Today, the involvement of patients and caregivers in planning clinical trials is an increasing requirement from research funders and regulatory authorities (the agencies that approve medications for public use), like the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The governmental and private organisations that pay for public healthcare and public research are also seeking confirmation that patients were consulted on important trials for potential new treatments. Partnering with Patients in the Development and Lifecycle of Medicines.1
Researchers are devoting more time and effort to explaining the aims of the research in ways participants can really understand and welcoming questions and feedback. It is also now a formal requirement in Europe that trial sponsors share a summary of their trial results with participants, written in non-technical language. Good Lay Summary Practice Recommendations are now published in EudraLex.2