Five considerations for the future of decentralized clinical trials

By John Mann, vice president, Life Sciences Operations for Americas, Vault Health
(previously VP at ICON when authored)

Despite the nearly two-year scar of COVID-19, according to Becker’s and the FDA, some changes driven by the pandemic will stick and Decentralized Clinical Trials (DCT) appear to be among them. Health systems immediately get the downside of fewer patient visits with DCT, but there is an upside to a potentially larger geographic radius, a bigger patient pool, and happier patients. Here are a few considerations to think through with DCT.

1. Getting Ahead of the Trend.

Though ill patients often appreciate not traveling to the research site for every appointment, it can also benefit health systems that get ahead of the trend. With Covid-19, many were pushed from being avid watchers to active players. There are now many companies gearing up to take on research procedures remotely and research-eligible patients, so getting a head start on a coming trend can’t be bad.
Several study findings have also validated these trends. For example, remote blood pressure screening and glucose levels test are the most popular form of decentralization. However, other insights sometimes depend on the disease or trial phase. Overall, DCT growth has been stronger in Phase III trials than in Phase II. In oncology, reports show less than 1% of trials mention telemedicine, but other indications often utilize more digital data collection. Though oncology may be hard to keep track of, it does not mean there is lack of involvement among players because trends in DCT enable more patients—often with more severe illness—to participate in trials they may not have participated in at a typical clinical trial site.

Now regulatory agencies that have been notoriously slow to adapt are changing, too. The FDA, for example, is allowing direct connectivity to patients at remote sites. Blood draws, pulmonary function tests, even infusions, all can be done at the patient’s home with home healthcare.

2. Think Hybrid First.

While some research sites worry sponsors or CROs will go straight to patients, the good news is sites remain involved in hybrid models where participants visit the site and do some at-home care. The level of DCT and number of visits depend on the study and of the participants themselves.

Though some studies can’t or don’t qualify as DCT yet, for many indications it is a real possibility. The question is not one of complexity, but it’s about doing something on-site that could be done at home. Not every trial can be force fit. If re-writing existing protocols adds weeks or months to the study timeline, it doesn’t make sense. But it might in the future–perhaps involving some form of tele-medicine for example. Safety and quality of care are the determining factors. If we don’t know the potential risks and it’s early-phase, it may be too high of a risk, but sponsors are beginning to think through those things with more frequency. In a year or so, we’ll see more sponsors writing different protocols.

Following the definition of DCT created by the FDA, most say 95% of DCTs are a hybrid of some sort. Often the patient comes in for an initial visit on week one, then visits 2 through 5 are remote. Visit 6 is at the site, maybe because it requires imaging or other test, but visits 7 to 11 are at home with visit 12 within the site again, and so forth. It’s practical to consider that patients do not have to take time from work to participate in this type of hybrid study.

3. Does the Study have Patient-centric Protocols?

The benefits to patient-centric protocol development are evolving, too, for study sponsors. While patients are less willing to venture into hospitals, protocol changes have dramatically increased ratings in patient satisfaction surveys, for example. Research retention is higher—some say it may be as high as 85% or 90%, instead of 60% or 70% traditionally.

What makes a protocol or procedure different can be who performs the responsibility, or eliminating or changing a protocol to make recruitment and retention easier. In one case, a concierge at a medical call center reminded patients of a wearable. It was not the research coordinator’s responsibility to make sure each patient was device adherent. The protocol had changed based on the responsibility and the caller.

Patient-centricity is also a real consideration as it relates to patient diversity. There have already been multiple papers and studies showing that diversity dramatically increases, including racial, ethnic, and gender. It’s not completely shifted, but significant changes have been reported with DCT.

4. Digital Technology and DCT are not the Same.

The use of technology doesn’t necessarily make a trial decentralized. Using ePROs, eDiaries, or eCOA devices where a patient has always had to fill out a diary or report, but now it’s in electronic form, for example, doesn’t make a trial decentralized. If all visits occur on-site, and nothing changes procedures, even if done with an electronic, that’s not decentralized.

Still, digital devices are less of a challenge than originally thought. We’re seeing 95% compliance regardless of age. The prevalence of mobile phones and some level of electronic savvy continues up into people’s 70s and into the 80s.

5. Real Technology Issues to Ponder

Even with the patient visit concerns and responsibility shifts, community hospitals appear to be quite interested in DCTs. However, the biggest consideration is technology.

While IT could require an upfront investment for a health system, belonging to a consortium like GRN can make technology, security, and privacy concerns doable. Regardless, DCT requires a data infrastructure that can be curated for use in consuming data, meaning computing, reviewing, or reporting data, generally the same infrastructure required for any research.

With DCTs, however, there may be more data types, more sources, and more volume–both structured and unstructured. Regardless of traditional or DCT methods, study technologies must have consistency and harmony across data. Ensuring trial data can be easily accessed, matched and available to research coordinators is critical for the clinical compliance and the safety of patients, whether onsite or at home. Yet with the right technology, study sponsors and healthcare organizations can run flexible, successful trials with more patients.

Moving Forward

Despite some challenges, decentralized clinical trials have exploded in popularity, particularly hybrid trials that combine remote healthcare, technology, and in-person site visits. It seems the patient-centric focus is just the right thing to do. Not only does the added flexibility encourage patients to participate in clinical trials, collecting patient data more frequently and from a variety of points, can even give clinical trial staff a more accurate picture of patients’ reactions.

Finally, regulatory agencies are now seeing that DCT has worked just fine as well. They’ve got it, and they are issuing and encouraging regulatory directives that allow intuitive technology and innovative concepts to overcome challenges to building effective decentralized trials. Many researchers acknowledge that business is moving to patients’ homes, which could require other strategic decisions. But, if research retention is higher and recruitment is easier, they agree that more patients can potentially benefit from DCT research.