Patient-centric R&D: Analysis of feedback from 2,000 patient groups worldwide, 2017-2018
PATIENTVIEW PRESS RELEASE: 11th DECEMBER 2018
email: REPORT@PATIENT-VIEW.COM; Tel/cell:+44-7960-855-019
HOW TO BE PATIENT-CENTRIC IN DRUG R&D
2,000 patient groups worldwide, and their call to action
This is the second of two 2018 PatientView supplements that focus on pharma's patient engagement in R&D. Both supplements are intended to be used in conjunction with PatientView's evidence-based Being Patient-Centric toolkit (published November 2017), which identified nine key attributes of patient centricity. Pharma's success at one of the nine, however—engaging patients in R&D—has consistently been rated as unimpressive by patient groups. For example, PatientView's 2017 Corporate Reputation of Pharma survey (results published April 2018) found that 59% of the 1,300 respondent patient groups thought pharma just "Fair" to "Poor" at engaging patients/patient groups in product research; and 60% thought the same for pharma's record at engaging patients/patient groups in product development.
Table: The types of relationships that patient groups have with pharmaceutical companies, 2017. Number and percentage of respondent patient groups worldwide that worked with a company; N = 1,330
Worldwide, only 13% of patient groups responding to PatientView’s 2017 Corporate Reputation of Pharma survey said that they worked with pharma companies on clinical research, and only 12% said that they worked with pharma on clinical trials.
Patient-centric drug R&D: an area in need of improvement
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. This activity has led to two, new, in-depth supplements to the original November 2017 Being Patient-Centric toolkit:
A US-based supplement (published November 2018); and ...
- A Global-wide supplement (published today, 11th December 2018).
Both supplements provide companies with evidence-based strategy on the topic of patient-centric drug R&D.
THIS DECEMBER 2018 SUPPLEMENT CONSIDERS THE VIEWS OF 2,000 PATIENT GROUPS WORLDWIDE ON THE SUBJECT OF PATIENT-CENTRICITY IN DRUG R&D
This global supplement:
(1) Looks at the challenges across the lifecycle of drug R&D, from beginning to end–not only from an evidential perspective, but also through the words of patient groups themselves (with a comprehensive appendix of direct quotes).
(2) Contains a case study of the experience of one patient group, the New York-based Barth Syndrome Foundation (BSF), in running an externally-led meeting through the US FDA's Patient Focused Drug Development initiative.
(3) Re-configures the words of the patient community into a revised and up-dated toolkit of 128 'prompt' questions, aimed at allowing pharma companies to test the authenticity of their patient-centric R&D strategies. The supplement's revised patient-centricity toolkit acts as a guide toward further action plans for pharma.
(4) Features as case studies the initiatives taken by nine pharma companies to incorporate patients/patient groups into their company R&D activities (the nine companies conveyed these case studies to PatientView December 2017-March 2018, as part of the 2017 Corporate Reputation of Pharma survey).
WHY PATIENT-CENTRIC DRUG R&D IS SO IMPORTANT TO PHARMA COMPANIES–AND WHY IT IS ALSO SO CHALLENGING TO DELIVER
The pharmaceutical industry has long considered its primary customers to be healthcare professionals. This historic approach to patient care has, in the past few years, been eroded by consumer expectation and online knowledge sharing among patients—leading to patients becoming ever more informed, confident, and empowered. Wider attitudinal shifts across entire healthcare systems are also forcing pharmaceutical companies to focus more on patients' needs. Regulations are opening up more patient involvement; payers and insurers are focusing more on patient involvement and choice; and even physicians are becoming more patient-centric. As a result, a new model is emerging—one that places patients (and their carers, family and personal supporters) at the heart of the pharmaceutical business. Such a shift is a gradual evolution, but still represents a significant challenge for the industry—which must seek to accommodate regulatory demands, shareholder interests, and broader societal challenges (such as a healthcare system’s ability to pay for new products).
One US cancer patient group comments on some of the challenges that face pharmaceutical companies interested in patient-centric drug R&D:
“Every company is different. It depends upon the size of the company, their culture towards working with patient groups and patients, and how they engage in that way. Larger companies tend to have patient-advocacy staff or teams, but that often creates additional challenges to engage with other departments within the organization. Smaller biotech and pharma companies are more nimble, have fewer people to interact with, and can provide easier access to various staff, but also lack resources to support the patient organizations in ways that are mutually beneficial. Or, as the drug-development process moves through the cycle, the company is sold, or the compound is sold—both of which makes it challenging to maintain consistency throughout the entire drug-development cycle from a patient-leader perspective, as relationships must be developed over and over again.”
[Source of quote: PatientView August-October 2018 survey of 104 US patient groups on the subject of patient-centric drug R&D.]
SAMPLE QUESTIONS ON THE SUBJECT OF PATIENT-CENTRIC R&D FROM THIS DECEMBER 2018 BEING PATIENT-CENTRIC TOOLKIT
Note: The revised December 2018 toolkit of 128 prompt questions does not represent a consensus view among patient groups—rather, the range of views held by the 2,000 respondent patient groups.
R&D ACTIVITY
SAMPLE QUESTION [Total number of questions=128]
Determining patient unmet need from patient feedback
Do you have a process in place for each project, to identify and record the balance that patients require between the different attributes of a drug (for example, trade-offs between efficacy and side effects)?
Selecting therapy areas, patient populations and technology platforms
Depending on your portfolio focus, do you work effectively with patients from low-target populations (or their representative patient groups), such as: subgroups of mainstream therapy areas; children; or rare diseases?
Designing and conducting clinical trials
Do you have consistent and effective processes in place to ensure that each phase of a clinical trial is designed to build in patient engagement— and that it delivers this?
Building evidence for submission to regulatory authorities
Where regulators seek patient groups’ views as part of specific cross-stakeholder initiatives (such as the US FDA's Patient-Focused Drug Development/PFDD process), do you have an active strategy for participating with, and supporting, patient groups?
Attaining drug reimbursement
Within applicable regulation, do you provide training or support to build patient groups’ capacity, capability, or skills in engaging with policy-makers?
Collecting Real World Evidence
Within applicable regulation, do you provide training or support to build patient groups’ capacity, capability, or skills in engaging with policy-makers?
Managing mature products
Do you align with patient groups to ensure that brand, patent, and indication extensions take every opportunity to address identified unmet patients’ needs, preferences, and priorities?
This December 2018 toolkit is entitled Patient Engagement in R&D: Still a Challenge? The Opinions of Patient Groups Worldwide.
For further information about how to access the toolkit, please go to: http://www.patient-view.com/bull-being-patient-centric.html
... or email: report@patient-view.com