In clinical trials, volunteers play an important role. However, their experience is not always optimal. Paul Wicks, former VP of Innovation at PatientsLikeMe, once said in an interview with Newsweek, “sometimes it’s as bad as dealing Comcast or with the worst airline.”
Both patients and sponsors are affected by a negative experience. The cost of research increases when patients are kept on longer. Prioritizing patient-centric design in trials can improve the patient’s experience and increase the success of the study. Sponsors can ensure that potential treatments are aligned with the needs of patients, the endpoints measured are meaningful, and testing methods are acceptable. What does prioritization mean? We have compiled a list of tips that will help R&D teams ensure patient-centricity in the design of trials.
How to design patient-centric trials
Consult patient advocacy groups. Due to their close relationship with the patient community, patient advocacy groups are an excellent resource for trial design advice. Patient advocacy groups are often able to help sponsors think about the trial structure, inclusion and exclusion criteria, and the impact of participating on patients. These groups will often be happy to provide feedback on the purpose of the trial and its logistics. They may also be able to connect you to patients for interviews. A recruitment agency that has established relationships with such organizations can facilitate these discussions and be a valuable resource.
Reach out to patient influencers. Patients who are part of online grassroots communities are more likely to be willing and able to share their experiences and provide input on study design. Searching for disease hashtags and following Twitter threads will help you identify the most influential and active groups.
Consider a live protocol simulator. This is a way for sponsors to invite patients to a trial appointment dry run. It is a great way to see if the protocol will work in real life. In one case, AstraZeneca held a lupus trial simulation in order to gauge how patients felt and to receive suggestions on how to improve their experience.
Use real-world data. Accessing patient data from past trials or searching for previous trials can be a valuable tool to learn what the experiences were in the past. This data can be used to identify contributing factors, such as inefficient targeting or difficult site processes. Sponsors can then determine which elements of the trial design should be changed to ensure patient-centricity.
Antidote can help you design or recruit a clinical study. We are here to assist you with real-world data and relationships with patient advocacy organizations, as well as full-service recruiting options. Contact us today for more information.