For multiple perspectives on addressing this challenge, three respected individuals involved with the effort to bridge clinical research and clinical health care share their views.
Today, there is a transformation in health care — and for clinical trials in particular — to better integrate the patient perspective and ultimately provide greater access to new treatment options and improve patient health. For multiple perspectives on addressing this challenge, three respected individuals involved with the effort to bridge clinical research and clinical health care share their views:
- Jennifer Byrne, founder and president of Greater Gift and former CEO of PMG Research
- Ken Getz, MBA, director of sponsored research and associate professor at Tufts Center for the Study of Drug Development
- T.J. Sharpe, cancer survivor and patient advocate
Why patient centricity is critical
Jennifer Byrne perceives the bridging of clinical research and health care as a universal challenge with multiple objectives: Decrease the cost of care, improve outcomes and advance the patient experience. Unfortunately, many health care organizations do not have data on how many randomized patients are within their systems.
While more organizations are piloting patient engagement initiatives, enterprise-wide adoption has not yet happened. Patient input on protocol design would likely drive a stronger sense of participant buy-in, but Ken Getz points out that some organizations feel it would require too much time or delay the finalization or completion of the protocol. Other challenges include operating concerns such as workload, training and compliance.
To Getz, increasing patient engagement and participation requires a multifaceted approach that spans the clinical research spectrum, starting with patient input into protocol design and continuing through the return of trial results, so participants achieve full disclosure and transparency. Throughout the research, patient-focused technologies and practices such as wearable devices, e-consent and home nursing networks would contribute to the convenience and feasibility of patient participation.
Defining patient centricity in clinical research
Patient centricity starts with asking patients what is clinically meaningful to them. In his work tracking insights, trends and data on clinical trial design and execution, Getz has observed three aspects patients seek in their clinical trial experience: that the clinical trial is relevant to management of their disease; that their participation will be convenient and feasible; and that their participation is valuable in the clinical research process. Keeping these areas as a focus with an eye toward transparency, organizations can more effectively create a better patient experience.
According to Byrne, patient centricity starts with an obligation to serve all health care consumers. On a macro level, national health expenditures are projected to grow to nearly 20 percent of gross domestic product by 2025, outpacing projected GDP growth.1 Furthermore, health care debt is the leading cause of personal bankruptcy in the U.S. With health care costs rising for an aging population, reframing the value of clinical research is a way to mitigate those burdens for both individuals and the health care system.
From the patient side, clinical trial participant T.J. Sharpe encourages patients to push for better care: “That means holding physicians accountable for helping navigate treatment options (including clinical trials), holding industry accountable for better patient experiences and holding yourself as a patient accountable for understanding to the best of your ability what your treatment options are and making the best decision for you.”
Clinical research as a health care option
Byrne articulates the need for clinical research to become a health care option. “We have a moral, social and economic imperative that research participation becomes a choice among the options that people can contemplate for themselves and together with their support systems.” She explains, “It’s about bringing alignment among industry professionals and patients by answering key scientific questions in terms of pressing health care needs.”
What is good for the patient is also good for science and business. Across trials in multiple therapeutic areas, clinical research has yielded specific reductions in cost of care.2 Byrne provides an example: The average cost of health care for a patient is $9,400 annually and, for a type 2 diabetic, $13,700. During a 12-month trial, if that patient has a cost savings of $6,000 to $7,000, the impact on the health care system becomes far greater than a study budget.
Getz says that, because the pharma industry funds the majority of clinical trials, it is in a great position — especially as it collects more data that helps identify eligible investigators and patients — to drive clinical research into a clinical care environment and facilitate the clinician’s role as a support resource for clinical research activity.
Sharpe adds, “Clinical trials should be considered as a viable treatment option for any serious or chronic diagnosis, and patients should be involved in the treatment discussion from the beginning.” He also emphasizes the role of patient education in driving increased clinical research participation. “Collaboration between industry and advocacy has many benefits — in particular, the raised level of awareness on both sides of the trial experience,” he says.
1CMS.gov, National Health Expenditure Projections 2016–2025.
2PMG Research, Clinical Research Participation as a Care Option.
Joan Chambers, Senior Strategic Advisor, SCORR Marketing, is co-master of ceremonies at Bridging Clinical Research & Clinical Health Care Collaborative. Naomi Fujimoto is a senior copywriter at SCORR Marketing and for the Bridging Clinical Collaborative.
