Driven by the rise of the empowered patient, biopharmaceutical companies are under pressure to demonstrate more than ever that patient centricity is embedded into the everyday of their organisation. There is a need to transform engagement with healthcare professionals (HCPs) due to the changing nature of healthcare services and resources, and greater regulatory expectations to tackle the disparity in clinical trial access for better health equity. The industry must embrace a sea change in patient engagement practices to succeed in today’s world.
At the recent Patients as Partners Europe conference, Kate Moss, our lead Partner in Pharmaceuticals and Life Sciences, hosted a panel to understand how market leading organisations have overcome hurdles to embrace working in partnership with patients. This included a patient advocate for Multiple Myeloma; Karen Skinner, Chief Project & Portfolio Officer of medical research charity LifeArc; and Andy Benzie, Head of Patient Focused Development with GlaxoSmithKline (GSK).
We also asked attendees directly about how the biopharma industry can improve the way it partners with patients. Echoing throughout was a clear agreement that patients should be co-creators of programmes and clinical studies, but there is still some way to go before this vision is realised.
Attendees' six priorities for improving engagement
1. Engage earlier for better business impact
"Engage…as early as possible in the development lifecycle to understand patients’ needs and preferences to drive strategy and plans."
Early patient engagement is crucial in establishing genuine and effective partnerships. Having a thorough understanding of patients’ and caregivers’ experiences, challenges, needs and expectations has several benefits 1, such as:
- driving strategy,
- designing better clinical trial protocols and endpoints 2, 3,
- improving study materials and information,
- providing insight into clinical trial participation barriers, enabling biopharma to implement solutions to overcome such hurdles, particularly for diverse patient populations 4, and
- a better understanding of what to measure to assess impact.
When executed well, patient engagement can also increase the likelihood of a medicine being successfully brought to market 5. This relies on consistent and systematic engagement, which requires understanding and buy-in from across different functions across the medicine lifecycle.
Read how we transformed one pharmaceutical company’s global operations to shape consistent and effective ways of engaging with patients.
2. Industry needs to be educated on the value of patient experience
"[We need a] greater understanding of the value of patient insights - both for outcomes and for the company to encourage more patient and caregiver involvement."
The life sciences sector has been discussing patient centricity for some time, but the value of this work is not always well understood. Part of this may be due to the inherent difficulty in quantifying its Return on Investment (ROI).
As patients become more invested in their health, biopharma must shift its mindset. Patients are no longer simply ‘clients’ or ‘customers’ - they are active partners in their own care, making decisions with the support of their clinicians and others.
Take the opportunity to look again at your patient-centric ambitions and the mechanisms by which you are sharing insights internally and using them to drive decision-making. Bring together representatives from across the business – from all functions, teams, and levels – to provide support and generate opportunities to embed patient-centric practice across all strategies and plans.
3. Accountability is key
"Harmonization/expectation and accountability for industry to ensure patient voice [is] embedded across the life cycle of medicines development."
Regulatory bodies are increasingly recognising the value of patient and caregiver engagement in informing the development of clinical research. The Food and Drug Administration (FDA) in the US has established a Patient Engagement Collaborative (PEC) with the Clinical Trials Transformation Initiative (CTTI), to look at how patient experience can be included in the regulatory process6. Elsewhere, the European Medicines Agency (EMA) published an updated framework in 2022 setting out its roadmap to ensure the patient voice is included within its regulatory activities7. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has set out plans to develop “underlying guidelines and processes to expand patient engagement safely and ethically in our work”8.
This focus is to be applauded, but a gap remains: there is still no official requirement that patients must be involved in the design and development of clinical trials by these same national bodies. In the absence of mandatory regulations, consider developing your own process to ensure consistency in how you approach and engage with patients and caregivers, capture their insights and store them in an accessible database.
Ensure your vendors and other partners, such as Contract Research Organisations (CROs), follow similar objectives to promote seamless collaboration. And make sure there are methods to measure compliance and hold personnel accountable where necessary. Lead the way in championing patient involvement and, in turn, see the improvements it can make to your science.
4. Representation matters – biopharma must do more
"Start by implementing a representation strategy. One patient organisation does not represent all. Speak to [and] engage with independent patient experts like me."
The more diverse a clinical trial’s participants are, the greater real-world robustness its findings will hold. This, in turn, can minimise regulatory-related delays and ultimately benefit patients due to a greater understanding of a treatment’s safety profile and dosage.
Biopharma, regulatory bodies, payers and HCPs all acknowledge this. For example, both NHS England and the FDA have published recommendations to enhance patient diversity in clinical research9,10, but these are advisory and the sector has been slow to respond. In a recent analysis of 148 randomised control trials (RCTs) in the UK between April 2019 and March 2021, only 60% reported the ethnicity of participants11. This needs to change.
Translate your diversity ambitions into tangible action. Consider a strategy to promote greater engagement with diverse patient groups, which includes practical steps that enable strategic goals to be realised. Assign responsibilities to individuals and monitor progress to encourage accountability.
5. Make it easier for patients to find and understand clinical research
"Create ONE website, where all clinical trials are listed in plain language, so patients are empowered to inform themselves and...decide whether they want to participate in one."
Increasing the accessibility of information will make it easier for patients to understand the details of clinical research and tackle misconceptions. In the main, study materials are not always as clear as they could be, which may hinder eligible people from enrolling in clinical trials. Others may want the opportunity to participate, but do not know about any appropriate studies or where to go to find out about them.
But even once people are enrolled into a study, they are not always kept informed. Very few industry representatives at the conference, when asked, said they provide every clinical trial participant with their results. This needs addressing urgently.
