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

It is more beneficial to have a network with clinicians if you are involved in the medical device field and want to conduct clinical investigations with medical devices.

Whether it is necessary beyond that depends on your needs. The following reasons are intended to shed light on this consideration.

Arguments in favour of 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 investigations. During and after implementation, these experts continue to ensure that communication is communicated to the professional community and argued to health insurance companies.
2. Patient access: Clinicians have access to patients and can therefore help with the recruitment of study participants, which is important for a successful clinical investigation.
3. Ethical expertise: Clinicians understand the ethical aspects of clinical investigations and can help ensure that studies meet the highest ethical standards.
4. Regulatory liaison: Clinicians often have experience in dealing with health authorities and can assist in communicating and managing 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 facility is essential in order to be able to conduct a clinical investigation 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 investigation 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 fully participate in clinical investigations.
2. Bias and conflicts of interest: Clinicians may be biased due to their direct involvement in other scientific endeavours or additional roles as consultants, which could affect the objective assessment of the clinical investigation.
3. Skills shortage: In some cases, there may be challenges with the availability of qualified clinicians.
4. Specialised studies: Certain medical devices may require specialised clinical experts that 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 conducting clinical investigations.

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 when conducting clinical investigations, and every effort should be made to relieve the burden of routine work on clinical centre staff and offer every support. This promotes collaboration, expertise and better integration into the clinical research area. Prior collaboration also accelerates later market entry and presence.

For more information or an initial non-binding discussion , please contact us.