Patient Involvement in Research and Development
Scientific advances in medicine development are increasingly influenced by engagement with patient populations.
Our purpose is to develop breakthroughs that change patients' lives and in order to do that we are focused on expanding the involvement of patients. patient organisations, carers and the general public in all stages of the drug discovery and development process.
Pfizer Patient Engagement Principles
Pfizer continues to seek to involve patients earlier and more systematically in the medicine development lifecycle. Patient involvement throughout this process means that we are developing medicines that better support patients' needs. To do this effectively, open principles of engagement are required.
The principles that guide Pfizer’s work with patients, carers, and patient organisations include:
- Mutual respect and independence
- Avoidance of actual or perceived conflicts of interest
- Transparency, in a manner that is consistent with applicable laws and regulations as well as Pfizer’s corporate values.
Pfizer has been actively engaging with patients and the broader community to help with R&D efforts for over a decade.
Pfizer's global patient partnerships range across the lifecycle of the R&D process, beginning in early discovery and continuing through medicine development, product registration, and beyond.
Pfizer's disease-area partnerships have been diverse and focused on different therapeutic areas including oncology, immunology and inflammatory diseases, and rare diseases.
Science and Technological Advances are Changing our Approach to R&D
Technology is equipping patients with real-time health data. The internet can help increase health literacy and connect patients with other patients. These, and other tools, can empower people to take control of their health while enhancing their ability to engage with the healthcare ecosystem. At the same time, the patient community has shown increasing empowerment, connectedness and sophistication.
The evolving ecosystem has enhanced the opportunity for researchers and clinical trial sponsors, such as Pfizer, to engage with patients, carers and patient organisations to better understand the characteristics necessary to address patients’ needs, wants, and expectations for new therapies. This is especially important as these therapies are increasingly developed to be targeted to patients, rather than diseases.
Patient engagement includes dialogue with patients, their carers and healthcare providers, as well as relevant stakeholders. Each of these communities brings a unique perspective. Early and continued engagement is providing important information and ensuring that patient priorities are addressed.
As subject matter experts for a specific disease or therapeutic area, patients reveal valuable perspectives and help to focus research and development programmes.
Other aspects of patient involvement in R&D may include:
- exploration of research questions focused on patient priorities;
- development of definitions of clinical benefit from the patient perspective;
- improved clinical trial recruitment and retention;
- study designs that include relevant patient-centered outcome assessments;
- more patient friendly informed consents and other documents;
- improved study design that avoids or reduces the need for potentially time-consuming protocol amendments;
- input to plain language summaries for dissemination of study results;
- developing patient-focused evidence of value that helps inform regulatory decision-making.
Pfizer’s Position in R&D
Patient involvement in R&D is a fundamental component of Pfizer’s commitment to advancing science, delivering needed therapies, and improving patient outcomes.
Pfizer engages in a variety of partnerships and initiatives, whose long-term goals include end-to-end integration of patient experiences and preferences throughout the R&D continuum, to product registration, and beyond.
A few examples of how Pfizer is engaging with patients are listed below:
- Setting the Research Agenda: Pfizer engages with patients and patient organisations across disease areas to develop research agendas, understand patient needs, and determine shared goals.
- Clinical Benefit: Pfizer recognises that the clinical benefit of the breakthroughs that we develop is incomplete without evidence that our medicines are meaningfully and favourably addressing outcomes that are priorities for patients. Pfizer’s Patient-Centered Outcomes Assessment function is dedicated to ensuring that clinical benefit is defined from the patient perspective by measuring what is meaningful to patients using patient centered outcomes assessment tools.
- Clinical Trial Input: Pfizer engages with members of patient organisations to gather their input on the feasibility and design of clinical trials, including on the development of protocols and endpoints, informed consent, and other clinical trial documents.
- Setting Industry Standards: Pfizer has collaborated with the National Institute for Health Research (NIHR) on the NIHR Patient Engagement in Clinical Development Service, a national way of working to ensure patients have the opportunity to help shape clinical research. This recognises patients as experts of their own conditions, and enables their voices to be heard more clearly and deeply, ultimately leading to better healthcare outcomes and more successful clinical trials.
- End of Study Information and Plain Language Summaries: Pfizer was the first biopharmaceutical company to return plain-language clinical trial data to patients, and we are working to expand our leadership in this area. Starting with all Phase II & Phase III studies that initiated in 2014, Pfizer will offer summaries of the trial findings to participants in easy-to-read, non-technical language, in countries where regulations will allow it. These summaries review why the study was done, how it was done, and the results. These “Plain Language Summaries” were first piloted in the US in 2009 with four studies, and they have been well-received by trial participants.
How Patients, Researchers, and the Health Care System Benefit
Patient engagement can help guide development of therapies and vaccines to meet the needs, priorities and preferences of patients and the broader community. Discussions with patients, carers and patient organisations that are based upon mutual respect and independence can facilitate the achievement of mutual goals.
This exchange of ideas can lead to better research and clinical trial design, more patient-relevant endpoints, improved recruitment for clinical research and more diverse patient population representation in clinical trials, which can help to achieve health equity and increase access to therapies.