A good starting point is clinicaltrials.gov. It may not be the most patient-friendly in terms of language or accessibility, but it is a public resource listing the majority of clinical trials in progress and their results. Encourage HCPs to use this resource to speak to their patients about possible studies they may wish to take part in and monitor their progression.
A review into the clinical trials landscape in the UK, conducted by Lord O’Shaugnessy in 2023, recommended a similar site for the UK to act as a single source of information for patients, HCPs, researchers, and trial sponsors. Targeted campaigns to pique public interest in clinical research was also recommended12 - consider how you can contribute to this movement.
Strengthening relationships through the economics of kindness
Echoing throughout the conference was a clear sector-wide call to strengthen relationships with patients and caregivers. Compassion and empathy in healthcare are widely associated with better care and health outcomes, greater treatment adherence, patient satisfaction and improved quality of life 13, 14, 15. Kindness is a central component to achieving this success. Listen to patients about what matters to them most and take action accordingly. This will earn you the trust of the patients you are working with, the esteem of HCPs, and ultimately:
- contribute to better patient care, information and access to new and groundbreaking therapies,
- improve the quality of science,
- drive a motivated and purposeful workforce, and
- deliver greater commercial success.
We call this the ‘economics of kindness’. Biopharma companies that view patients as equals, treat them well and always strive to do the right thing will reap the moral, ethical, and financial rewards.
How can Baringa help elevate your patient engagement?
Patient focus is an enterprise goal for biopharma companies and the value of engagement is evident. By working in true partnership with patients, caregivers and advocacy groups, the quality of your science and the care patients receive will be improved, and satisfaction will be higher. At a corporate level, the sense of purpose for staff will be amplified, resulting in a more motivated workforce that will drive commercial success.
With Baringa’s broad expertise, we work with biopharmaceutical companies to review and remodel their patient engagement to embrace patients and caregivers as co-creators.
1 Vat, L. E., Finlay, T., Jan Schuitmaker-Warnaar, T., Fahy, N., Robinson, P., Boudes, M., Diaz, A., Ferrer, E., Hivert, V., Purman, G., Kürzinger, M. L., Kroes, R. A., Hey, C., & Broerse, J. E. W. (2020). Evaluating the "return on patient engagement initiatives" in medicines research and development: A literature review. Health expectations : an international journal of public participation in health care and health policy, 23(1), 5–18. https://doi.org/10.1111/hex.12951
2 Engage with patients to improve your clinical trial design | NIHR. (last accessed August 2023). https://www.nihr.ac.uk/explore-nihr/industry/pecd.htm#:~:text=Some%20of%20the%20benefits%20that,Better%20participant%20retention
3 Mann, C., Chilcott, S., Plumb, K. et al. Reporting and appraising the context, process and impact of PPI on contributors, researchers and the trial during a randomised controlled trial - the 3D study. Res Involv Engagem 4, 15 (2018). https://doi.org/10.1186/s40900-018-0098-y
4 Falcon, R., Bridge, D. A., Currier, J., Squires, K., Hagins, D., Schaible, D., Ryan, R., Mrus, J., & GRACE Study Group (2011). Recruitment and retention of diverse populations in antiretroviral clinical trials: practical applications from the gender, race and clinical experience study. Journal of women's health (2002), 20(7), 1043–1050. https://doi.org/10.1089/jwh.2010.2504
5 Patient centric trials: getting patients involved in their trials. (2018). EIU Parexel. https://druginnovation.eiu.com/patient-centric-trials/
6 Office of the Commissioner. (2023). Patient engagement collaborative. U.S. Food And Drug Administration. https://www.fda.gov/patients/learn-about-fda-patient-engagement/patient-engagement-collaborative
7 Patients and consumers - European Medicines Agency. (2022). European Medicines Agency. https://www.ema.europa.eu/en/partners-networks/patients-consumers
8 Patient Involvement Strategy: One year on. (2023). GOV.UK. https://www.gov.uk/government/publications/patient-involvement-strategy-one-year-on/patient-involvement-strategy-one-year-on
9 Research, C. F. D. E. A. (2020). Enhancing the diversity of clinical trial populations — eligibility criteria, enrollment practices, and trial designs guidance for industry. U.S. Food And Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial
10 Collaborative, N. a. A. (2023). NHS Accelerated Access Collaborative » Increasing diversity in research participation: A good practice guide for engaging with underrepresented groups. https://www.england.nhs.uk/aac/publication/increasing-diversity-in-research-participation/
11 Randomised controlled trial participants: Diversity data report. (2022). NIHR. https://www.nihr.ac.uk/documents/randomised-controlled-trial-participants-diversity-data-report/31969
12 Commercial clinical trials in the UK: the Lord O’Shaughnessy review - final report. (2023). GOV.UK. https://www.gov.uk/government/publications/commercial-clinical-trials-in-the-uk-the-lord-oshaughnessy-review/commercial-clinical-trials-in-the-uk-the-lord-oshaughnessy-review-final-report
13 Nembhard, IM, David, G, Ezzeddine, I, Betts, D, Radin, J. A systematic review of research on empathy in health care. Health Serv Res. 2023; 58(2): 250-263. https://doi.org/10.1111/1475-6773.14016
14 Walsh, S., O’Neill, A., Hannigan, A. et al. Patient-rated physician empathy and patient satisfaction during pain clinic consultations. Ir J Med Sci 188, 1379–1384 (2019). https://doi.org/10.1007/s11845-019-01999-5
15 Malenfant, S., Jaggi, P., Hayden, K. A., & Sinclair, S. (2022). Compassion in healthcare: an updated scoping review of the literature. BMC palliative care, 21(1), 80. https://doi.org/10.1186/s12904-022-00942-3
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