There is a lot of pressure on cancer survivors to participate in clinical trials. Without the brave individuals willing to participate in the trials research would grind to a halt along with new, improved treatments for all cancers.

Even though an estimated 2.3 million people in the United States take part in clinical trials every year and researchers struggle to find additional willing participants many complain that they never find out the results of the trial, even after they take the potentially significant risks inherent in many trials. There are no requirements that researchers share the results of the trial with participants. Many trial participants feel anger confused, frustrated, and, in some cases, lacking information that may be important to their health.

To help eliminate this problem researchers at the University Of Rochester Medical Center have proposed a new approach to disseminate the results of clinical trials to study volunteers and deal with this significant oversight.
Currently, researchers are only required to inform participants when new information arises that may affect a volunteer’s willingness to continue their participation in the study. Rarely do federal guidelines or institutional review boards require disclosure of results at the conclusion of a study – even if the study is halted because of negative effects. The result is that many research participants never learn the outcome of studies in which they volunteer nor the potential problems that might affect their future health.

The neurologist Ray Dorsey, M.D., the report’s author said, “Individuals who volunteer to participate in clinical research frequently expose themselves to risks, both known and unknown. Because of their participation, they should be informed of the results of these studies in a timely and personalized manner.”

Dr. Dorsey discussed a recent trial for a drug to treat Huntington’s disease. The trial showed there was no significant difference between the trial drug and placebo. In this trial, the researchers developed a plan designed to inform participants of the study results directly within 48 hours of the official release of study results.

Their communication plan included both electronic communication and personal outreach. All information on the results was posted to the study’s website and emailed. Additionally, the study coordinators called each of the participants directly on the phone. The study’s principal investigator and the CEO of the pharmaceutical company also held a conference call, which was open to all study participants, and investigators during which they summarized the study results and then fielded questions from all the call participants.

Once the communication efforts were completed, the researchers surveyed the participants and found that more than half (56%) learned of the results of the study within 48 hours of the initial public release. The important part is that study participants reported a high level of satisfaction with the way results were communicated. Additionally, the participants developed a strong understanding of the drugs benefits and risks.

Study participants are a critical part of research efforts, both in fund raising for basic research and as active partners in the actual research. It is time that participants are shown the respect and courtesy due a research partner. Researcher’s efforts to recruit clinical trial participants will be enhanced by participant’s reporting positive feedback to their peers (potential other participants in other studies) and by increasing the willingness of participants to enter into another trial. The time has come for federal legislation and for IRBs to require timely communication with all clinical trial participants.

Dorsey et al. Communicating Clinical Trial Results to Research Participants. Archives of Neurology, 2008; 65 (12): 1590 DOI: 10.1001/archneurol.2008.503

Joel T Nowak MA, MSW