Report reveals obstacles to implementing digital trial tech
Clinical trial technology provider Curedatis has joined with software company Climedo Health to conduct a survey on technology adoption in clinical trials. According to the survey partners, results indicate the existence of challenges in various study phases and highlight the specific technologies respondents view as having the most potential.
The survey checked in with 60 professionals from medical device manufacturers, pharmaceutical firms, and consultants from across the European Union. Questions touched upon what respondents view as challenges and opportunities in planning, implementation, and wrapping up stages of their studies.
Implementation difficulties
Results of the study show implementation is the stage people view as the most difficult (rated 3.4 on a scale of 1 to 5). The next most challenging phase is planning (3.2 out of 5), then the closing (2.8 out of 5).
The challenges specific to the planning phase of studies singled out by respondents include:
- Lack of personnel (cited by 56% each, before and aftermarket approval)
- Time required (cited by 46% for pre-market approval, 62% for post-market approval)
Respondents also named challenges encountered during implementation:
- Complexity of the study protocol (cited by 69% for pre-market, 50% for post-market studies)
- Identifying appropriate patient participants (cited by 56% each before and after marketing approval).
Then, the close-out segment reportedly presented respondents with problems in:
- Data evaluation (cited by 60% before market approval, 56% post-market approval)
- Publication of results (cited by 60% before market approval, 79% post-market approval).
Digitalization potential
Respondents also spoke out on aspects of clinical research they see as having the highest potential for digitalization. During the planning phase:
- Feasibility (3.5 out of 5)
- Communication with authorities (3.2 out of 5)
- Patient recruitment (3.1 out of 5)
During implementation:
- Data capture (3.9 out of 5)
- Communication with patients (3.8 out of 5)
- Monitoring (3.7 out of 5)
In the close-out phase:
- Data management (4.2 out of 5)
- Data export (4 out of 5)
- Statistical analysis (both 4.0 out of 5)
Decentralized opportunities
Though about 80% of respondents indicated they had not yet tackled decentralized studies, more than two-thirds indicated they plan to do so sometime in the next three years. Of the participants that had conducted decentralized trials, many reported benefits:
- Cost savings (75%)
- Faster study completion (70%)
- Simplified patient recruitment (50%)
Looking ahead
When asked about what they see as the most important trends in the coming three years, respondents cited:
- Minimal on-site monitoring through eCRF integration into the electronic patient record (89%)
- Decentralized or virtual studies (58%)
- Massive use of wearables (47%)
Then, when asked about what might best help simplify the trial process:
- More willingness to use digital technologies (74%)
- Better communication with performing centers (68%)
- Clear communication of requirements from the government, such as in terms of laws and regulations (58%)
Pharma vs. med-tech
When compared to medical technology (med-tech) companies, the results show, pharmaceutical companies view the various stages of trials to present lesser challenges and see more digitalization potential in most aspects.
"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 difficulties in data analysis and publication," said Veronika Schweighart, COO and co-founder of Climedo Health. "But when asked about solutions for overcoming these hurdles, we see one recurrent theme: digital technologies.”
Schweighart added that digital technologies were cited as an opportunity by the majority of respondents in every phase, and around three-quarters confirm that the industry needs 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,” she said. “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, commented that the survey results offer useful insights into how to best organize future clinical trials.
“The evaluation shows that we need pragmatic solutions in many areas to prevent costs and personnel expenses from rising further,” Radloff said. “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 particular, Radloff said, the planning stage of a clinical trial offers great potential in achieving 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,” he stated. “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."
