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By: Lea Wolfinger
Decentralized Clinical Trials (DCT) have been labeled by many as a product of the pandemic, but in reality, it has been a topic of discussion and in the development process for several years. Technological advances were steadily moving it forward when the pandemic struck, and pharmaceutical companies hit the fast-forward button. Suddenly it was not only convenient and efficient to eliminate the need for patients to travel to specific sites, but it was also a dire necessity.
While DCT is patient-centric at its best, it does not eliminate connection with healthcare professionals. Rather, it makes the best of both worlds by creating a hybrid approach. Through various apps, remote medical devices, and other technology, participants can be monitored and tested in real-time. At the same time, HCP’s can make scheduled visits to homes or facilities for the occasional face-to-face meeting, or participants can be asked to come in for a minimum number of on-site visits.
Pharmaceutical companies are finding that DCTs offer multiple benefits.
Perhaps the most significant benefit is the number, availability, and diversity of patients increases. Studies have shown that 7 out of 10 participants live more than 2 hours from the research site, and 5 out of 10 are in poor health. Additional statistics show that 30% of patients drop out, 40% of trials have difficulties with enrollment, and 85% of trials fail to retain enough patients.
“Patients aren’t just statistics or data – they’re people. Many potential trial participants will be managing health conditions while running businesses, working full-time jobs, and raising families. Where this is the case, requiring patients to attend site visits, which involve hours of travel and accumulated costs, isn’t just difficult – it can be impossible.”
Making a Game Plan
Some trials may require a significant amount of on-site testing and evaluations, but many can be decentralized. There are several key factors to consider, such as communication. Will the trial directors and HCP’s be able to connect with the participants via smartphones, tablets, etc. For example, if the participants in a trial are elderly, disabled, or have difficulties using devices, will they have someone available to help them?
Another issue is technology. Is the required technology, whether remote medical devices or wearables, readily available? Will remote data collection work well for the specific trial? Can the data be collected easily? If the process is too complicated, it may deter participants from fulfilling their responsibilities or lessen the results’ accuracy. Will it require technicians to make home visits, or can the technology be managed remotely?
How many healthcare professionals will be involved? Can home visits be covered by one HCP who ‘interviews’ the patients, collects test results, and delivers it to the main site where multiple technicians and HCPs are involved in the data analysis? Will the ‘traveling’ HCP also transport devices, medications, etc., or will a technician be needed to deliver and set up devices, and a courier required to distribute medicines and pick up unused supplies?
“We have the ability to engage with our patients, learn about their lives and priorities, and apply these insights to optimize the study design and mitigate upfront risks. For example, by employing technology to conduct pre-recruitment assessment data collection, companies can understand how people live so that protocols can be customized—bringing a patient-focused experience to clinical research.
There are a magnitude of items to consider, technologies to evaluate, and risks to be taken, but DCTs bring more advantages than difficulties, and they are here to stay.
Holland reminds us,
“Whenever it occurs, clinical research will always require the expertise and experience of qualified teams that embrace a risk-based approach. By implementing a “patient first” DCT, organizations can shatter the traditional study paradigm and finally achieve sought-after improvements in patient accessibility, the unification of data, and data availability, culminating in faster, more effective trials.
We can engage with our patients, learn about their lives and priorities, and apply these insights to optimize the study design and mitigate upfront risks. For example, by employing technology to conduct pre-recruitment assessment data collection, companies can understand how people live so that protocols can be customized—bringing a patient-focused experience to clinical research.
While the COVID-19 pandemic has been a catalyst in forcing new clinical trial execution models to go mainstream, they will be part of a mix of options in the long term. The advantages are powerful, and the results are the proof—DCTs are here to stay.”