Clinical trial with combination product and medical devices

ICON provided regulatory support for a study to develop a novel treatment for patients using an implantable combination product and three separate medical devices. The study involved EU and non-EU countries with the objective to evaluate the therapy’s safety, tolerability and efficacy. It is expected to run for three years and three months.

There were several elements to the study:

• Combination product consisting of a treatment encapsulated and filled in a non-CE marked medical device
• Three additional non-CE-marked medical devices supporting implantation and extraction of the combination product
• The combination device was surgically implanted in patients in the preperitoneal site. The aim was to administer the IMP and support the maintenance of stable metabolic outcome

With site locations in both EU and non-EU countries, different regulatory processes were involved. The various combination products and medical devices used during the study added further complications. Timelines for the study start up were ambitious to achieve while ensuring that the quality of the documentation was not compromised. ICON’s regulatory team received complex queries from the various regulatory authorities at different points during the submissions processes.

CON built a robust regulatory strategy for the study which considered the complicated country requirements and processes. The experienced regulatory team engaged at both global and national level before confirming the study’s legislative pathway.

To avoid potential delays with study start up, the team clarified the country-specific requirements of the various regulatory agencies. They consulted with the agencies in advance to agree on the most appropriate way to process the study applications,

Once the regulatory pathway was mapped, the strategy and timelines were approved by the client. Our team created a list of the required documents, along with necessary translations. The client agreed on the roles and responsibilities for document preparation and implementing the processes for the regulatory strategy. This ensured that all requirements were identified at the outset so that there were no package elements missing. Thus, any potential queries would relate to the content of the study documentation rather than seeking missing elements.

The regulatory strategy was followed with the expectation that there would be multiple rounds of questions from each country due to the study’s complexity. The sponsor agreed with ICON’s advice to create country-specific versions of documents to minimize potential impact on study activation. The documentation was harmonised across the countries after initial approvals. This ensured that the study data was reliable and the content of the documentation could be navigated easily on a global level.

Study approval was received from all of the regulatory authorities and ethics committees without any unanticipated delays. As importantly, the first patients received the study treatment without pausing the study for safety concerns. Collaboration between ICON and the sponsor resulted in achieving milestones, progressing both the study and product development.

Note: Case studies extracted from whitepaper entitled: Demystifying EU Regulations on Clinical Trials: A blueprint for EU CTR, MDR and IVDR submissions