There is no doubt that returning individual data creates potential risks for sponsors.
Irresponsible communication to patients can cause huge damage: mistiming the return of data can jeopardize a trial and delivering medical data in the wrong context can become an issue as well.
Proactive management helps to overcome these barriers with the following approaches:
1. Right timing of lay summary return: providing information to all patients, and offering those who were in the control group an opportunity to participate in another trial
2. Ensuring that any communication is written in lay language and reflects the clinical trial accurately, in consultation with the investigator when necessary
3. Include investigators in determining how and when data is delivered
Sponsors already use our Be the Partner Platform to give patient data back. If you are interested in how it works, please do not hesitate to contact us.