COVID-19 revealed how vulnerable our medical systems really are and highlighted the risk of having patients congregate at medical centers. This has led to the decentralized trial, in which patients get better care through virtual consultations without ever having to go to a clinic. Because of the pressures of the pandemic, many countries have already adopted techniques and methods to help them run decentralized trials. These are very different from the way trials have been done in the past.
This article will look at how decentralized trials are quickly becoming the new normal, thanks to the pandemic acting as a catalyst.
Why Decentralized Trials?
A centralized clinical trial has a single location and administration where studies are conducted. A decentralized clinical trial uses digital technology to carry out a huge range of studies across potentially limitless locations.
The pandemic saw the rise of decentralized testing sites as a matter of necessity. In this kind of trial, patients are encouraged to participate from various locations with the help of digital apps. They are screened online and get alerts on their app that tell them where the closest trial site is where they can get clinical care in person.
Since a decentralized trial reduces the amount of time and cost it takes to participate in a trial, it ends up increasing participation and has high retention rates compared to regular trials.
This method of study can manage a higher volume of patient data than regular trials,but requires aires strong technological infrastructure to keep things up and running.
Decentralized trials solve two of the biggest problems with clinical trials:
- Retention
- Convenience
The decentralized trial method combines site-based and home-based activities to conduct the trial, making it extremely convenient for those suffering from illness, who find it difficult to travel, and for those who find it too inconvenient to stay at the site for the entire duration of the trial.
The decentralized trial method existed before the pandemic but was not commonly used across studies until the pandemic accelerated the virtualization and digitization of the clinical process.
And since the pandemic shows no signs of ending, a growing consensus is emerging that it might become a permanent fixture in the field of health care.
Advantages Of Decentralized Clinical Trials
The biggest advantage of decentralized trials is their patient-focused nature. Regular trials end up selecting from a very biased and narrow pool of participants who live in a specific geographic location because they happen to be close to the testing site.
Because of its convenience and ease of participation, a decentralized clinical trial ends up being much more inclusive of different individuals who might come from marginalized communities. This gives better data because the study doesn’t focus on a small group of people. This is a big problem that regular clinical trials face right now.
The more age groups, genders, ethnic groups, and income groups that participate in the clinical trial, the more valuable the study is going to be.
Since the trials themselves are going to yield good data, this increases the chances of sponsorship as sponsors are convinced of the diversity in their data points.
Aside from the pandemic, the best thing for decentralized clinical trials has been wearable technology. These little gadgets allow individuals to measure their biomarkers at all times without needing complex medical gear.
Clinicians have also gotten used to how long it takes to learn how to use the equipment used in decentralized trials. This means that future results could be even better.
Because of all these benefits, it’s expected that the number of people taking part in clinical trials will go up by a lot. Researchers should get ready for this in the near future.
Anticipated Challenges
Ironically, one of the largest challenges facing decentralized clinical trials is that the data collected is too much. Staff will have to spend days, if not weeks, pouring over materials, finding data points, and noting the crucial points of interest.
This could make decentralized clinical trials far more time-consuming and expensive than traditional ones.
This, in turn, forces studies to optimize their data collection, organization, and evaluation processes. Integrations that can transfer data points between different platforms will play a huge role here. Many electronic data collection tools are not cross-platform friendly, requiring the clinical research team to transfer data in worst-case scenarios manually.
There is a large gap in the market for clinical trial software to integrate with multiple vendors and multiple platforms to protect the fidelity and integrity of the data collected through this process.
The strengths of decentralized clinical trials also become their biggest weaknesses.
The flexibility afforded to participants means they can take part while they’re at work, shopping, or waking up at night to take care of their newborns. These are normal aspects of everyday life, and knowing how a drug or device interacts with these events is important. But since the participant is free to change their environment at will, unlike when participating in laboratory conditions, the data is vulnerable to getting skewed.
Researchers could see jumps in blood pressure because of the average working conditions of the individual in stressful jobs, or the average climate changes can affect the temperature of the participant, wildly interfering with the drug’s mechanism of action.
Unlike in a lab, participants may live in a chaotic environment, which makes it hard to come to safe, reasonable conclusions about the study as a whole.
Conclusion
Decentralized trials come with a huge host of benefits that could propel the field of healthcare forward with a velocity never seen before.
The strengths of this methodology rival its challenges. Clinical research teams have to design flexible and meaningful protocols to ensure they can handle all the data they receive. Thankfully, the COVID-19 pandemic has already shown that our research professionals are more than capable of rising to the task.
With the help of digital technology and creative thinking, these problems can be solved and effective trials can be made that could be a huge help to humanity in the future.
