When we consider the impact of data sharing, there are three different viewpoints to consider:

  1. Medical and Research Professionals
  2. Patients
  3. General Public

In other blogs we have focused on the Medical and Research Professional needs for the sharing of clinical trial data. In this blog we will look at the need from the patient’s perspective.

Patients support the greater data sharing and transparency as noted by the expert panel that reviewed the IOM report on Sharing of Clinical Trial Data. Patients understand the benefits of data sharing include maximizing patient contributions, preventing unnecessary research and the in the end better medical research and development. But recruitment and retention for trials continues to be a challenge given the distrust by the public on clinical research. A 2013 CISCRP (The Center for Information and Study on Clinical Research Participation) survey of public and patient perception found that 28% of the 6,000 respondents believe that sponsors do not inform the public in an expedited manner regarding the safety concerns of the drugs they might be using.

The Society for Clinical Research Sites (SCRS) support the sharing of results of clinical studies with patients. The SCRS believe the lack of transparency feeds the public distrust and makes it harder for sites to recruit these volunteers for future studies. The failure to share information with patients from previous studies makes it impossible to ask the patient to enter any further studies.

Patients want to know how they did in the overall study as well as the overall outcome of the study. The SCRS believes it is unacceptable that they can not share this information with the very people who volunteered for the study. With the FDA’s post market requirements to follow patients for a prolonged period of time after approval, it becomes imperative that data sharing include patients involved in trials.