Decentralized clinical trials (DCTs) have become a strategic priority for most pharmaceutical organizations. Initially viewed as a nice-to-have pilot, the approach is now the go-to trial method following the impact of the covid19 pandemic.
The social distancing requirements occasioned by the coronavirus pandemic forced more than 76% of over 200 global clinical trial sponsors to conduct most or all of their patient monitoring remotely.
According to Florence Healthcare 2021 State of the Industry Report, this is more than four times the number of remote clinical trials in 2019. The 77% CAGR from 2019 to 2020 is also significantly higher than previous growth rates.
According to ZS’s DCT database referencing data from more than 1,000 trials, interventional DCTs only grew at 7% CAGR between 2014 and 2019.
Now, it appears that decentralized clinical trials are here to stay. Below we discuss what needs to happen going forward.
Decentralized clinical trials (DCTs) are defined as studies executed through telemedicine and mobile/local healthcare providers using digital technologies that allow remote monitoring.
The most common form of decentralized clinical trial is the remote decentralized clinical trial (RDCT). RDCT is an operational strategy for technology-enhanced clinical trials that involve moving clinical trial activities to more local settings to make them more accessible to participants.
Technology is the keyword, though, whereas decentralization is a matter of perspective. Essentially, participation is diffused outside the trial site so that participants avoid the inconvenience of traveling to traditional sites.
While the site was initially a proxy for the participant, the means through which participants engaged in the clinical trial, participants can now keep in touch with the trial digitally from the comfort of their homes.
We’ve established that decentralized clinical trials (DCTs) are the approach for the future. But how can we make them better?
The biggest question surrounding decentralized clinical trials recently is viability. Sponsors and CROs have for a long time wondered whether DCTs can work. Is the technology available? Will the patients accept it? What about the logistics? These are just some of the questions we’ve heard in the past.
Many of these questions have recently been answered to a conclusion as the coronavirus pandemic forced the industry to adopt digital and virtual solutions to prevent disruption in the sector.
For instance, to meet patient’s social distancing and safety needs, the industry adopted online enrollment tools and electronic consent solutions. These solutions allow patients to participate in trials remotely.
The only challenge remaining is creating a common guideline for decentralized trials. None exists currently, with the details of trials largely dependent on the type of therapy. For instance, a dermatological trial can incorporate virtual engagement more easily than cancer trials.
Organizations must try to find common solutions that can support a wide range of clinical trials rather than leaving the details to the involved organizations.
A flexible technology platform that offers a spectrum of tools and capabilities, including electronic consent, supply chain management, self-reporting of data, and a centralized investigator site would go a long way to streamlining the industry.
Clinical trials are never easy. Aside from the technical aspects of conducting a fault-free trial, they place a massive burden on participants.
Reporting and monitoring are particularly major issues. Sometimes the trial may ask patients to report in person while the patient feels it would be safer to do so virtually.
Alternatively, a patient may want a specific location while the trial team insists on a different location.
This is the next thing clinical trials must address. The industry must understand that patients have different needs. Interviews show that sometimes individuals under a remote trial program don’t want anyone to visit their home.
Pharma and CROs must find ways to meet these needs. Only when we accommodate individual needs can we increase patient enrollment and boost patient engagement throughout the trial.
There are different approaches to solving this problem. According to a 2019 study by the Center for Information and Study on Clinical Research Participation (CISCRP), organizations can consider participatory surveys (29%), text messaging (21%), and electronic informed consent (15%).
Other solutions that can boost participation include the use of smartphone apps and wearable devices for greater convenience.
Convenience-boosting solutions positively impact improve the overall participant experience. For instance, trials that offer childhood exceed patient expectations 40% of the time.
Although decentralized clinical trials are currently the wave, they come with many challenges that may make them impractical in some scenarios.
Alternatively, research facilities may have to redesign research approaches to create decentralized test protocols that work.
One way out of this problem is bringing patients and partners together in a co-creation session around a particular trial and using the insights to draft a protocol that works for that particular trial.
For instance, you may decentralize only certain aspects of the trial, such as site visits, and establish goals around the new guidelines.
Research organizations are also encouraged to create governance committees or internal consultancy systems bringing together cross-functional leaders.
Such leadership groups can provide expertise as well as help assess successes and challenges throughout the study.
In the end, it’s about finding a patient-first approach that caters to the specific needs of the participants to ensure that the study captures the patient population it seeks without location-occasioned limitations.
The best approach also involves partnering with patients to determine the tools and processes most desirable to the participants.
Implementing a flexible, hybrid approach that supports a wide variety of studies while taking into account patient needs will be key to successful trials moving forward.
Decentralized clinical trials are finally a reality. Once a far-fetched dream, the industry has now developed the capacity and tools to conduct viable DCTs with accurate results and within industry guidelines.
However, this doesn’t mean everything is fine now. While decentralized trials offer an unprecedented level of convenience and herald a new era in clinical trials, a few challenges persist that may require a collective effort.
The issue of patient choice and finding common guidelines, for instance, make DCTs a little challenging. Stakeholders must come together to find common solutions to these problems.