As decentralised clinical trials become the norm, examine how to succeed with this new setup and ways to overcome the challenges that are present.
Traditionally, clinical trials are conducted in a special lab or clinic. The purpose of having a defined location to conduct these trials is to control the environment and to ensure the safety of patients, as well as the integrity of the entire study. But the pandemic is one of the biggest disruptors to modern society and it has forced every aspect of society to rethink how certain things are done – and that includes clinical trials.
Decentralised clinical trials are the new norm since the COVID 19 Pandemic. So, what are the challenges with this new setup and the ways to overcome them.
What are Decentralised Clinical Trials?
A decentralised clinical trial is one that is conducted virtually or in the patient’s home, unlike in a hospital or healthcare facility where it is traditionally done. This new setup eliminates the need for the patient to travel to the said facility where the clinical trial is to be conducted. However, this only refers to the site of the trial – the process will still be supervised by healthcare professionals.
The decentralised approach is made possible through the use of digital technologies and the collaborative effort of the medical team and lead researchers. Like a traditional clinical trial, it will be governed by a set of protocols that are defined prior to the start of the activity.
This approach is also deemed as part of the movement towards patient-centricity. Decentralising is looked at as a solution to the high drop-out rate among patients that exist in the current inflexible system employed in conducting clinical studies that require patients to be on-site. It eases the burden on the patient when it comes to the success and effectiveness of the study.
Why is There a Need for Decentralisation?
The move towards decentralising clinical trials became a necessity during the pandemic. With doctors and healthcare offices closing its doors to the public to limit the spread of the virus, clinical trials were also similarly affected. And yet, the need for investigational medicine was more important than ever. Healthcare organisations committed to find alternative ways to conduct these trials in a way that was safe for both the lead researchers and the patients who will undergo the trial.
Way back in May 2020, there was a survey that revealed only 45% of the clinical trials at that time pushed through with its activity. This statistic was significantly low given that clinical trials are the heart and soul of the healthcare industry. Clinical development studies were vital in the innovation of new medicines and an understanding of how to address specific conditions and illnesses.
Innovation has led to the concept of decentralised clinical trials. And while it is still in its infancy, many are already claiming this is the new standard for conducting clinical studies in the future.
What are the Enablers for Decentralising Clinical Trials?
Decentralisation is highly supported by the research service providers and their clients, particularly bio-pharma companies. They are looking to build on the momentum started by the pandemic in the hopes of stepping up the move towards decentralisation.
The pandemic is one of the biggest enablers to the shift towards decentralising clinical trials, but there are more contributing factors. One of them is the advancement in digital health technology. In recent years, and even before the pandemic, the uptake of health technologies has been steadily rising – both on the medical providers and patient side. Healthcare providers and clinical researchers want to exploit this in the move towards the decentralisation of clinical trials.
Patient convenience is another factor that stepped up the decentralisation of clinical trials. Patients play a critical role in the retention and success of clinical trials. Therefore, devising ways that will encourage their participation is vital in the successful implementation of the clinical studies. Healthcare experts predict that this is just one of many changes in the clinical trial setup that would take patient convenience into account.
Lastly, the maturation of digital tools that enable decentralised clinical trials to be conducted virtually or remotely is a huge contributor to enabling this new setup. Examples of these remote tools are camera, voice, and video technologies, novel sensors, and mobile eCOA, to name a few. The broad expansion of digital tools coupled with regulatory acceptance has permitted the use of alternative clinical trial approaches. The growth rate, however, of this approach to conducting clinical trials will depend on the existing regulations per country.
Challenges of Decentralised Clinical Trials
Decentralising clinical trials is not without a set of challenges or barriers. It is important to identify these challenges to develop solutions that enable ease in navigating any uncertainties involved in conducting trials, and to ensure that the results are not compromised.
The digital transformation and the pandemic contributed to the acceleration in the adoption of decentralised clinical trials. Prior to this, there is a lot of reluctance in the industry to embrace this setup, especially in a highly regulated industry.
The following are the challenges of Decentralised Clinical Trials that has slowed down the full adoption of this new method of conducting clinical studies:
- Unfamiliarity of patients in the use of decentralised elements of the clinical trial
- Preservation of data quality an issue among sponsors of clinical trials
- Finding specialised couriers and technology vendors capable of delivering supplies and equipment for the clinical study
- Efficient use of time while maintaining the quality of the clinical trial
- Patient attitude towards the conduct of the study
- Risk of technological failure and data loss
- Continuity of patient care
- Lack of regulatory guidelines and implementation of protocols
The Future of Clinical Trials: Decentralisation
Is this the future of clinical trials? According to this study, 70% of clinical trial participants live approximately 2 hours from the trial site. By decentralising a trial, it broadens the scope of the study in terms of participants and the diversity of patients involved. Geographic limitation is no longer an issue and this also reduces the workload for lead investigators and researchers.
As technologies continue to evolve and develop, one can only hope that decentralised clinical trials will benefit from the access of modern and digital tools. In fact, it may open up the doors for other models of clinical trials including hybrid set-ups, especially as some trials and studies require patient visits.
Benefits of Decentralisation
The primary purpose of decentralising clinical trials is to make clinical studies more accessible to patients. This new setup creates little to no disruption in the lives of patients, thus increasing participation rate.
Here are some of the benefits for decentralising trials:
- It accelerates the recruitment of patients as more are encouraged to participate. This is especially helpful when finding patients from rural areas or those located far from clinical sites.
- It expands patient diversity. Clinical studies can be more accurate by accessing a wider pool of patients rather than being limited geographically. It is especially helpful when dealing with clinical studies of rare diseases.
- Patients are more informed and knowledgeable of the scope of the study. Engaged patients come as a result of the autonomy of the procedure.
- Increased accuracy of data and reliability in collection because of the use of digital technologies.
How to Ensure Success for Decentralisation
Are you looking to decentralise your clinical studies? Several elements must come together to ensure the success of the study.
The first and most important element for successful decentralised clinical trials is efficient communication with patients. With access to telecommunications technology, this is easier to achieve. However, facilitators of clinical trials must also consider the method of communication, and not just the tools and technology used.
Speaking of technology, choosing the right technological tools to use for the virtual clinical study must be given plenty of thought. This will ensure that the process is efficient for the patients and to ensure the accuracy of data obtained from the study. Moreover, develop ways to ensure the security of patient data and the results of the study.
Proponents of decentralised clinical trials point out three important tenets that will ensure a successful study: accessibility, reliability, and simplicity. These factors must coexist to ensure that any of the challenges mentioned above will be overcome.