Do I need a network of clinicians if I want to conduct a clinical trial?

It is rather beneficial to have a network with clinicians if you are involved in the field of medical devices and want to conduct clinical trials according to the MDR 2017 and the Medical Device Law Implementation Act. The necessity depends on your needs.

Arguments for working with clinicians:

1. expert knowledge: Clinicians have expertise in the medical field, know guidelines, are aware of unmet medical needs and often conduct research themselves. They are crucial for the planning and implementation of clinical trials. During and after implementation, these experts continue to ensure that communication is conveyed to healthcare professionals and that arguments are put forward to health insurance companies.

2. patient access: clinicians have access to patients and can therefore assist in the recruitment of study participants, which is important for a successful clinical trial.

3. ethical competence: clinicians understand the ethical aspects of clinical trials and can help ensure that trials meet the highest ethical standards.

4. contacts with authorities: clinicians often have experience in dealing with health authorities and can provide support in communicating and handling regulatory requirements.

5. practical experience: clinicians have experience in patient care and understand the practical aspects of using medical devices.

6. integration of processes in the clinical facility: A precise understanding of the processes in the medical facilities is essential in order to be able to conduct a clinical trial together with medical colleagues and other service providers. Discussions must take place at a very early stage and every effort must be made to ensure that the clinical trial is successful.

Arguments against working with clinicians:

1. time constraints: Clinicians often have limited time resources due to their clinical commitments, which could negatively impact their availability to participate fully in clinical trials.

2. bias and conflicts of interest: clinicians may be biased due to their direct involvement in other scientific endeavors or other roles as consultants, which could affect the objective assessment of the clinical trial.

3. skills shortage: In some cases, there may be challenges with the availability of qualified clinicians.

4. specialized studies: certain medical devices may require specialized clinical experts who are not always easy to find.

5. processes in clinical facilities: Often and increasingly, processes (or lack thereof) in clinical facilities stand in the way of the implementation of clinical trial processes.

A network with clinicians is very useful in order to obtain a meaningful study, especially in the planning and interpretation of the results, and to improve its chances of success. The advantages also clearly outweigh the disadvantages in conducting clinical trials, and every effort should be made to relieve the staff in the clinical facilities of the routine work and offer every support. This promotes collaboration, expertise and better integration into the clinical research area. Prior collaboration also accelerates market entry and presence later on.

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