Nearly all study volunteers want to receive the results of their clinical trials. Regardless of the outcome, participants want any information available that could help them make critical health decisions, and they want to know that their involvement helped others living with disease and illness. In fact, receiving study results is one of the top reasons patients choose to participate in a clinical trial, ranked even above the ability to access free medical care.
Pharmaceutical companies and government agencies sponsoring clinical trials are obligated to share these results. However, for the majority of clinical trials conducted each year, study volunteers don’t receive their results. Most patients first learn about the outcome of their participation only after a general announcement has been published in the newspaper or broadcasted in the news. For many study volunteers, the end-of-study experience often leaves them feeling dissatisfied and unappreciated.
Ways to access results
Some clinical trial results are posted on the websites of pharmaceutical companies. Also, federal law requires that clinical trial results are routinely posted on a government website called ClinicalTrials.gov within a year of study completion even if the drug or medical device being tested hasn’t been approved. These results, however, are not usually shared with study participants. Most people find the government website very difficult to navigate. For those able to locate their specific clinical trial, the results are presented in highly technical language, which makes it hard for not only patients, but also physicians and other health-care providers to understand.
There is good news, however. A growing number of pharmaceutical and biotechnology companies sponsoring clinical trials want to deliver results in non-technical, plain language summaries to their study volunteers. At the moment, research sponsors are mainly focused on providing general clinical trial results, but some companies are piloting initiatives to share more detailed, personalized findings with their study volunteers. In the future, study volunteers could potentially attach their own data from clinical trials to their electronic health and medical records, allowing them to share the results with whomever is providing treatment.
What to ask your doctor
If you, a family member or friend is considering a clinical trial, be sure to ask if the clinical trial results will be shared. Carefully think about whether you want to participate in a clinical trial if there is no guarantee that the results will be provided to you. If a plain-language summary of the results will be provided, you should ask what options you have for receiving that information. Most study volunteers prefer to receive a printed report, but a growing number of study volunteers are choosing to receive a digital version of the results.
If you have recently participated in a clinical trial, ask your doctor or nurse – or the study staff – to help navigate the clinical trials website or the pharmaceutical company’s website to locate information about your clinical trial. Your nurse and doctor also can be helpful in translating medical jargon into easy-to-understand language.
Study volunteers want to know the outcome of their participation in clinical trials and that their participation mattered. As partners in the clinical trials process, study participants should expect to receive — and those sponsoring or conducting the research are obligated to provide — plain-language result summaries.
Ken Getz, Founder and Chairman, CISCRP, [email protected]