The issue of transparency and disclosure of clinical trial data has been growing in importance over the past few years. Clinical trials are essential to developing new therapies for patients. But the individuals that participate in those trial put themselves at risk. In return, the medical community has an ethical obligation to disclose clinical trials information and create transparency around the data. These steps are critical for increasing trust between the public and the industry.
In addition to the ethical mandate for transparency, there is also a business case for treating study volunteers as partners in medical advancement. In surveys of the factors that motivate participation in clinical research, volunteers most frequently cite reasons such as wanting to “learn about their disease,” and “feel part of a community.” The overwhelming majority have positive experiences that they might be willing to share with others, except for one pervasive issue. 90% of clinical trial volunteers expect to be told the overall results of their trial. Unfortunately, most never hear anything back from the sponsor or research center after the last study visit, leaving many volunteers wondering if their participation mattered or was appreciated. The persistent perception that clinical research volunteers are “guinea pigs” rather than people may contribute to low levels of participation in medical research. In fact, the average study has to last for twice the planned duration in order to meet the enrollment target.1 Increasing the public’s trust in the clinical trial process may help increase participation and retention rates, which should help lower the overall cost of drug development.