Our team has been recently involved in a lot of medical device & diagnostic pre and post feasibility projects. We see the rise of such clinical trials as regulations changed recently. This led to a waterfall of studies coming with unclear strategies on how to be conducted, where, and how long.
Not only that but the COVID-19 outreach also increased towards the market of diagnostics and medical devices so lots of investment was directed there. So if in previous years there was a clear demand for rare disease intelligence, we can comfortably say that the new boom is in medical devices and diagnostics.
Creating a strategy in the new landscape of regulations and demand causes a lot of trouble both to sponsors and CROs.
It turned out that even the top 5 clinical research companies covering research on medical devices and diagnostics are not prepared enough to know deadlines and best institutions and timeframes for how to conduct their next studies in this space.
Here’s a list of the four main challenges they need to overcome in order to create a successful clinical trial strategy:
- Submission process
FDA, EMA, and all big institutions tend to create regulations that help unite regions with general and universal guidelines. Yet, each state or country depending on the level of flexibility has their own freedom to translate these guidelines into internal local processes.
This means that the moment you want to conduct a Phase 2 clinical trial and you need to go outside of the initial country or state you already know, you need to take into consideration the local infrastructure for approving and conducting a clinical trial.
With medical devices now, even more, because as mentioned earlier the new regulations (I am not going to go into details, but please feel free to contact me in case you need to get hold of them too), are bringing change to the status quo.
The main change is that now medical device and diagnostic studies become closer to the traditional drug trials. This means adding more steps into the submission process but also the rise of questions like:
- Do I need Informed Consent now?
- What sort of approval do I need before starting patient recruitment?
- Do I need to provide additional data during the study?
Additional steps usually mean different timelines for the submission process, contracting, and initiating the whole study. In some countries, these timelines are the same. Yet, an additional check is needed to make sure this is really the case.
In one of our latest projects, we were able to save the sponsor 30 days, just by checking their approval process and timelines.
Initially, the CRO translated the regulations as if they need to wait for a silent approval for 30 days. When our advisor jumped on board, thanks to his daily experience in the field, he was able to confirm that the silent approval for diagnostics is 10 days rather than 30 days and also you can start patient recruitment at day one unless an institution comes back to stop the process because of detected issues.
- Lack of historical data
Big CROs are in the business of manufacturing clinical trials. They do it for so many years that they run on SOPs and templates that help them streamline processes and make clinical trial conducting agile and efficient in the end.
They also rely on their datasets of data about drug trials, previous experience, and information from clinical trial registries. Yet, diagnostic studies were not required to be registered before and the majority of medical device studies are not registered too (and even if they were, their performance and timelines would have been slightly different as they operated in an indifferent regulatory landscape).
This all means that enrollment benchmarking is hard, as well as identifying institutions with experience in conducting medical device & diagnostic research.
If you are interested in how we overcome this data barrier, you can read our last success stories about:
- Sites with experience and patients:
Identifying the right institutions and investigators for conducting your medical device studies can be hard too, especially when we speak about a global study. New regulations have nothing to do here, rather the lack of registries with similar projects.
This can be also overcome as you can see in our IVD success story above, though not in the straight-forward way that the manufacturing model of trials expects. Again what is missing here is data about their previous involvement in similar trials as well as enrollment benchmarking. Site surveying can solve this puzzle in most cases by knowing who to target.
At the same time, surveys take time, something that not many companies can afford especially when doing their first estimations at the Request-for-Proposal stage.
That being said, medical device and diagnostics are not a new area of research but definitely require building more capacity in the space and won’t fit the manufacturing template of drug trials.
Access to data is important, as well as building a database of newly performed studies to learn from their performance and obstacles. If you need data to make decisions based on the clinical research market trends in the last 4 years, you can get our 2021 Market Overview. It highlights trends in therapeutic areas and geographical regions and we update it quarterly as new data becomes available.