A key step in the translational medicine “bench-top to bedside” process model is the move from research and preclinical (in vivo or in vitro) testing to a first-in-human (FIH). The purpose of conducting an FIH study is to determine preliminary safety and efficacy of the device and/or the response to the human body to the therapy. Data gathered and analyzed in FIH studies increase the efficiency of the device development process, since these data may lead to modifications to the device, procedure, training, patient selection, and/or clinical study methodology, which in turn will inform future feasibility studies and eventually, the statistically validated CE mark and/or pivotal study. Typically US-based companies choose to conduct FIH studies in EU member countries because the approval process there is fairly straightforward compared to the process and timeline for studies in the US. Three critical selections that need to be made by the sponsor company for successfully managing a FIH in Europe are: selecting a European Authorized Representative, selecting study site(s) and selecting principal investigator(s).
Choosing an Authorized Representative with appropriate qualifications and expertise is critical to effectively bridge communication among parties-including your Investigator, local ethics committee, and reviewing Competent Authority as he/she is speaking on behalf of the sponsor company. The Authorized Representative must therefore be fluent in EU standards, ISO and ICH guidelines relating to clinical research and local governing laws.
Careful consideration must also be given to selecting an optimal country and site to conduct the study. Sponsor companies should weigh submission requirements, approval time, contract process, country-specific requirements, budget and insurance requirements to properly select investigational site(s).
In parallel to selecting a country, a sponsor company needs to select investigator(s). It is critical in FIH studies to choose an Investigator who is able to provide expert advice and guidance into the design of the clinical study and who also has technical expertise with your product and device. Constant communication and dialogue is required with the investigator(s) on the performance of the device/therapy to ensure the safety of the subjects in an FIH study. This investigator should be viewed as a long-term partner in that he/she will have initial experience with the product and will provide guidance and expert advice throughout the FIH study, as well as when a larger pivotal trial is launched.
Results from FIH studies could be identified as the most pivotal milestone in a product’s lifecycle, and thus taking the time to plan appropriately up front in addressing inherent challenges and executing the study in the right environment is paramount.
For more information about First-In-Human studies, please call 763-287-3830 or reach out to us at namsa.com/contact-us. You can also read more about this important this important step in the translational medicine process in our white paper, Developing a European First-in-Human Study: Three Key Decisions.