Request for proposal and initiation of an ATMP trial

Gateway

The ATMP Center is a gateway for industry, academia, and investigators to get help and support for the implementation of ATMP in clinical trials. As clinical trials with ATMPs have special requirements for e.g., pharmacy reception, medicinal products handling and implementation, early contact should be made with the ATMP Center to avoid delaying the start of the trial.
Contact ATMP-centrum@skane.se

Request for proposal

The initial request for proposal for participation in a potential trial should go through Clinical Studies Sweden's service for trial requests, Feasibility Sweden External link.. The question will then be communicated to both the ATMP Center and to potential clinicians who will indicate whether they are able and interested in conducting the trial.

When a clinic has expressed interest in a trial, the responsible investigator should contact the ATMP Center at an early stage (before signing the contract) at ATMP-centrum@skane.se. This is important to avoid the risk of a potential delay in the conduct of the trial due to ambiguities in the flow of medicinal products, contractual issues, etc.

If a clinic receives a direct request

If a clinic receives a direct request for participation in an ATMP trial, the principal investigator should contact the ATMP Center at an early stage, as this type of investigational medicinal product often has specific requirements for implementation and handling.

Preparatory documents

If there is a clinical interest in participating in a trial, it must be assessed whether the trial is practically feasible at Skåne University Hospital. The basis for this assessment is provided via the ATMP Center's preparatory form, which includes the following information on the investigational medicinal product:

• How to manage the medicinal product handling
• If preparation of the medical product will be required
• Possible risk class/biosafety level
• Storage requirements

Clinical prioritization

Once the trial is deemed to be feasible, the relevant clinical site will prioritize the trial based on clinical relevance, capacity, and other existing trials. For some trials, there are also special Priority Review Boards that must give approval before starting.

Agreement and budget

A budget is prepared by the sponsor together with the clinic. It takes into account the resources of the clinics, any consumables, and external parties within Region Skåne that may need to participate in the trial. The ATMP Center can support the investigator and the clinic with budget items specific to ATMP trials.

Once the budget is approved by both parties, a contract is signed between the parties. The contract may include the principal agreement, supply agreements, quality agreements and/or contracts between companies within Region Skåne. The contract flow for the principal clinical trial agreement (CTA) is the same as for other clinical trials in Region Skåne, but subcontracts specific to ATMP trials, such as delivery and quality agreements, are administered via the ATMP Center.

Biosecurity

When applying to conduct a clinical trial of a genetically modified organism (GMO), the sponsor must also seek authorization for the deliberate release of the GMO into the environment. In Sweden, this application is submitted to the Swedish Medical Products Agency in parallel with the application for clinical trial authorization. If the medicinal product is also considered a genetically modified microorganism (GMM), the pharmacy function and the clinic must submit a notification of contained use to the Swedish Work Environment Authority at least 45 days before the first handling of the GMM medicinal product. Different types of notifications are needed depending on the risk class/biosafety level of the product and in rare cases a specific application may be needed.

Please contact the ATMP Center for GMM notifications

Prior to notification/application to the Swedish Work Environment Authority, the investigator or clinic should contact the ATMP Center. We are in contact with Region Skåne's Biosafety Committee and in dialog with the Swedish Work Environment Authority to be able to support these issues. The ATMP Center has ready-made templates for the application and provides support in assessing the risk class and the requirements of the clinical management process.

Medicinal product handling

The practical handling of the investigational medicinal product must be determined. This is done through the ATMP Center in cooperation with the Region Skåne Hospital Pharmacy. The process of receiving, storing and possibly preparing the investigational medicinal product must be established. Depending on whether the investigational medicinal product is, for example, cell- or vector-based, this flow is managed by different pharmacy partners.

Mock-run

Before starting the trial, a mock-run is often conducted to evaluate the process flows and identify any shortcomings before the start of the trial.