Patient-centric research is a concept that puts patients at the heart of a clinical trial. In practice, this comes down to their involvement throughout the lifecycle of a study. In this Q&A, Jill Platko, Ph.D., senior scientific advisor at CRF Health discusses why patient voice is so important in clinical research and what is needed for successful patient engagement.
Q: Why is patient voice important in clinical research?
JP: Ultimately, the purpose of clinical trials is to produce products that help patients. This means patients are an important part of this industry. It’s counter-intuitive to then ignore them during the research phase, so we feel it is ethical to involve patients. On a practical level, patient recruitment and retention can be an issue during a study, and who is better to assist a study with understanding how to find and keep patients engaged than the patients themselves? We are very shortsighted if our studies fail because we didn’t involve a key stakeholder.
Q: How can clinical trials be patient-centric?
JP: During study design, patients may provide feedback on assessments and schedules or review recruitment and retention strategies. During the study, the patient participants’ needs should be the first consideration. Accommodations need to be made to keep the burden of participating in a trial as low as possible. Examples may include informed consent forms with multimedia components to maximize understanding, easy-to-use data collection systems, reminders and guidance to help keep them on track and engagement strategies that recognize them as individuals. Many studies also require patients to come in for frequent site visits and visits may be long and demanding. Many sponsors are considering strategies on reducing travel to sites while enabling patients to keep in touch with site personnel. In some studies, it may be appropriate to share a patient’s data with them during the study. Once the study is complete, patients should be informed of the result of the study they participated in.
Q: How do you measure success?
JP: During the consenting process, success can be measured by a patient’s understanding of the study through a follow-up quiz. Using this approach, a study has revealed that patients do learn better with multimedia. Using eCOA also allows insight into success of engagement measures since we can track a patient’s compliance with completing assessments. In addition, utilizing thoughtful measures on patient satisfaction with trial participation could produce useful metrics and further insight, especially when applied across studies for comparable data. The ultimate measure of success for all the patient centric efforts may be the patient recruitment and retention numbers. The overall rate of participant withdrawal is currently 30%1. If our efforts as an industry are successful, we should see that number drop.
Q: What are the challenges for engaging patients in clinical trials?
JP: Forte Research has published 12 reasons why patients withdraw from studies. Some of these reasons we may not be able to address such as withdrawing because of intolerable side effects. Others, however, can be addressed by understanding the patients’ needs and accommodating them. For example, participants withdraw because they didn’t have a clear understanding of the study. We can address this by providing better learning tools for the consent process such as using a multimedia approach. It should be noted that different patient populations have different needs, so research should be done ahead of time to define those needs.
Q: What is needed for successful patient engagement?
JP: Accept that patients know best what their challenges and interests are and what would work better for them. Get the patients involved from start to finish.
You can read more about Jill’s thoughts on this subject by taking a look at a recent issue of PharmaVoice, where industry experts look at what works and what doesn’t when it comes to patient-centered trials.
For further information on CRF Health’s solutions, please visit www.crfhealth.com