DIA Releases Results of Patient Engagement in Drug Development Study
Study finds that half of pharmaceutical and biotech companies surveyed are implementing patient-centric drug development initiatives; but measurement and success vary widely
*Release updated from the original posted on October 31, 2016.
DIA, the leading professional community and knowledge exchange for global health care product development, announced today the results of its new Study of Patient-Centric Initiatives in Drug Development. The DIA study, conducted in collaboration with researchers at the Tufts Center for the Study of Drug Development (Tufts CSDD), finds that half of pharmaceutical and biotech companies surveyed have implemented patient-centric initiatives in drug development and a similar percentage are piloting or planning to implement initiatives. Top implementation barriers cited include difficulty securing buy-in internally and the lack of authority to implement initiatives. The research team found it difficult to quantify the impact of various patient-centric initiatives as there is limited comparative data available.
The reported benefits include reduced screen failure rates, faster patient recruitment rates, improved subject retention rates, reduced numbers of protocol amendments, and a greater number of patient relevant endpoints. In the research, cost of study conduct, ease of study conduct, and reported impact were measured. Three patient-centric initiatives stand out for their low cost-high benefit and ease-of-implementation:
- Advocacy group support and involvement
- Patient Advisory Panels and Focus Groups
- Social media and online engagement
“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, PhD, Senior Vice President and Managing Director, DIA Americas.
The results of the new Patient-Centric Initiatives in Drug Development study are available at www.DIAglobal.org and include an executive summary, webinar, and detailed findings that provide insights on a wide range of initiatives. The study is designed to help all stakeholders in drug development to understand:
- The impact of patient-centric initiatives using Return on Engagement (ROE) metrics
- Real examples of measurable benefit to drug development from patient involvement
- Details of patient-centric initiatives and their adoption
- The implementation and management models for patient-centric initiatives
- The guidance and frameworks for patient-centric initiatives
“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,” says Barbara Lopez Kunz, Global Chief Executive, DIA. “Our insights in the health care 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.”
Next Steps: DIA is calling for expressions of interest and recommendations for follow-on research in the following focus areas:
- Impact. 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.
- Accuracy. 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.
- Harmonization. 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.
For expressions of interest and recommendations for follow-on research, please contact Debra.Michaels@DIAglobal.org.
Funding for this study was provided by seventeen pharmaceutical, biotechnology and contract services organizations.