The Medical Device Innovation Consortium (MDIC) Science for Patient Input initiative has been working to promote patient-centered medical device development among industry. To that end, MDIC is working to compile best practices and create tools to make it easier for device companies to engage with patients throughout the development lifecycle. One facet of this effort is to increase patient engagement in clinical trials – not just participating as trial subjects, but providing input into the trial development process. The goal is to ensure trial designs reflect the preferences and values of the patients who will be served by the devices. This leads to trials that patients are more likely to enroll in, trials that measure the outcomes that matter most to patients, and trials that reflect the risk tolerance of the specific patient population.
First, to gain insight into current attitudes and practices for patient engagement in clinical trials, MDIC conducted three online surveys. One survey was aimed at industry representatives who work on clinical trials for their respective companies. The questions were related to how often patient feedback was sought while designing trials, what methods were used to obtain the feedback, what trial elements were affected by the feedback, and what challenges (if any) prevented more widespread effort in this area.
The second survey was aimed at patients, and was shared with patient advocacy groups to pass along to their members. The survey questions were related to the patients’ willingness to participate in trials, factors that motivate them to participate (or discourage them), experiences they’ve had with clinical trials in the past, and their interest in providing input during development of a clinical trial.
The third survey was aimed at clinical trial investigators. To ensure the investigators have experience incorporating patient preferences into their trials, the survey was shared with researchers who received funding from the Patient Centered Outcomes Research Institute. The survey questions were related to the methods used to obtain patient feedback, challenges to obtaining patient feedback, and what effects the feedback had on trial designs or execution. The survey responders were invited to participate in a telephone interview to expand on their answers and share best practices for engaging patients in the most productive ways.
The surveys of industry representatives and patients revealed some disconnect in understanding the things that motivate patients to participate in clinical research. There is definitely interest from patients in getting involved beyond simply being a trial subject, and there are some potentially simple things that trial sponsors can do to make trials more attractive to patients. The investigator survey showed that a variety of approaches is needed to engage patients broadly, and persistence is key (including both dedication from the researchers and consistent support from their institutions).
The complete report may be downloaded for free on the MDIC website.
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