Recently, Sjaak Bloem and I had the privilege of presenting the BEAMER project to the Dutch CRO community during the annual Association of Contract Research Organization Netherlands (ACRON) symposium. The event, overseen by Prof. Dr. Carmen Dirksen of Maastricht University, centered around patient participation in clinical studies—a focal point that aligns closely with BEAMER’s overarching vision.

Image taken by Link2Trials
Aad Liefveld, image taken by Link2Trials.

Enhancing patient participation has been a core aspect of BEAMER’s mission, woven into the project’s framework. Beyond conducting extensive patient surveys, patients are active collaborators at every stage. Their involvement spans individual interactions through interviews and Delphi sessions, representation via project partners like APDP, AISM, and the World Duchenne Organization, as well as through our Patient Advisory Board.

Our fundamental belief is simple: genuine patient engagement begins with a comprehensive understanding of patients, a milestone we aim to achieve through BEAMER.

Particularly noteworthy were the presentations by Prof. Dr. Astrid Janssens from Utrecht University and Dr. Evelyn van der Aa of the Centrale Commissie Mensgebonden Onderzoek (CCMO), the governmental body responsible for reviewing and approving medical research involving human subjects.

Prof. Dr. Astrid Janssens eloquently advocated for the equal involvement of patients and caregivers in clinical research. Emphasizing equivalence is crucial, as it necessitates adjusted communication strategies. Often, there exists not only a knowledge gap between healthcare providers and patients/caregivers but also differing perceptions.

This discrepancy poses a risk of losing valuable insights during communication. Notably, she highlighted the role of caregivers—an often-overlooked aspect in discussions centered solely on patient participation. Drawing from her involvement in a UK study, she emphasized the vital information caregivers can provide and their need for support during a patient’s treatment journey.

As part of their patient participation initiative, CCMO is formulating new guidelines and regulations to bolster the role of patients in designing and executing clinical study protocols. While patient participation isn’t currently mandatory, CCMO is progressing towards full integration into studies in the Netherlands. Effective 1st March 2023, studies in the Netherlands must substantiate their inclusion or exclusion of patient participation. Full integration promises numerous benefits: patients gain clearer study information, contribute to protocol alignment, and receive regular updates on study progress and outcomes. For research organisations, this integration streamlines protocol approvals and grant acquisition, facilitating patient inclusion and retention while reducing research costs and delays—ultimately benefitting society by aligning research outcomes with real-world needs.

As Bob Dylan famously sang, “The times they are a-changin’,” and indeed, patients’ and caregivers’ roles in clinical studies are evolving. Their insights, needs, and challenges will reshape the landscape of clinical research, necessitating enhanced support—an area where BEAMER stands poised to offer expertise, knowledge, and guidelines to drive this transformation into reality. The information shared by Sjaak and me about BEAMER and the SHE model garnered keen interest, sparking numerous inquiries about real-world implementation. ACRON eagerly anticipates our further insights at their upcoming annual symposium.

About the author:

Aad R. Liefveld, Link2Trials, (BEAMER’s Work Package 1 Co-Lead)

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