Setting up clinical trials in smaller countries rather than established trial hubs can offer many advantages to sponsors including higher recruitment, potentially greater access, a more engaged investigator research staff, said Carine Cochereau, vice president of regulatory international at Integra Life Sciences.
Optimising clinical trials was a point of discussion at the ongoing Outsourcing in Clinical Trials: Medical Devices Europe 2024 conference in Munich, Germany on 30-31 January. Multiple approaches to achieve this optimisation such as using artificial intelligence and incorporating real-world data to bolster the regulatory submission were discussed on the first day of the conference.
In addition to listing various advantages of conducting clinical trials in the Asia-Pacific and Middle East region, Cochereau also outlined the challenges for doing the same. She stated that as these countries do not have established trial hubs they may lack the appropriate research support staff, and training may be required on trial practices and guidelines.
Along with the site-specific challenges, the country’s import laws, and regional political instability can also impact product availability. This was particularly apparent during the Russia-Ukraine conflict where multiple clinical trials had to be abandoned. At the beginning of the ongoing Israel-Hamas war, several global pharma companies operating in Israel had closed their businesses.
Whilst most clinical trials are conducted in the US and Europe, many Asian countries are now catching up by hosting several clinical trials. As per the GlobalData clinical trial database, Israel and China are part of the top 10 clinical trial locations for conducting trials evaluating diabetes care devices.
GlobalData is the parent company of Medical Device Network.
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Cochereau also noted that while there are some countries where you can use clinical trial data from trials conducted in other countries to support regulatory approval. For example, some countries such as Japan, China and Hong Kong require clinical trial data from the country’s patient population. This can, therefore, increase the cost of developing a product.
She also mentioned that some countries, including Canada, Australia, the US, and South Korea, offer innovation pathways which can aid in product development by enabling faster regulatory approval. In October 2023, The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) introduced a new system to speed up the approval processes for the lowest-risk clinical trials. The system aims to process initial applications for Phase III and IV low-risk trials will be processed within 14 days, instead of the usual 30 days.