Decentralized clinical trials are the future of clinical research. They combine the power of online patient recruitment and centralized data collection with the ability to deliver healthcare at scale. According to ObvioHealth, (https://www.obviohealth.com/resources/decentralized-clinical-trials-a-comprehensive-synopsis) decentralized clinical trials challenges do exist, however.
The promise is that they will improve patient access to clinical trials with lower cost and time to study completion – two cornerstones of the legacy system.
However, these trials are not without their challenges. Here are some of the potential benefits and pitfalls to consider.
The Benefits of Decentralized Clinical Trials
Access to Local Patients
Centralized clinical trials have patient databases maintained centrally. This means they can’t access some of the best sources for participant recruitment – local populations.
Even when centralized data is available, it’s often incomplete and difficult to follow up with subjects without incurring additional costs.
Decentralized clinical trials offer a solution to this problem by tapping into social media and other sources for recruitment. Even more, they allow direct access to their participants.
Easier Subject Screening and Enrollment
Clinical trials are often difficult to get enrolled or screened, especially when unique expertise is required.
Decentralized clinical trials enable local doctors and patients to screen and enroll eligible subjects. This significantly reduces the number of participants required for a given study.
Wider Contribution to Medical Knowledge
Centralized clinical trials typically test one or two drugs or therapies at a time. They claim to help generate specific data about safety and efficacy against a single disease process.
However, the reality of modern medicine is much complicated. Many diseases are caused by multiple conditions, genetic predispositions, and lifestyle factors.
On the other hand, decentralized clinical trials can study a wider number of treatments. They generate knowledge about how these interventions work in combination with other therapies over longer periods. With this information, doctors can determine the most effective treatments for individual patients.
Enhanced Data Sharing and Collaboration
Decentralized clinical trials are often more collaborative by nature. As such, they focus on recruiting physicians who are already treating large numbers of patients with a given condition.
The combined enrollment across multiple studies enables researchers to conduct more comprehensive statistical analyses of their data. This, in turn, increases its value to the medical community.
Additionally, the team behind decentralized clinical trials is often more willing and able to share their findings with other researchers. It can speed up discoveries across a range of different diseases.
The Common Pitfalls when Conducting Clinical Trials
Regulatory Requirements
Even though decentralized clinical trials are inexpensive to run, they still need to follow the same federal regulations as their more expensive counterparts.
This means that all participants must be properly screened for safety. All the consent forms must be reviewed and approved by an institutional review board (IRB), and medical records must be maintained per good clinical practice guidelines.
Difficulty Reaching Large Populations of Patients
One potential downside to decentralized clinical trials is that they are challenging to execute on a sufficiently large scale, especially concerning rare diseases.
It simply takes time and resources for local physicians to screen their patient populations for eligibility, follow-up with interested participants, and document their results.
In the end, this means that getting a truly random or representative sample of data is much difficult with decentralized clinical trials.
Not As Many Quality Research Studies
Compared to central clinical trials, decentralized clinical trials might produce fewer high-quality research studies. This is due to the smaller number of participants involved over a longer time.
Limited Statistical Power
Decentralized clinical trials are more likely to produce results that cannot be generalized across the public. This often happens when it comes to rare diseases and conditions like stem cell transplants.
It is because these trials often rely on a relatively small sample size compared to their total patient population and recruitment period.
However, findings from decentralized clinical trials can still be extremely valuable for future research studies.
Data Integrity Issues
The lack of oversight and regulation for decentralized clinical trials can also increase the potential for data integrity issues. This is why it’s crucial to vet both study leaders and participants carefully.
For instance, decentralized clinical trials need to ensure that all participants receive the proper treatment and follow-up care during their enrollment period.
They also need to keep track of any special requirements, such as maintaining a pregnancy registry for patients undergoing fertility treatments.
Decentralized Clinical Trials Challenges Summary
Decentralized clinical trials are a promising and affordable option for researchers looking to maximize the potential of their resources. However, both patients and physicians need to be on the same page to understand how these trials work and what they can and cannot do. They are life-changing in the medical field.
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