Since its beginning, the pandemic has affected numerous spheres of both our personal and professional lives. The healthcare and life sciences industry has taken the hardest blow, among others. Clinical trial sponsors and researchers had to think outside the box and take advantage of the technology, resources, and tools at their disposal. They had to surpass considerable challenges and provide patients with safe and effective treatments and solutions.
One of the consequences that have come out of these changes has been the transition into decentralized clinical trials. The shift hasn’t been easy, but it brought about numerous benefits to patients and researchers alike.
This article will explore the motives behind the move into decentralized trials, the changes it brought to the industry, and this trial design’s advantages and disadvantages.
Pandemic-Induced Move Into Decentralized Clinical Trials
Pandemic has created an entirely new environment where patients’ mobilities were limited and physical contact was no longer an option. The traditional approach to clinical trials was not a viable choice anymore. Enrollment timelines became longer, and protocols often had to be amended or paused. The clinical research community had to rethink the way they were managing trials and come up with a novel approach to their research.
The decentralized approach to clinical trials appeared to be the most commonly chosen response to these new conditions. Apart from its benefits, this solution prevailed over others because many CROs already had an intention to make the shift into decentralized trials shortly. The pandemic seems to have only accelerated this inevitable shift.
Move Into Decentralized Clinical Trials
The shift into decentralized clinical trials is not an easy task, especially when occurring in the midst of a pandemic. The transition, which would’ve been much smoother and taken more time, had to be completed shortly and affected differently due to the new working conditions.
The professionals involved in clinical trials implemented several steps to accelerate the shift but keep the method effective. The most common changes to their operational standards included:
Adoption of patient-facing technologies — Decentralized clinical method heavily relies upon the patients’ use of virtual tools and resources. The leverage of such tools allows them to support the research and become more involved in their treatment.
Adoption of investigation-facing technologies — The researchers’ leverage of virtual tools goes hand in hand with the patients’. Their use of technology for the processes of data collection and analysis is crucial for the outcome of the research.
Protocol design changes — Decentralized clinical trials use a patient-centric approach to data collection and research. So the shift into this new virtual trial method required a complete protocol redesign so that the objectives, methodology, and organization match the new framework.
Standard operating procedure changes — Decentralized approach to clinical trials is technology-enhanced and site-less. So, it requires a rewriting of standard operating procedures and participation strategies.
Investment in the workforce — Effective shift to decentralized trials can also entail an investment in a new workforce with knowledge and skills to help the change be as effective and efficient as possible.
Challenges of the Decentralized Approach to Clinical Trials
The researchers faced challenges in a couple of different areas due to adopting the decentralized clinical trial method. They’ve discovered that certain conditions must be fulfilled for the trial to go according to plan and give the desired results. Those conditions relate to adherence to protocol and patient engagement.
The decentralized trials’ sponsors’ primary concerns relating to protocol adherence include:
Compliance with the technological requirements and trial procedures — It’s essential that every person involved in the trial, such as investigators, study coordinators, nurses, and others, adheres to the same standard operating procedures and relies on the same technology for the trial to be successful.
Effective data tracking — Decentralized method’s use of virtual tools in clinical trials provides the researchers with an abundance of real-time patient data. Keeping track of all that data has proved extremely challenging yet indispensable for the trial to have a favourable outcome.
Usage of integrated digital platforms — Choosing virtual tools that work completely independently prolongs the process of data collection, analysis, and reporting. Decentralized trials benefit more from integrated platforms as they don’t require multiple log-ins, make the process of data transfer easier and faster, and reduce the risk of data loss.
The adoption of decentralized trials brings about the following challenges relating to patients engagement include:
Patient monitoring and engagement — Virtual approach to clinical trials heavily relies on patients’ engagement in the research process. Patients should know their role in the trial, have easy-to-use and accessible tools, and know instructions on how to properly use them to ensure the best results.
Data reliability and quality — Decentralized trials collect data in various ways depending on their requirements. So, it’s important that all the data is comparable and that the usage of different methods and tools in its collection doesn’t negatively influence the trial’s end result.
Data collection — Decentralized model’s leverage of remote data collection may affect the data standardization, harmonization, protection, and volume. So, it’s necessary that the professionals involved in the trial take all these concerns into account when deciding on the methods, tools, and procedures they’re choosing to implement.
Lack of regulatory guidance
Starting a clinical trial without deciding on the concrete regulatory guidelines may affect data quality and integrity, compromise patients’ safety, and delay the trial itself. So, you should consult about and decide on clear regulatory guidelines in the early planning stages of the trial.
Implementing Remote Data Collection Into Decentralized Clinical Trials
Remote data collection is one of the pillars of the decentralized model of clinical trials. It’s achieved through the use of remote monitoring technology. While the virtual tools used in decentralized clinical trials differ, some of the most commonly used ones include patient apps, ePRO, wearables, monitors, and mHealth and IoT devices.
Many CROs have started using these tools in the first stage of their transition into or even before making the jump into decentralized clinical trials.
According to surveys, remote monitoring technology has been extremely beneficial for patients and staff involved in clinical trials. They’re convenient to use, provide comprehensive real-time data and insight, and save time and resources for the staff
and the sponsors.
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