How are decentralized clinical trials changing the face of the healthcare industry?
The concept of clinical trials brought with it the belief that hospitals, healthcare clinics, and health centers are essential for the successful execution, in-depth research, and analysis of medical experimentation. For the sake of compliance, authenticity, and safety of the participants as well as the medical staff, it was important to execute clinical trials in equipped medical facilities.
However, fast forwarding to the coronavirus pandemic, the face of the health industry, not to mention the process of clinical trials, transformed into a completely digital and decentralized mode. The pandemic threw new challenges towards the medical industry regarding diagnosis, medication delivery, treatments, and more.
Since people, especially vulnerable patients, were discouraged from getting out of their houses, even for medical counseling, the significance of digital diagnosis and remote patient monitoring was highlighted. To conclude, the necessity of medical support gave birth to the new face of the healthcare industry- Digital Health.
Along with digital therapeutics, digital healthcare, and more such concepts that are very popular due to their convenience, decentralized clinical trials are slowly taking over the previously preferred face-to-face clinical trials.
Before we delve into the importance and challenges of decentralized clinical trials, let's understand the concept in depth.
What is a Decentralized Clinical Trial (DCT)?
The idea of Decentralized Clinical Trials or “Virtual Studies” revolves around the concept of “siteless,” “home-based,” and “distributed” trials or medical investigations that do not require patients to visit the medical center of the lead researcher regularly. Simply put, it focuses on making participating in clinical trials easier for patients by reducing or eliminating commuting to the medical facility.
The primary idea of DCT is to leverage virtual tools such as telemedicine, sensory-based devices, wearables, remote patient monitoring, and home visits. Therefore, these investigations are comparatively less dependent on conventional research facilities or specialist intermediaries for data collection as compared to the traditional concept of clinical trials.
Decentralized Clinical Trials promote the idea of virtual collaborations fueled by special platforms, technologies, and tools to ease the interaction between patients, medical staff, and researchers. Besides, in a DCT, all operations, such as participant recruitment, delivery of study material, and recording of trial outcomes, are executed without any in-person contact between the research team and the participants. This approach has proven to be very successful with trial participants and has drastically lowered the dropout rates and increased the efficiency and effectiveness of the clinical trial.
While it is often believed that the concept of DCT is about doing away with physical contact with medical professionals or excludes the need for them during the trials, it is not at all true. The ideology of Decentralized Clinical Trials is to incorporate technology to bring about a hybrid approach to clinical trials (a mix of digital and face-to-face) so that it can provide a lucrative alternative to the traditional method of clinical trials, which was considered inflexible and location-centric, thus causing such high dropout rates of participants.
How have Decentralized Clinical Trials impacted the industry?
1. Convenient Trial Set-Up:
The primary goal of Decentralized Clinical Trials or Hybrid Clinical Trials (a mix of on-site and home-based research activities) is to make organizing and participating in clinical trials easy for the medical staff and patients. DCTs have enabled participants to continue living their usual while participating in the research, which has helped increase the turnout rate by significant percentages.
2. Increase in Participants:
Research has shown that over 70% of the participants in clinical trials live more than 2 hours away from the allocated research center, and 50% of the participants cannot stay till the end of the program due to poor health and fatigue. Decentralized and Hybrid Clinical Trials have greatly helped the researchers and participants increase the consistency of diverse contributors and candidates.
3. Patient Convenience:
However, one of the most prominent reasons behind the popularity of decentralized clinical trials is that over 85% of the clinical trials fail to retain the majority of their participants due to fatigue and commuting time. The loss of active participants was, in turn, hampering the much-needed diversity and the integrity and outcome of the research. Additionally, the trial procedures impacted the participants’ daily routine since they affected their schedules and monetary budgets.
Besides the above examples of significant impacts, Decentralized Clinical Trials have also helped in the advancement and modernization of clinical trials in the following aspects:
4. Educating the patients about the trials and procedures:
Due to an abundant amount of information made readily available on online clinical trial platforms, it has become more convenient for participants to learn more about the research study they are participating in. Additionally, candidates, aspiring researchers, and contributors have full access to various programs, outcomes, and research data.
5. Increase in patient onboarding:
As mentioned above, DCTs enabled research candidates to participate in the trials from the comfort of their homes without having to commute long distances. Additionally, Decentralized/Hybrid Clinical Trials opened the doors to a diverse group of candidates rather than restricting the study to be within a limited geographical area. For this reason, DCTs have hugely benefited research studies for rare diseases.
6. Accurate collection of research data:
Not only do Decentralized Clinical Trials increase the patient count, but they also provide more accurate, detailed data for the study, thus promising better outcomes from the clinical trial. This is possible because DCTs enable health workers to monitor patients remotely, around the clock, through smart devices. This provides precise data that is bias-free and cannot be tampered with at will. Additionally, since the data is being collected on electronic devices, it has fewer chances of being stolen or lost as compared to paper records.
7. Better research analysis and outcomes:
It has been observed that candidates for a Decentralized Clinical Trial are more engaged, involved, and active with the research and outcomes. The ease of participation provided to candidates from the comfort of their homes has made them more enthusiastic about participating in the clinical study. Participants of DCTs are completely tasks posted on online platforms and provide better insights to the researchers, helping them achieve better and faster results.
How to execute a successful Decentralized Clinical Trial?
Since the primary idea of a DCT is to enable the participants to be a part of clinical trials remotely, a major concern while setting up the trial would be to facilitate candidates and help them avoid site visits as much as possible.
There are several aspects that need to be considered to ensure a successful Decentralized Clinical Trial that promises fruitful results. Here are some of the points you must keep in mind while designing a DCT:
- Accessible Communication with Candidates: Determine a device for communication and data sharing between your candidates and medical team- such as tablets and smartphones.
- Ease of Commute: Keeping your research site at a far distance from the major chunk of your participants’ location, can cause a drop in the number of candidates. Try to find a popular, and easy to reach site to set up your clinical trial.
- Delivery of Medication/ necessary Clinical trial kit: Easy and efficient delivery of medication and trial kits is one of the most important aspects to consider while designing a DCT. Hiring a trained courier service, or hire a team of experts (or phlebotomists) for the transportation of medicines, collecting of samples, and performing tests is important.
- Collection of research data: For accurate and efficient collection of patient data, that is eminent to fuel the research, DCTs usually choose wearable technology like smartwatches and fitness bands to track the progress of their candidates, and store individual data.
- Keep it simple and accessible: With the development of technology reaching new heights of innovation everyday, we can choose from a plethora of devices to facilitate us and our participants for the DCT. However, choosing user-friendly, and simple devices that can fit into the participants’ daily lives seamlessly is what adds to the DCT being accessible.
- Ensure quality and reliability: Always remember that people who have enrolled in the clinical trial are trusting you with their health and deserve the best. Maintain hygiene and cleanliness of tools and thoroughly testing all procedures is necessary. Patient feedback is also a great way to improve your processes to increase your reliability and gain your candidates’ trust.
Decentralized Clinical Trials are the latest approach to clinical research and are rapidly gaining preference and popularity.
At Mahalo Health, we offer you platforms that are more than equipped to facilitate your Decentralized Clinical Trial and help your medical team monitor your patients remotely. With the latest features and customer support, we promise enhanced data collection and faster patient recruitment with no unaccounted expenses and wastage of time!
Reach out to us, to start designing your Decentralized Clinical Trial with us today.