Partnering with patients in all aspects of RWE generation is key to ensuring that the research Pfizer is conducting is relevant to patients and aligns with their unmet needs. RWE is generated from Real World Data (RWD) which is any information relating to patient health, experience or healthcare delivery that is collected outside of clinical trials1. RWD can be obtained from electronic health records, disease registries or wearable devices like smart watches.
RWE can be used to answer questions that cannot be adequately addressed by randomised controlled trials and affords the opportunity to explore longer term efficacy and safety of a given treatment intervention2. The importance of RWE is increasing. Regulatory bodies, such as the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have released guidance on how to utilise RWD to support regulatory decision making1.
Patient involvement has a significant impact on the design and delivery of clinical trials3. Developing more patient-centric study protocols with an aim to improve retention and recruitment rates has brought about many benefits, as shown by our collaboration with the National Institute for Health and Care Research (NIHR)4. We believe the same approach should be taken to RWE generation ensuring that research priorities and studies align with what patients actually need.
To achieve this, we partnered with Voice5 (an intergenerational community of the public and professionals), Newcastle University6 and the UK National Innovation Centre for Ageing7.
Our goals were:
To understand from patients and carers what Real World Data and Evidence meant to them.
To develop a framework that will guide Pfizer colleagues on how best to partner with patients and carers in the design and development of RWD studies8.
We ran a series of eight workshops with a panel of 12 Voice members, all from different backgrounds. These patients and carers were not just participants in the process, but equal partners. By actively listening to them, we were able to integrate their insights during the co-creation of the practical framework for patient involvement in the design of RWD studies.
In 2023, this collaboration was recognised by the Patient Partnership Index – an award scheme run by Ovid Health - for its impact on the individuals involved and for showcasing excellence in industry-patient partnerships9.
Watch the videos below to hear the patients and carers describe their experience partnering with us to improve how we carry out our research:
This video displays patients and carers who are part of the RWD Panel sharing their experiences working with Pfizer to co-create resources for meaningful involvement in Pfizer RWD studies.
This video highlights the importance of partnering with patients and carers in Real World Data studies and why it makes a difference.
This video includes patients and carers sharing their experiences about why they should get involved in RWD studies.
PARTNERSHIPS
Scientific advances in medicine development are increasingly influenced by engagement with patient populations.
PARTNERSHIPS
We believe that, together, we can tackle some of the challenges facing the NHS today.
References
GOV UK. MHRA guidance on the use of real-world data in clinical studies to support regulatory decisions. Last accessed June 2024.
EvidentIQ. How Clinical Trials and Real-World Evidence Shape Healthcare. Last accessed June 2024.
Geißler et al. Patient involvement in clinical trials. Published July 2022.
NIHR. Translating intention into action - Piloting the NIHR Patient Engagement in Clinical Development Service. Last accessed June 2024.
Voice. About us. Last accessed June 2024.
Newcastle University. Who We Are. Last accessed June 2024.
National Innovation Centre Ageing. Who We Are. Last accessed June 2024.
Campbell Burton et al. Building a Practical Strategy and Framework for Diverse and Inclusive Involvement of Patients and Carers in Real World Data & Evidence Generation. Published December 2022.
Patient Partnership Index. Excellence in industry-patient partnerships recognised in fourth annual Patient Partnership Index. Last Accessed June 2024.