GCP, Good Clinical Practice - according to ICH E6 (R2) and ISO 14155

Good Clinical Practice - GCP

Another term with GxP. But what is behind it? Good Clinical Practice (GCP) is based on internationally recognised ethical and scientific standards in the field of clinical studies.

This provides a uniform framework for all steps from planning, implementation and documentation to study completion. A detailed list of what is expected in the area of GCP is provided by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The first version of the ICH E6 Good Clinical Practice (GCP) Guideline was published in 1996. In the meantime, ICH E6 (R2) is valid, and work is currently underway on a further update.

In addition to the ICH Guideline, there is ISO 14155:2020, which specifies normative requirements for the clinical investigation of medical devices in humans. ISO 14155 thus directly addresses the topic of GCP and provides a comprehensive framework that is extremely helpful even in the early phase of study planning.

Similarly, for the conduct of clinical performance studies with IVDs, there is ISO 20916:2019, which describes good study practice.

GCP principles

If you want to conduct a clinical study, Good Clinical Practice requires that you clearly explain the reasons why the study is necessary. This is to prevent unnecessary studies from being conducted and subjects from being burdened. Whether this justification is sufficient is checked, for example, by an ethics committee.

In the course of this review, there are almost always queries or suggestions for improvement regarding the submitted documents (these contain much more than the previously mentioned justification). Incidentally, according to enquiries with different ethics committees, this is not related to the fact that you have decided to select an unsuitable CRO (Clinical Research Organisation).

GCP and MDR

The approvals of many medical devices under 93/42/EEC (MDD) were based on a proof of equivalence within the framework of the clinical evaluation. No clinical study was conducted with the own product, but the existing study data of the equivalent product was used. As a result of the fact that the MDR now makes the equivalence route unusable in most cases due to stricter requirements, many manufacturers or products are left without their own clinical data. There is MDCG 2020-6, which describes a possible route for legacy devices under the MDR with little clinical data. However, in many cases the data situation becomes too thin and clinical studies are suddenly necessary.

Within the validity period of the MDD certificates, the implementation of a study should then be started in good time: The duration from planning to study completion can be a good 6 - 12 months. Depending on the scope and product. In addition, notified bodies have a processing time for MDR applications of 9 - 12 months. We have made the experience that after discussions with the notified body, clinical data were allowed to be submitted later in order to save time. However, a large amount of time remains and the loss of the MDD certificate without a new MDR certificate can quickly lead to a large loss of sales.

How can thinqbetter support in the area of GCP?

We work closely with a CRO for conducting all kinds of clincial studies / investigations. This partner takes care of all aspects of the clinical stduy, from planning, application to the authorities and ethics committee, implementation and documentation.

For many years, our study partner has been working with various well-known companies from the pharmaceutical, medical technology and IVD sectors. Due to the combination of incredible experience in conducting various studies and the attractiveness of Ukraine as a study location, we decided to cooperate with them.

Optimal locations

In order to make studies possible as quickly, cost-effectively and with the highest data quality as possible, you need a location where subjects have a high willingness to participate in studies. In addition, you need a location where labour costs are lower than at your own site. And at the same time, the legislation must be such that the data generated in the study can actually be used in the EU.

Our study partner can cover all these aspects, locations and offers the most convenient and cheapest way of generating clinical data that we have been able to find so far.

Would you like to learn more? Then feel free to contact us!