Biomedical research has advanced healthcare to a place that would be unrecognisable just several decades ago. Clinical research, where patients volunteer to participate in clinical trials of new treatments, underpins this advancement. There’s a valuable opportunity to enhance the protection of trial participants, while also advancing more efficient and ethical methods for sharing health data. It is critical to empower trial participants, along with other stakeholders, such as policymakers, sponsors, clinicians and scientists, to participate in shared decision-making that can guide trials to fruitful outcomes, while maintaining ethical rigour and transparency. Read More
Towards this aim, Professor Johanna Blom and colleagues at the University of Modena and Reggio Emilia propose the creation of social alliances of relevant stakeholders to form the bedrock of participatory clinical research. Their goal is to build a trustworthy framework that improves ethics, safety, and transparency in clinical trials, helps participants make informed decisions and engages stakeholders to strengthen understanding of trial protocols.
Within a social alliance, stakeholders should pool their resources, expertise and capabilities, to navigate the ethical and technical challenges of clinical research. This could occur at both a higher level, such as national or international alliances that deal with issues affecting all clinical research, and on a trial-by-trial basis, where a social alliance could guide trial and data-sharing activities. It is important that all stakeholders are included to ensure that alliances are representative and effective.
Given that a social alliance would contain a diverse blend of people, from patients and scientists to clinicians, sponsors and policymakers, the researchers emphasise the importance of fostering mutual trust and respecting the unique perspective of each participant. The overarching goal should be to acknowledge the concerns of all participants, regardless of their differing backgrounds. Members of the alliance will have varying goals and values.
The team suggests that blending ideas like psychological safety with the emotional and cognitive aspects of decision-making can promote open dialogue. This open dialogue can help build mutual understanding and cooperative action. As a result, participants may become more engaged and trusting. This could lead to better compliance, more accurate data, and ultimately, more successful trial outcomes.
Blom and her colleagues sustain that the success of future clinical research depends on our ability to build and maintain strong relationships and anticipate that this type of shared decision-making can significantly enhance the experience of clinical trial participants during the trial and data life cycle.
This could also direct trials so that their outcomes benefit society as a whole, rather than specific interest groups. The moral compass that should underly clinical research is best referred to as collective, mutual, transparent and reciprocal, and social alliances represent an effective way to achieve this.
