The traditional clinical trial model has faced numerous challenges and limitations in recent years.
These trials, essential for evaluating the safety and efficacy of new medical treatments, often involve a centralised approach where participants must travel to a specific location, such as a research centre or hospital.
However, the rise of decentralised clinical trials (DCTs) has revolutionised the landscape by leveraging technological advancements and patient-centric methodologies. This article explores why decentralisation is the future of clinical trials, highlighting its potential to improve participant recruitment, enhance data collection, and ultimately accelerate the development of life-saving therapies.
1. Improved Who-When-Where Accessibility
Researchers and sponsors need help with promptly recruiting participants for a clinical trial. For instance, it isn’t uncommon for participants to meet scheduling conflicts or miss an enrollment appointment due to their busy schedules.
In addition, formal studies require frequent visits to a central location with limited parking or at a far-off location from their residences, which can be prohibitively inconvenient for some people. However, DCTs are bringing new opportunities by leveraging pioneering technologies worldwide and taking the clinical trials to the subjects’ homes.
2. Enhanced Data Collection
Clinical trials typically collect a wide range of information from participants, which include information about their health and lifestyle. For instance, clinical data is generally collected via client questionnaires, medical tests, and physical examinations.
DCTs use innovative technologies to improve data collection in numerous ways. For example, they can leverage smartphone apps to collect real-time data from participants. These platforms can allow individuals to record their health status before, during and after a clinical trial using GPS tracking features or digital surveys, without having to go through physical tests or examinations at a clinic or hospital or a clinical trial site. Sites and site personnel too don’t have to rely solely on biased reporting of subjects - much of the data comes directly from the subjects instantly, without the need for further transcribing to a database.
3. Greater Flexibility For Participants
Traditional clinical studies require participants to travel to a centralised location to complete their required exams, submit biopsy samples, or receive treatment.
Some of these studies may also involve multiple visits to the same location or research centre, which
can be inconvenient for some people. However, DCTs allow sponsors to recruit participants from home. This removes the need for a participant to travel and make repeated visits to a centralised location to participate in a study fully. This is achieved by ensuring that collection of samples or even delivery of study supplies/trial medication is done directly at the participants’ location, by leveraging newer modalities and options. Sending a phlebotomist or a study nurse to the participants’ homes is now a common practice as is having shipments delivered directly to the subjects. Volunteers no longer have to come physically to the clinical trial site for such activities. This further results in better compliance, lesser drop-out rates and less stressful experiences for subjects that directly contribute to faster execution of trials.
4. Improved Accessibility For Sponsors
While the flexibility of DCTs is largely beneficial for sponsors, it also presents significant obstacles. Many clinical studies are expensive to conduct and can take years to complete. Experiences from formal clinical studies may also provide insights that lead to better theories, thus making future research more efficient and cost-effective. Trial sponsors can now have access to study data real-time and track sample collection, medication compliance and many other things almost instantaneously in DCTs, instead of waiting for final data analyses that was done typically at the end of formal studies.
Conclusion:
Decentralisation represents a paradigm shift in clinical trials, offering immense promise for the future of medical research. By embracing technology and patient-centric methodologies, DCTs can overcome many limitations of traditional practices. The ability to remotely monitor patients, collect real-time data, and enhance participant recruitment and retention can potentially transform the clinical trial landscape.
However, challenges remain, including regulatory considerations, privacy concerns, and the need for robust infrastructure. Nonetheless, as the healthcare industry continues to embrace innovation, decentralised clinical trials will undoubtedly play a pivotal role in shaping the future of clinical trials, bringing us closer to more effective treatments and improved patient outcomes.