Patient-centric R&D in the USA: results of a Fall-2018 survey No Images? Click here PATIENTVIEW PRESS RELEASE: 20TH NOV. 2018PATIENT ENGAGEMENT IN DRUG R&D: The views of 104 US patient groups on the roles of the FDA, pharma, and other healthcare stakeholdersThis is the first of two supplements focusing on patient engagement in R&D. Both supplements are intended to be used in conjunction with PatientView's evidence-based Being Patient-Centric toolkit (published Nov. 2017)This November 2018 supplement consists of: 1. A PDF report highlighting the findings of an August-October 2018 survey of US patient groups on patient-centric R&D; and 2. An accompanying 33-page Appendix analysing the many comments received from the respondent US patient groups. The supplement aims to be a guide to pharma strategy, and to inform regulators.
The FDA's ground-breaking PFDD initiative, bringing patients and patient groups into the heart of drug R&D, could be transformationalSince 2016, the Food and Drug Administration (FDA) has been actively promoting programmes which put patients at the heart of drug research and development (R&D), through its 'Patient Focused Drug Development' (PFDD) initiative. The PFDD initiative invites patients and patient groups to participate in the process of drug R&D from the onset, so that the output of pharma's R&D can better reflect patients' needs and concerns. Aside from the FDA-organised meetings, the federal agency has encouraged, and been involved in, external meetings arranged by patient groups in different therapy areas. Coming against the backdrop of a growing drive toward patient centricity in the pharma industry, the PFDD initiative could bring significant consequences in the way that future drug R&D is conducted—not only in the US, but elsewhere, too. Several international and Europe-based, multi-stakeholder consortia are also discussing how patients can be better engaged in R&D. The difference between them and the FDA's PFDD is that the latter is actually putting ideas into practice. About this US PFDD survey Because of the importance of the FDA’s PFDD initiative, and the heightened activity of US patient groups in drug R&D, PatientView decided to conduct a survey of patient groups in the US on the subject. The survey ran August-October 2018, and this report (and Appendix) contains the survey’s results. THE SURVEY, AND WHO ANSWERED
The study’s 104 respondent US patient groups were self selecting. The majority are involved, one way or another, in R&D-oriented activities.
WHAT US PATIENT GROUPS THINK ABOUT THE CURRENT STATE OF PATIENT ENGAGEMENT IN R&DFrom the feedback received, the vast majority of the US patient groups responding to the August-October 2018 US PFDD survey consider that activities undertaken during R&D should always incorporate the patient perspective, and 56% of the respondent US patient groups think that the main outcome of engagement should be R&D investment which truly addresses patients’ needs. The majority of US patient groups believe that the best definitions for effective patient engagement in R&D are:
But, most US patient groups also believe that much of their understanding of what makes effective patient engagement in R&D is NOT yet happening in the US. Only a minority of the respondent US patient groups believe that other healthcare stakeholders are willing to engage with patient groups on R&D activities.
How willing are the following stakeholders to engage with PATIENT GROUPS LIKE YOURS in all types of R&D? % answering “All are willing” or “Most are willing” Not surprisingly, then, 98% of the respondent US patient groups declare some sort of interest in the FDA's PFDD initiative (only 2% are not interested). Around one third of the US patient groups have already been involved with the FDA's PFDD initiative in some way. Almost 40% are interested, but not sure how to engage. Key concerns: Despite the tangible excitement among the patient/patient-group community about the possibility of interaction with drug R&D, many concerns about the FDA's PFDD are aired by respondent US patient groups (particularly those actively engaged in the FDA's PFDD). Above all, 65% of US patient groups worry that the PFDD processes will listen to patients’ opinions—but not act upon them. 56% of the US patient groups declare that they lack the resources for becoming involved in PFDD. HOW SHOULD PHARMA REACT?Over half of the respondent US patient groups state that they work in general with pharma to improve patient engagement in R&D. 28% of the US patient groups state that they have worked with pharma on the FDA’s PFDD initiative. But, clearly, from the many comments received from these organisations, pharma could significantly improve these types of relationships. The 104 US patient groups were asked to list three optimum ways in which pharma could be more effective at engaging patients and patient groups in R&D. The hundreds of comments were analysed and weighted on the frequency of mentions, to produce a 'wish list'. Patient groups also provide advice about how to attain the 10 goals. Most-important actions for pharma companies to take to effectively engage patients (and patient groups) in their R&D ... END OF PRESS RELEASE ... About the Being-Patient Centric supplements: The initial Being Patient Centric (BPC) toolkit was developed in 2017 by PatientView with the support of thousands of patient groups. The toolkit is intended to help pharmaceutical companies become more patient centric. BPC supplements expand on the core themes developed in the initial 2017 toolkit. An evidence-based approach lies at the heart of all of PatientView’s BPC publications. Supplements 1 and 2 (November 2018) both focus on the subject of patient centricity in R&D. The 2nd BPC supplement—a global overview of patient centricity in R&D—will be published in the next few weeks. |