A brand new evidence-based toolkit to support pharma companies (and others) to be patient-centric

"The new November 2017 self-evaluation toolkit explores the most practical and comprehensive approach I have ever observed across the existing assessment frameworks for patient-centric programmes and initiatives. Every aspect must be taken into consideration when analysing what a company does to address unmet patient needs, hopes and expectations delivering real value. The industry, patients and community still have a challenge of inconsistency and absence of unified methodology clear for all and easily implementable by several stakeholders. I believe that the tool will help to identify any gaps/opportunities within engagement with patients as well as caregivers, advocates, activists and members of patient organisations; develop patient-centric strategy and address cross-stakeholder inconsistency."

Dr Oleksandr Gorbenko, ViiV Healthcare

THE PATIENT-CENTRIC TOOLKIT:

more information on the

BEING PATIENT-CENTRIC toolkit

Designed with the support of:

• 2,000 patient groups worldwide.
• Of 50+ different medical specialties.
• From 100+ countries.
• With international, national, regional, or local geographic remits.

Patient groups describe 9 major attributes that contribute to the process of corporate patient-centricity;  Every one of the attributes is, in turn, shaped by numerous fundamental factors;  For each of the fundamental factors, patient-group comments received by PatientView were reframed in the November 2017 Being Patient-Centric toolkit as questions that the patient groups themselves might well pose to companies. Patient groups pose 139 questions to pharma companies that are seeking to be more patient-centric.

SUPPLEMENTS TO THE TOOLKIT:

more information on being patient-centric in R&D:
​ ​
(1) THE perspective OF patient groups worldwide

MORE INFORMATION ON BEING PATIENT CENTRIC IN R&D:
​
​(2) THE PERSPECTIVE OF US PATIENT GROUPS

TWO SUPPLEMENTS TO THE TOOLKIT FOCUSING ON PATIENT INVOLVEMENT IN R&D (ONE OF THE NINE ATTRIBUTES):

Pharma's poor performance at engaging patients/patient groups in R&D prompted PatientView to focus further surveys, research, and analysis on the subject during 2018. Both 2018 supplements to be used in conjunction with PatientView's evidence-based Being Patient-Centric toolkit (published November 2017),

Global perspective on patient/patient-group involvement in research, and in development 

• Summary of the current global situation in patient/patient-group engagement in pharma research, and pharma development.
  
• A description of what patient groups expect in terms of their engagement at each of the key stages of pharma R&D.
  • Determining patient unmet need from patient feedback
  • Selecting therapy areas, patient populations and technology platforms
  • Designing and conducting clinical trials
  • Building evidence for submission to regulatory authorities
  • Attaining drug reimbursement
  • Collecting Real World Evidence
  • Managing mature products
    
• A list of 128 ‘prompt’ questions posed by these patient groups—aimed at helping companies determine just how patient-centric they are at each of the key stages of research, and at the key stages of development.
• Plus … a 2018 case study of a patient group, as it attempts to be involved with drug R&D
  

Patient engagement in drug R&D: The views of 104 US patient groups on the roles of the FDA, pharma, and other healthcare stakeholders:
Since 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.104 US patient groups responded to an August-October 2018 PatientView US survey on four important topics:

• How patient groups define ‘patient-centric R&D’.
• The FDA’s Patient-Focused Drug Development (PFDD) initiative.
• Pharma’s performance at being patient centric in R&D. And …
• The role of ‘real-world’ evidence (RWE) versus that of clinical trials.
• The study’s 104 respondent US patient groups were self selecting. The majority are involved, one way or another, in R&D-oriented activities. Included is an Appendix analysing the feedback from all 104 respondent US patient groups—and, more specifically, the responses from the respondent US patient groups specialising in cancer, rare diseases, and neurological conditions.