Medhealth Review

The use of retrospective samples in performance testing of in vitro diagnostic medical devices. CRO experience, ethical and regulatory perspective

From the perspective of Regulation 2017/746 (IVDR), it is possible to include archival samples in the performance studies of in vitro diagnostic devices – this will be known as a retrospective study. For this article, archival samples should be understood as sample residues (so-called leftover samples, including plasma, serum, whole blood, and mucosal swabs) or information (e.g., test results) that were obtained from a patient as a part of routine laboratory diagnostics aimed at diagnosing a pathogen (viruses, bacteria) or determining other sample parameters (e.g., blood type).

The optimal solution is to collect and store samples with biological material in laboratories acting as biobanks, that meet the regulations arising from legal regulations and normative documents, which is a guarantee of high quality of stored biological material. It is also permissible and practiced to archive samples in hospital and commercial laboratories that are not strictly a biobank. Then, a stability study should be considered for the stored biological material to prove its wholesomeness for future use in conducting IVD medical device performance studies.

It is incumbent on the entity collecting and biobanking biological material to have documentation in the context of being able to offer the collected material to third parties – i.e., those conducting IVD medical device performance studies. These documents include patient consents. One of the key and mandatory documents is the consent to process the patient’s personal data. The content of this document will determine whether the sample archived by the biobanking entity can be offered to third parties for inclusion in conducting a performance study of IVD devices, or whether the biobanking entity itself planning to conduct such a performance study will be able to use it. The second important document, recommended according to Good Clinical Practice, is the patient’s consent to use the residue of their biological material to conduct an IVD medical device performance study.

A retrospective IVD study using biobanked residual samples from patient is a variant of a clinical performance study not included in the regulation of Article 58 of the IVDR. This means that the entity conducting the performance study is not always required to obtain a positive opinion from the ethics committee. However, according to Good Clinical Practice, it is recommended that the study design be consulted with the above mentioned institution. There is also no obligation to obtain the approval of the national component authority to conduct a performance study using archived biological material, however the component authority must be notified of the intention to conduct such a study.

A study using residual samples is highly advantageous due to the limited number of procedures required to obtain a study permit. This type of project is associated with minimal risk to study participants during the project. Participants are not involved in additional sampling and the performance study process itself. Using a biological sample repository also reduces the time it takes to conduct a project due to the lack of need to recruit patients for the study prospectively. In many cases, such as for seasonal viruses, using a repository of samples banked at the site greatly increases the feasibility assessment of the study and makes it possible to accomplish the study.

From the experience of a CRO company, collecting and using retrospective samples is crucial. This approach has numerous benefits for both the company and the clients. First, storing retrospective samples allows for flexible management of research resources, which increases project feasibility and reduces costs. In addition, biobanking of residual samples increases the accessibility of the research, allowing clients to re-analyze results. This is especially important in long-term research projects. Furthermore, storing samples that are challenging to collect, often due to their low occurrence, plays a pivotal role in expediting research. This is because researchers can access these samples directly form biobank, eliminating the need to search for patients with these conditions, thus significantly speeding up the research process. CRO companies, as well as, study sites make sure that archival samples are properly stored and managed, ensuring their security and availability. Biobanking residual samples is not only part of a business strategy, but also a contribution to research development and scientific progress.

By Wioletta Piotrowska, Clinical Trial Coordinator at Pure Clinical and Zuzanna Szymanek, Junior Clinical Project Administrator Pure Clinical

Wioletta Piotrowska: 

Clinical Trial Coordinator at Pure Clinical 
Graduated in Biology from the Warsaw School of Life Sciences and the University of Warsaw. She specializes in microbiology. Responsible for establishing cooperation with new clinical trial sites and coordinating IVD medical device performance studies in accordance with IVDR, GCP and Sponsor requirements.

Zuzanna Szymanek: 

Junior Clinical Project Administrator
Graduate of Sustainable Biotechnology at Aalborg University in Copenhagen and Biotechnology at the University of Warsaw. Provides necessary support to the team to ensure the smooth execution of performance studies. Responsible for proofreading, dispatching study materials and helping streamline processes and optimize efficiency.

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