GCP, Good Clinical Practice – Good Clinical Practice According to ICH E6 (R2) and ISO 14155

Good Clinical Practice – GCP – Good Clinical Practice

Another term related to GxP. But what’s behind it? Good Clinical Practice (GCP) is based on internationally recognized ethical and scientific standards in the field of clinical trials.

It provides a uniform framework for all steps from planning, execution, 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. Currently, ICH E6 (R2) is valid, and further updates are being worked on.

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 wish to conduct a clinical study, Good Clinical Practice requires you to clearly state the reasons for the study’s necessity. This is to prevent unnecessary studies from being conducted and subjects from being burdened. Whether this justification is sufficient is, for example, reviewed by an ethics committee.

During this review, in almost all cases, there are queries or suggestions for improvement regarding the submitted documents (these contain much more than the aforementioned justification). According to inquiries with various ethics committees, this is not related to your choice of an unsuitable CRO (Clinical Research Organisation).

GCP and MDR

The approvals of many medical devices under 93/42/EEC (MDD) were based on an equivalence demonstration within the framework of clinical evaluation. No clinical study was conducted with the manufacturer’s own product; instead, existing study data of the equivalent product were used. As the MDR now renders the equivalence route unusable in most cases due to stricter requirements, many manufacturers or products are left without their own clinical data. Although there is MDCG 2020-6, which describes a possible path for legacy devices under the MDR with limited clinical data, in many cases, the data situation becomes too thin, and clinical studies are suddenly necessary after all.

Within the validity period of the MDD certificates, a study should then be started in good time: The duration from planning to study completion can easily be 6 – 12 months, depending on the scope and product. Additionally, notified bodies have a processing time for MDR applications of 9 – 12 months. While we have experienced that clinical data could be submitted later after discussions with the notified body to save time, a significant time investment remains, and the loss of the MDD certificate without a new MDR certificate can quickly lead to substantial revenue losses.

How Can Thinqbetter Support in the Area of GCP?

We work closely with a partner company from Ukraine. This study partner handles all aspects of the clinical study, from planning, application to authorities and ethics committees, to execution and documentation.

For many years, our study partner has collaborated with various well-known companies from the pharmaceutical, medical technology, and IVD industries. We decided to collaborate due to the combination of incredible experience in conducting various studies and the attractiveness of Ukraine as a study location.

Why Conduct Studies in Ukraine?

To enable studies to be conducted as quickly and cost-effectively as possible, with the highest data quality, a location is needed where subjects are highly willing to participate in studies. Additionally, a location is needed where labor costs are lower than in one’s own country. And at the same time, the legislation must allow the data generated in the study to actually be used in the EU.

Our study partner can cover all these aspects and offers the most convenient and cost-effective way to generate clinical data that we have found so far.

Would You like to Learn more? Feel free to contact us!