Engaging Patients in Medical Research projects: hurdles & opportunities

When we talk about patient engagement (PE) in medical research, we face many issues:

1. Policymakers have difficulties wearing the patient hat.
2. Researchers have difficulties in understanding the real need of patients. Most of all since they rely on data from patients to advance the understanding of diseases and develop new treatments. Patients have a great challenge in trusting on medical research data sharing.
3. Patients do not always understand the design of the clinical studies nor are they highly involved in the process.
4. Ethical advisory group revisions of the projects and concepts haven’t been standard.

Especially in paediatric clinical research, improving protocols and including patients as well as their supporting network’s views and needs are huge pitfalls.

Language, power and knowledge barriers have always existed and affected patient recruitment and study retention but also impacted the lack of confidence in authorities and in medical research as such.

Good news though! The past ten years we have seen a new wave in patient centred approaches in the medical research landscape.

Patient engagement is getting strongly embedded in all aspects of medical research. The topic pops up increasingly in peer reviewed journals which has been supporting the dynamic (see Figure 1).

More than ever the voice of patients and their supporting networks is heard and put forward in milestones for governmental strategies of clinical hospitals, pharmaceutical industry and public-private partnerships. ​ ​

Including patient centricity into projects will reduce the burden of the trials, increase efficacy in hospital processes and eliminate stigma. Indirectly it will save many lives since healthcare professionals, because of these benefits, could be getting the right medicine to the right patient faster, cutting time and cost for clinical trials and in the end provide better therapeutic drug development.

Until recently, the dominant culture was not patient centricity but rather a payer focus, a physician focus. Leaders in medical research are now responding to the world from a top down approach and deal with the heavy regulatory compliance.

Health technology assessment international (HTAi) has overviewed patient and citizen involvement in a recent eBulletin. They share with us the work of IMI projects PARADIGM and PREFER with “Short survey to Find Out Stakeholders’ Needs and Expectations for Patient Engagement in the Medicines Research and Development Lifecycle” but also work on a patient voice in drug development or patient preferences.

In the IMI project Conect4Children (C4C), 43 partners within Europe – including pharmaceutical companies – have formed a collaboration to create a functional pan-European infrastructure network for paediatric clinical research.

Patient networks and advocacy groups play a major role in driving the current momentum shift.

What is the best practice to involve patients into huge public-private partnerships?

An important recent study by Boudes et al., has tried to gain insights and alignment in patient engagement via a qualitative multi-stakeholder survey on their experiences.

Participants were grouped into 7 categories: policymakers/regulators; healthcare professionals (HCPs); research funders; payers/purchasers/HTA; patients/patient representatives; pharmaceutical/life sciences industry; and academic researchers.

Here are a few of the take-home messages from the article:

1. there is very often the lack of a “leader” in these collaborations;
2. no stakeholder has a clear view on how to meaningfully engage with patients
3. there are educational gaps
4. structure and guidance for PE is urgently required
5. need of multi-stakeholder collaborative leadership

Effective collaboration requires consensus on roles, responsibilities and expectations to synergize efforts to deliver meaningful patient engagement in medicines life cycle is put forward as the best solution.

“Be the change you would like to see in the world” M.G.

Modis Life Sciences is involved in several projects focusing on helping and involving patients directly or indirectly; either in vaccine development, paediatric clinical research or many other projects in medical research. Modis Life Sciences delivers Contract & Grant Project Management expertise to IMI_C4C and we fuel great value to leadership and multi-stakeholder collaborations in healthcare.

– Paul Peeters, Consultant 

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