By Ames Gross, President and Founder of Pacific Bridge Medical
This blog post was also published on MedTech Intelligence.
International medical device companies are increasingly required to conduct local clinical trials for medical device approval in Asia. However, finding, qualifying, and selecting the right contract research organization (CRO) in this region can be a challenging process.
About ten years ago, I was working with a small U.S. device company that wanted to sell their device in Japan. At the time, they had about $25 million in global sales, 90% of which came from the United States. However, a Japanese trading company saw a big opportunity in the device company’s technology and invested $5 million in the company. In exchange for making this investment, the Japanese trading company demanded exclusive distribution rights of their product in Japan for five years, and also required that the product be distributed and registered via their subsidiary medical device distributor. Since the U.S. device company was eager to get the $5 million investment, they did not perform adequate due diligence on the Japanese trading company or their medical device distributor subsidiary.
Since the Japanese distributor was in charge of product registration, this meant that they were responsible for local clinical trials in Japan. Unfortunately, this distributor did not have much experience conducting or managing device clinical trials. After the clinical trials were completed, the Pharmaceuticals and Medical Devices Agency (PMDA) decided that they were not adequate for product approval in Japan. Given this scenario, the device was never registered and significant sales were not realized in the Japanese market. It took another 10 years for the U.S. device company to get the product registered and start sales.
As shown from this experience, device executives need to be very careful when choosing a CRO to conduct device clinical studies in Japan. While a number of the large global CROs are present in the country, a number of more local Japanese CROs are available as well. Most Japanese CROs specialize in different product areas, and it is very important to match the Japanese CRO’s experience with the product area for your local clinical trials.
Like with everything in Japan, the cost to conduct clinical trials is quite high. Oftentimes, Western executives fail to consider this when they are developing a regulatory strategy for Japan. For example, a mid-sized U.S. device company recently asked me to get them several quotes from Japanese CROs to conduct two clinical studies there. The CRO quotes for one of the trials amounted to approximately $1.5 million, and the other $2.5 million. The device company decided not to proceed. The cost for doing clinical trials in Japan was more than five times what they had anticipated.
Of course, the cost of the clinical trial should always be weighed against the market opportunity. If in five years the market opportunity for the product is $20 million in sales, investing several million dollars now to do the local clinical studies may still make sense.
Choosing CROs in China can also be an interesting experience. Again, there are large global CROs as well as local CROs. Historically, most CROs in China only conducted clinical trials on drugs and not on medical devices. Today, since regulations have changed: Registering a Class II or III device in China normally requires local clinical studies, so both global and local CROs are undertaking more device trials. A number of these CROs have had mixed success.
Recently, the China Food and Drug Administration (CFDA) launched a series of acts to enhance the quality and integrity of clinical studies done on drugs in China. The CFDA has asked pharmaceutical companies to voluntarily withdraw submitted dossiers or already approved products if the company believes that the clinical data in their dossier is not “clean”. The agency is also randomly choosing and investigating past drugs that were approved, along with the clinical studies that were done for those approvals. It is amazing how many clinical trials were revealed to have submitted fake or altered data. Then again, this is China.
So far, the CFDA has identified a few companies and listed the outcomes of their investigations on a so-called “blacklist.” This published list includes the drug name, formulation, CRO, and the sites where the clinical trials were conducted. The CFDA has also listed clinical trials that were done in the past that they no longer find acceptable. While this trend has not begun for medical device clinical trials in China, it likely is not far behind.
In India, most medical devices do not require local clinical studies for approval, as only a number of device products are currently regulated in India. High-risk devices that require clinical studies have been approved primarily using foreign clinical data. And some high-risk devices that were already approved in India now require post-market surveillance studies for product renewal.
However, on the drug side of clinical trials in India, there have been significant problems. Many Indian CROs conducting drug trials have used Indian patients as guinea pigs. Oftentimes, the patients in the clinical studies have not signed informed consent forms, nor are they aware of the likelihood of the many possible adverse effects. Due to these serious issues, the Indian CRO business for drugs has declined more than 90% over the last few years.
It is crucial to perform extensive due diligence on Asian CROs to ensure that they have the expertise for your specific medical product as well as the capability and integrity to run the clinical studies properly. Finding the right CRO can make a great difference in your product’s chances of receiving registration approval and the timeline to get your product to market. If you are looking into conducting clinical trials in Asia, avoid potential serious problems by considering these important points.