medications and medical devices. While the U.S. Food and Drug Administration (FDA) uses clinical trial data to evaluate new drug and device applications, clinical trial data has not been very accessible to patients. Transparency of clinical trial data is incredibly important for patients – they’re the ones taking the medication or utilizing the medical device after all. Luckily for patients, the FDA announced it is taking steps to make more clinical trial data easily accessible to those who will be most affected by any dangers or side effects – the consuming public.
FDA commissioner, Dr. Scott Gottlieb, has stated the agency is going to take steps to increase transparency. The first step in making clinical trial data more accessible is launching a pilot program to evaluate how releasing summaries of clinical studies impacts the public’s access to drug approval information. This first step will help the FDA understand how patients consume information about certain drugs and studies, thus allowing the agency to better cater to patients. The summaries will also be incredibly valuable to patients. While there is clinical trial data available to the public, it is often difficult for patients to understand the medical jargon.
In addition to a pilot program, the FDA is taking huge strides by linking information from its own database of clinical studies to the communications it sends out regarding specific trials. The FDA posts certain clinical trial data online which is available to the public. The agency is going to add identifying numbers to all clinical trials in the online database. This identifying number will link to any and all FDA communications regarding that specific study.
Previously, clinical trial data and the FDA’s communications and warnings regarding certain trials have not been presented together. This means patients could look up clinical trial data, but not learn about FDA warnings regarding the trial. FDA communications regarding trials often include information about injuries suffered by patients as a result of the trial, the discovery of compromised trial data, or other serious situations.
Putting Patients First
Patients have a right to understand all of the risks associated with any drug or device before choosing to utilize it. For some patients, this means more than just reading the prescription label. Patients have a right to understand the history of the drugs they take, from the laboratory testing to clinical trials on humans. By obtaining this information, patients have a much better understanding of the risks associated with a drug or device.