DIA, a professional community and knowledge exchange for global healthcare product development, announced results of its Study of Patient-Centric Initiatives in Drug Development, reporting that the majority of pharmaceutical and biotech companies surveys have adopted patient-centric initiatives in drug development.
The DIA study, conducted in partnership with Tufts University, found that 65% of pharmaceutical and biotech companies surveyed have budgeted and are investing in patient-centric initiatives in drug development. However, barriers such as risk tolerance, lack of staff, time, and budget have constrained implementation. Furthermore, quantifying results is challenging as there is limited comparative analytic data that support specific methods of patient-centricity.
The good news is that lower cost patient-centric initiatives are benefiting drug development. Reported benefits include reduced screen failure rates, faster patient recruitment, improved subject retention, reduced protocol amendments, and a greater number of patient relevant endpoints. In the study, cost of study conduct, ease of study conduct and reported impact were measured. The four standout patient-centric initiatives against these measurements were:
Advocacy group support and involvement
Patient Advisory Panels and Focus Groups
Social media and online engagement
Patient counseling and education
Notable insights from the study include improved study performance and study volunteer feedback as a result of engaging Patient Advocacy Groups in these four ways.
“Almost all stakeholders agree that engaging patients in the drug development process is valuable, but the DIA study reveals that they do not necessarily agree on why or how,” commented Sudip Parikh, Ph.D., senior vice president and managing director, DIA Americas.
“The purpose of medicines is to improve patients’ lives; therefore, patients should be at the center of the drug development life cycle. For over 15 years, DIA has led the way in recognizing the value of patient involvement in health care product development, and today the patient community is intimately woven into all aspects of our thought leadership and our global strategic plan,” said Barbara Lopez Kunz, global chief executive, DIA. “Our insights in the healthcare ecosystem and our ability to convene the broad stakeholder community, including patients, provides a unique advantage in identifying new ways to engage patients in health care product development and to catalyze action.”
DIA is calling for expressions of interest and recommendations for follow-on research in the following focus areas:
Identify where in the drug development life cycle patient involvement is most impactful on company, disease, and patient population characteristics, to produce validated metrics and optimal conditions for patient-centric initiatives impact.
Apply the defined set of patient-centric initiatives metrics and complete a broader study of current and future patient-centric initiatives to produce a tested and validated metrics toolkit for industry.
Based on patient-centric initiatives insights, DIA will identify and clarify the top three to five patient-centric initiative areas and shape guidance development in advance of and in parallel with PDUFA VI.
