gms | German Medical Science

Aim: Trial registries have become an important tool for transparency in drug development. They are also considered to offer patients opportunities for study participation. Therefore, we wished to explore the role of trial registries for patient involvement and participation in clinical studies.

Method: A survey was sent to the largest 20 pharmaceutical companies as defined by 2009 global net sales.

Results: 16 companies responded among which 2, 4 and 10 companies reported registering less than 50, 50–100 or more than 100 studies per year, respectively. Each company listed the five most important indications in which they have clinical studies. All participants indicated to adhere to clinical trial registration requirements as defined by the US Food and Drug Administration Amendment Act (FDAAA) and the US State Maine Law. 15 companies claimed to adhere to requirements of the International Committee of Medical Journal Editors (ICMJE), and 11 also followed the requirements of the World Health Organization (WHO). All reported to apply this to phase II-IV and to post-marketing surveillance studies; all but one also applied this to phase I studies. 11 companies received patient inquiries related to registered studies. 12 companies received inquiries from patient advocacy groups. 10 companies received inquiries from physicians. Moreover, 4, 3 and 5 companies haven’t received any inquiries from any of these stakeholders. Only one company received inquiries for registered studies from a physician organization. Accordingly, 9 companies reported that patients had volunteered for recruitment based on clinical trial registries; this occurred directly from the patient, via their physician, via a patient advocacy group or via physician associations in 7, 5, 9 and 0 companies, respectively (multiple nominations possible). All respondents indicated that less than 30% of study participants were recruited based on ClinicalTrials.gov. 6 companies reported not having experienced any recruitment in clinical studies based on trial registries. All respondents rated its role for recruitment as poor but considered the role of this registry for recruitment to increase in the future.

Conclusion: Based on participation by 16 of the top-20 pharmaceutical companies, representing most areas of medicine, this survey is likely to be representative for the global pharmaceutical industry.