New survey highlights the challenges and opportunities for clinical studies in medical device and pharmaceutical companies
Munich, Wednesday, August 25, 2021 – Together with Curedatis, the Munich-based software company Climedo Health recently launched a survey on clinical studies. The results highlight the different challenges in clinical trials and which digital technologies companies see the most potential in.
Sixty representatives of medical device manufacturers as well as pharmaceutical and consulting companies from the European Union took part in the survey. The companies were asked about their specific challenges and opportunities in the planning, implementation and close-out phases of clinical studies. A distinction was also made between studies before and after market approval.
Implementation phase the most difficult
The results show that the implementation phase appears to be the most challenging overall (this was rated 3.4 on a scale of 1 to 5), followed closely by the planning phase (3.2 out of 5) and the closing phase (2.8 out of 5).
The main challenges in the planning phase included:
- Lack of personnel (cited by 56% each before and after market approval).
- Time required (cited by 46% for pre-market approval and 62% for post-market approval)
For the implementation phase, respondents named the following challenges:
- The complexity of the study protocol (cited by 69% for pre-market and 50% for post-market studies).
- Identifying suitable subjects (cited by 56% each before and after marketing approval).
The close-out phase presented respondents with problems in:
- Data evaluation (cited by 60% before market approval and 56% after market approval).
- The publication of results (cited by 60% before market approval and 79% after market approval).
Room for Digitalization
With regard to the areas with the greatest digitalization potential, feasibility analysis was named in the planning phase (3.5 out of 5), followed by communication with authorities (3.2 out of 5) and patient recruitment (3.1 out of 5). In the implementation phase, the areas with the most potential to be digitalized were data capture (3.9 out of 5), communication with patients (3.8 out of 5), and monitoring (3.7 out of 5). In the close-out phase, respondents named data management (4.2 out of 5), data export and statistical analysis (both 4.0 out of 5).
Decentralized trials as an opportunity
Although nearly 80% of respondents had not yet conducted decentralized trials, more than two-thirds of them planned to do so in the next three years. Those who had already conducted them reported cost savings (75%), faster study completion (70%), and simplified patient recruitment (50%).
A look at the future
The most important trends in the coming three years were cited as “minimal on-site monitoring through eCRF integration into the electronic patient record” (89%), “decentralized or virtual studies” (58%), and the “massive use of wearables” (47%).
From the respondents’ perspective, we need “more willingness to use digital technologies” (74%), “better communication with performing centers” (68%), and “clear communication of requirements from the government (such as in terms of laws and regulations)” (58%) to simplify the clinical trial process for companies.
Pharma better positioned than MedTech?
Finally, the comparison between MedTech and pharmaceutical companies revealed that overall, pharmaceutical companies consider the three phases to be somewhat less challenging and see more digitalization potential in almost all areas of the individual phases compared to MedTech companies.
“The challenges in clinical studies are manifold and, depending on the phase, they range from a lack of personnel, high costs, patient recruitment and time requirements to more difficult data analysis and publication,” says Veronika Schweighart, Co-Founder and COO of Climedo Health. “But when asked about a potential solution to overcome these hurdles, we see one recurrent theme: digital technologies. These were cited as an opportunity by the majority of respondents in every phase, and around three-quarters confirm that we need more readiness for digital technologies to simplify the clinical study process. For this reason, we expect to see more and more movement in the digital data capture market in the future. This will also enable decentralized clinical trials, which are becoming increasingly important, to be conducted in a straightforward and cost-efficient manner.”
Robert Radloff, founder of Curedatis, adds: “The survey results offer us valuable insights into how we want to organize clinical studies in the future. The evaluation shows that we need pragmatic solutions in many areas to prevent costs and personnel expenses from rising further. Digitalization should not be seen as an end in itself, but above all as a precursor for downstream processes and methods, such as artificial intelligence. In our view, the planning phase in particular offers a great deal of potential for efficient study design. At this early stage, opportunities can be seized to lay the foundation for later study success, e.g. through feasibility and pilot studies. Specifically, later risks, such as slow patient recruitment or lack of motivation of patients or investigators at the study site, including study discontinuation, can be minimized or even avoided altogether. Here, the study protocol and the eCRF (electronic Case Report Form) play a key role and offer many possibilities to make studies more pragmatic and digital!”
The survey results can be downloaded here for free.
About Climedo Health
Climedo Health’s mission is to bring the best treatment to every patient by empowering healthcare professionals with intelligent software solutions. Together with Europe’s leading hospitals, we have developed a cloud-based platform for cutting-edge clinical validation and post-market surveillance of medical devices and pharmaceutical products. By digitally connecting all stakeholders (Medical Device manufacturers, Pharma companies, CROs, hospitals and patients), Climedo allows for increased performance, better cost-efficiencies – and ultimately – accelerated medical innovation.
Curedatis is a startup that digitalizes and automates the process of generating clinical evidence to help medical device, in vitro diagnostics, and digital health companies meet the requirements for sufficient clinical evidence under the MDR, IVDR, and DiGAV.
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