While moral issues are paramount, a strong patient-centered informed consent process can also improve retention and patient compliance, says long-time industry expert Susan Warne, associate site and patient networks director at QuintilesIMS.
However, a patient-centric program must not focus solely on the individual in the trial. Trial practitioners should engage other family members and friends who may be involved in the patient’s treatment regimen, Warne says. “Make sure everyone understands the impact of the treatment,” she adds. For example, a patient might be getting a ride from a friend each visit to the study site; it’s important for both the driver and the patient to understand the importance of keeping treatment appointments.
It starts with being proactive. “It’s not the patient’s responsibility to ask questions,” Warne stresses. For example, if a patient says he or she is participating because a doctor suggested it, probe deeper. “Well, it’s more than that. Tease out the reason for their interest and make certain they understand alternate treatments” if any are available, Warne says.
Coming Soon! ACRP Launching New eLearning Course – Implementing a Patient-Centered Informed Consent Process. This course will help improve your informed consent process by teaching you how to assess a participants’ reading level, health literacy, and overall understanding of clinical trial participation while addressing culture, learning styles, emotional states, and language. A critical course for integration of patient-centered practices in your clinical trials.
Don’t fall into the trap of “dotting I’s and crossing T’s,” Warne notes. “[Informed consent is] an ongoing process that should be a part of every patient encounter.” In addition to communicating any protocol changes as soon as possible, ask patients each time you see them if they still understand what’s going on in terms of their trial.
Well-informed patients are usually more compliant to the expectations of the research protocol, Warne says, because they understand they are a part of something bigger than themselves. Failure to maintain their compliance and participation can gut an expensive study. “If too many people drop out, the Food and Drug Administration will say your data are not valid,” Warne explains.
Among other tools, Warne advocates giving patients an easy-to-read guide that accompanies the actual consent form. “We need to always be looking for ways to do this better,” she says.
Author: Michael Causey