Should patient organisations be involved in the design of clinical investigations?

The involvement of patient organisations in clinical investigations offers clear advantages, especially in terms of risk and cost reduction.

This is often not done for reasons of cost or time, but the advantages outweigh the disadvantages, particularly in the medium and long term, especially in the case of novel and innovative approaches and products

• Inclusion of the patient perspective: Patient organisations represent the interests of patients and bring their perspectives into the clinical investigation by ensuring that the needs and concerns of those affected are taken into account.
• Relevance of research: The involvement of patient organisations ensures that research is truly relevant and focuses on the aspects that are most important to patients. They often know from their own experience where the unmet medical need is greatest.
• Improved trial conduct: Patient organisations can help identify and overcome barriers to ensure that clinical investigations are conducted in an efficient and patient-friendly manner.
• Risk reduction: The involvement of patient organisations helps to identify potential risks and adverse events at an early stage, as patients can directly assess the potential use and effectiveness of a medical device.
• Cost reduction: By identifying patient-relevant content at an early stage, the involvement of patient organisations can help to design the study in such a way that patient-relevant aspects are taken into account at an early stage, leading to a higher retention rate, smaller case numbers, focused treatment, higher effect size or avoidance of later adjustments to medical devices.
• Recruitment of study participants: Patient organisations can help to facilitate the recruitment of study participants by identifying and informing potential participants.
• Trust and acceptance: Ultimately, working with patient organisations strengthens trust in clinical research and the corresponding product and promotes the acceptance of a new medical device in the patient community.

The involvement of patient organisations can therefore contribute significantly to risk and cost reduction. This collaboration promotes patient-centred research, which not only optimises the development process, but also strengthens patient confidence and safety.

Overall, the involvement of patient organisations helps to improve the quality and relevance of clinical investigations and ensure that patients' needs are adequately addressed. This ultimately leads to a medical device being developed in line with demand and later being optimised for the market.

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