CISCRP’s Communicating Trial Results program has had a very busy three months. Study sponsors are showing a strong commitment to providing lay language trial results to study volunteers, with several pharmaceutical and biotechnology companies piloting and expanding our initiative in their clinical trials.
In July, CISCRP was delighted to see the FDA formally recognize the need for volunteers to be informed about the results of their trial “in a clear and comprehensible manner”. It is our hope that more formal guidance is soon to come, and believe it is important for patients to see that regulatory agencies in the US are as aware and supportive of their needs as regulators in the EU.
Given the growing industry-wide and global regulatory agency interest in disclosing lay language clinical trial results to study volunteers, CISCRP anticipates an increasing number of sponsor organizations will support this initiative in the coming months.