Through the Patient Perspective: Collaborating to Improve Research and Development
At the October Metrics in Patient Centered Drug Development conference hosted by DIA, many of these key constituents gathered to talk about how to implement and measure the impact of patient input.
In the October issue of Applied Clinical Trials, editor-in-chief Lisa Henderson reported on the increasing role of collaboration in clinical trials as well as in the entire clinical development process. An ever-expanding area of collaboration is occurring between patient organizations, industry, regulatory, and governmental organizations to ensure that new drugs developed both represent value to the patients they aim to treat, and that the timeframe for providing new innovations to patients is accelerated. Leading the way are patient organizations who have formed sophisticated programs with the express purpose of integrating the patient’s voice, preferences, and interests into the drug development process. At the October
Engagement with Patient Communities
“Return on engagement” (ROE) metrics have been discussed primarily from the industry side to answer the question: what has a company gained from patient input into the drug development process? Most companies understand the why and that their success depends on putting the patient at the center of all they do. However, the how, i.e.-the way this is done, what works best, and how you capture value for purposes of refining and replicating best practice strategies is a main driver for the increasing emphasis on measuring impact. Sample metrics include reduction in the number of protocol amendments, faster accrual to trial, or increased retention rate due to patient satisfaction with the trial process.
Patients and patient organizations are invested in making sure new treatment innovations are both available and offer value aligned with patient needs, and know their voice is integral to the process. For that reason, they have fought for years to have a ‘seat at the table’ to ensure their perspective on unmet medical needs and the impact of treatments on quality of life are central to the drug development process. Patient organizations have taken it upon themselves to train patients on how to have input into the science of drug development. AIDS Treatment Action Group (A TAG) pioneered this in the 1980s and breast cancer took those learnings to create the National Breast Cancer Coalition’s (NBCC) “Project Lead,” a science training program for activists that significantly impacted breast cancer research and public policy. The result of A TAG and NBCC's work changed the way scientists, government agencies and industry design and implement research and programs.
Patient Voice Input Gathers Momentum
As demand has increased, so has the intricacy of these efforts, with the
The range of activities across patient organizations are diverse and progressive. For example, Ronald Bartek, Founder and President of the Friedreich’s Ataxia Research Association (
New Potential for Collaboration: Examples
Patient input into clinical trial design and protocols offers opportunity for sponsors to more closely align R&D activities with patient preferences. Two program examples illustrate new possibilities for collaboration.
The Parkinson’s Foundation has trained a cadre of Parkinson's Advocates in Research (
LUNGevity’s Patient Focused Research Center (
It is easy to see from these examples how collaboration with patients and patient advocates can enhance research and development efforts. What constitutes meaningful engagement and ROE for patients can be summarized as measuring how patients’ voices are heard and incorporated into research, policy, and health care practice behavior. As Ron Bartek puts it, these “more shots at the goal” translate into increased options for patients and faster recruitment to clinical trials with potential for bringing innovations to market more quickly. These are metrics we can all get behind.
Ellen Coleman, MSSA, MPH, is Senior Vice President with
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