Participant/site burden series “I didn’t know what I was getting into”

Recruitment and retention are significant challenges for clinical trials. When a candidate for a study signs the consent and agrees to participate in a clinical trial, they’re making a significant declaration. They are declaring that they are willing to give of themselves and their body for medical research. This is a most sacred thing and should be treated as such.

As researchers, we have a commitment to do our best to educate and inform the potential participant of all the relevant aspects of the clinical trial. The better informed the individual is, they are more likely to be compliant with study procedures and retention will be improved.

Many sponsors attempt to achieve this through lengthy consent forms. This is not the answer. These ridiculously long consent forms achieve the opposite. They confuse and overwhelm trial candidates.

Sites often provide the ICF for the participant to take home, discuss with their family members and possibly their family physician before deciding. This is a well-intentioned initiative but falls short thanks to the poor writing of the ICFs.

The sad result is sometimes individuals agree to participate, sign the consent form, but don’t really understand what they’re getting into and all the requirements the study entails.

Fast forward three months, six months, a year… and the participant finally has enough with the burden of all the study requirements and they want out.

Instead, more time should be spent with the individual prior to and during the consenting process. In plain language, the study (and clinical trials in general) should be explained to them. It should be a relaxed and unrushed experience.

The individual conducting the consent discussion should be well trained and not just on the basic GCP requirements. They should be fully trained on how to answer the tough questions we get from potential participants. Questions surrounding placebos, potential risks, and benefits. Questions about what happens at the end of the study or if the study just isn’t a good fit for them. How much time is spent training study coordinators and investigators on how to answer these difficult, yet critical questions (and how to answer them with clear, honest, and empathetic responses)?

Are there any resources out there for sites to help train their staff how to answer these important questions?