Should patient organizations be involved?

Yes, the involvement of patient organizations in clinical trials in accordance with the MDR2017 and the Medical Device Law Implementation Act offers clear advantages, especially with regard to risk and cost reduction. Here are reasons to do so:

1. Patient perspective:

- Patient organizations represent the interests of patients and bring valuable perspectives to clinical trials by ensuring that the needs and concerns of those affected are taken into account.

2. Relevance of the research:

- The involvement of patient organizations ensures that the research is truly relevant and focuses on the aspects that are most important to patients.

3. Comprehensibility of the information:

- By working with patient organizations, information on clinical trials can be provided in a way that patients can understand.

4. Improved study execution:

- Patient organizations can help identify and overcome barriers to ensure that clinical trials are conducted in an efficient and patient-friendly manner.

5. Risk reduction:

- The involvement of patient organizations helps to identify potential risks and adverse events at an early stage, as patients have a unique perspective on the tolerability and efficacy of a medical device.

6. Cost reduction:

- By identifying patient-relevant content at an early stage, the involvement of patient organizations 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.

7. Recruitment of study participants:

- Patient organizations can help facilitate the recruitment of study participants by identifying and informing potential participants.

8. Trust and acceptance:

- Cooperation with patient organizations strengthens trust in clinical research and promotes the acceptance of new medical products in the patient community.

The involvement of patient organizations therefore not only brings ethical advantages, but can also contribute significantly to risk and cost reduction. This collaboration promotes patient-centered research, which not only optimizes the development process, but also strengthens patient confidence and safety.

Overall, the involvement of patient organizations helps to improve the quality and relevance of clinical trials and to ensure that patients' needs are adequately considered.