The use of decentralized clinical trials (DCTs) has increased significantly over the past year. Researchers were forced into this option because of hospital limits and local lockdowns created by the COVID-19 pandemic. However, as vaccine rates have increased, the use of decentralized trials have remained high. This trial method is the future. Here’s how researchers are taking advantage of this trial design option and what the future holds for decentralized trials.
To understand why decentralized research has become so prevalent, it helps to look at the scale with which the COVID-19 pandemic affected global clinical trial activity. John Z. Xue et. al, of McKinsey & Company, note the spike in suspended trials due to the global health crisis. By May 2020, 1,162 trials were paused, affecting everything from oncology to cardiovascular treatments.
Even as these trials started to resume, they faced competition for resources against COVID-19-related trials, of which hundreds were launched in the spring and summer of last year. Trial developers needed to become more nimble. They needed to work around lockdown guidelines and make their research efforts more streamlined and affordable without sacrificing quality. This is where decentralization came in.
After more than one year of DCTs, many researchers want to continue with the method. They have had time to hone their practices and better understand the benefits and drawbacks of this design choice.
One of the main benefits of decentralization is the ease of patient reporting, which positively impacts clinical trial retention. Researchers are collecting larger data sets because patients can record daily updates on their smartphones or home computers.
“In our asthma and allergy study with 2,000 people, we had one person drop out after a year,” says Dr. Nirav Shah, chief medical officer at digital health company Sharecare. “We had 10% of patients enrolled in the clinical trial fill out allergy symptoms every single day for a year.”
This was made possible by opting for a decentralized model where patients could log information via smartphone instead of calling a medical professional or driving to a clinic.
Not every decentralized trial means patients report from home. These trials also refer to studies where patients visit local healthcare offices instead of traveling cross-country for tests at a university or pharmaceutical organization.
“Decentralisation doesn’t mean conducting trials in the absence of healthcare professionals,” says Christopher Kennedy, CEO at Elixell Therapeutics. “Nor does it mean (in most cases) completely eliminating the need for any physical patient contact. Instead, it’s about looking at areas where technology and other novel solutions can enable sponsors and CROs to take a hybrid approach to clinical trial design.”
DCTs can balance clinical intake data with real-world data, or information collected outside of a hospital or doctor’s office. This data can strengthen a researcher’s reports on the success of the study.
“Real-world data can be complementary and contextualize randomized-controlled trials,” says Donna Rivera, associate director of pharmacoepidemiology at the FDA. “COVID-19 has disrupted health care and forced flexibility and considerations of alternative strategies for trial conduct.”
This is another instance where the right technology is key. These technology systems need to talk with each other. They need to align similar data sets collected in different ways while ensuring that all data sets are easy to read.
“In order to support the widest range of clinical trials, organizations should look to flexible technology platforms that offer a spectrum of tools and capabilities such as electronic consent, self-reporting of data, centralized investigator site, supply chain management, and others,” says Jennifer Turcotte, head of global strategy for the pharma/med device industry at Salesforce.
Looking ahead, more contract research organizations (CROs) and trial developers are working to understand what technology they need and what they should invest in. Specifically, as sponsors are set budgets for new clinical trials, having trusted data is more important than ever to getting optimal trial results.
There are also wide-reaching socioeconomic benefits of investing in DCTs in the future. Ease of access means more people will be willing to participate, which can help with recruiting people of different backgrounds.
“Diversity is a critically important factor in ensuring that new medications are being evaluated in the populations who will ultimately be using them,” says Sanjay Vyas, executive vice president at clinical research organization Parexel. “For example, testing a diabetes drug in Caucasian men may not reveal its real-world efficacy in Asian women, while testing a drug in younger people may not reflect its safety and efficacy in older adults.”
The key to increasing diversity and working with less privileged communities is understanding the abilities and needs of patients. Rather than expecting trial participants to meet the needs of the CRO, researchers can build trials around their patients.
While there are significant benefits to using DCTs in a post-vaccine world, this option has its limits. DCTs are relatively new and organizations need to develop best practices to ensure trial quality and privacy.
“In order to work meaningfully, the pharmaceutical industry cannot work alone,” write Anna Yang et, al. at MedCityNews. “Pharma needs to begin with the end in mind, actively seeking patient and [healthcare provider] perspectives through user acceptability testing and collaborating with technology companies to mold the products, software solutions, and clinical trial platforms together.”
One of the keys to success with decentralized trials is to learn from the early days of COVID-19 trial design. This can allow researchers to locate flaws and make plans to eliminate them moving forward.
“Standardization of telebusiness guidelines can help lower the time it takes to get a product to market,” says Al O. Pacino, president at BlueCloud by HeathCarePoint. “The ability to assess proposed telehealth solutions based on industry-generated guidelines could pre-empt and decrease the bureaucratic requirements of regulators such as the U.S. Food and Drug Administration.”
Instead of waiting for guidelines to come from the FDA and other groups, CROs and pharmaceutical companies can proactively invest in safe, effective DCT practices.
The COVID-19 pandemic served as a turning point for trial developers and many researchers will continue to use DCTs to benefit patient care, improve recruitment and retention, and increase diversity in trial participation.