Updated on 4 July 2012
It is time to call for nothing less than a complete overhaul of the recruiting process to focus squarely on the patient and redefine the way we look at clinical trials, as if we were the patient.
This would lead to:
The informed choice process
This would require using clear health communication principles and a complete overhaul of the training, which site coordinators and recruiters receive, to include psychosocial training.
Some of the sites have done extensive work in simplifying the informed consent process for patients, while also ensuring that it meets IRB standards. They have developed a one-page graphic schema that helps research volunteers understands an entire research protocol and their role in it. It is important for us to realize that patient trust in the sponsor is critical; without trust high attrition is a predictable problem.
The clinical trials sites could set up patient-to-patient mentor programs, as well as online communication between participants and site coordinators. Another approach is to involve patient advocacy organizations, which already have infrastructure and communication venues in place, to guide people through the process so that they are not lost due to information-overload.