There is an unprecedented level of support among regulators to advance the adoption of decentralized clinical trials, yet companies that undertake this mode of research need to be mindful of some of the challenges that can derail these efforts.
Sponsors should keep their computer systems secure, closely adhere to patient privacy laws, as well as follow good clinical practices and adopt flexible uses of technology to ensure data can be collected remotely.
So asserted two experts in the field of decentralized research who discussed their perspectives on how to make these types of trials work at a June 21 the meeting of the Drug information Association in Chicago.
“Health related data are targets … ransomware is occurring, and phishing attempts is a real and present danger that can bring organizations to their knees,” said Jonathan Andrus, president and COO of Clinical Research IO (CRIO), who along with Megan Petrylak, executive vice president of Clinical Ink, shared their viewpoints on overcoming challenges to decentralized research.
Major support for decentralized trials
Andrus said there is an unprecedented level of support for decentralized trials among regulators and industry members. “In the 26 years of doing this, I have never seen such great efforts by industry and regulators” to drive decentralized research forward, he said, noting that many regulators, including the Danish Medicines Agency (DMA), Switzerland’s Swissmedic, the European Medicines Agency (EMA), and the US Food and Drug Administration (FDA) have either published or are about to publish guidance on decentralized trials.
FDA officials said the agency is embracing new tools, including digital tools and decentralized models for conducting clinical trials as a new way of working in a post-pandemic world.
Andrus said the one theme that dominates in his conversations with regulators is that “GCPs is the fundamental concept that must be valued and is the core value that you should follow. These principles are inherent in everything you do.”
Several groups have emerged in recent years to help advance decentralized trials, one of these groups is called Decentralized Trials and Research Alliance (DTRA). The alliance has four priorities: establishing a common nomenclature and definitions for decentralized research, identifying best practices, promoting education for information sharing and removing barriers to decentralized research.
Regulators offer feedback on DCTs
Some of the regulatory viewpoints of decentralized trials were shared in a recent survey presented by Andrus. Pharmaceutical companies sought feedback on their decentralized trials; half of these trials involved studies of COVID-19 treatments, while half were non-covid treatments.
The survey collected feedback from eight regulators, including Japan’s Pharmaceutical and Medical Device Agency (PMDA), FDA, Germany’s Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich Institute (PEI), the DMA, Swissmedic, Taiwan’s Food and Drug Administration (TFDA), Belgium’s Federal Agency for Medicines and Health Product (FAMHP) and Colombia’s National Food and Drug Surveillance Institute (INVIMA).
Industry sought responses on a range of elements of trial decentralization, including the use of eConsent, at home drug shipments, electronic clinical outcome assessments (eCOAs) and patient engagement, televisits, and mobile research nurse visits.
The overall feedback: regulators found no roadblocks or concerns with remote studies. Other notable feedback: companies should seek local ethic committee approval for trials; while others urged companies to verify and ensure clear delineations between the site and home nursing providers and how they would work together.
Andrus noted that some national health authorities have stricter interpretation of GCP than others that requires site-level ownership and access to patient data or requires the principal investigators to access any data collected outside the site as part of the hybrid or decentralized trial data collection.
Cybersecurity
To ensure the success of these trials, organizations should ensure the security of their computer systems, said Andrus. While credit card information sells for around $1 per person on the black market, healthcare records can sell for $75 per person. He said that non-financial institutions are identified as an “easy target.”
He added that ransomware especially targets electronic clinical vendors. “What enables this is unsecured facilities, systems, data documents and email … or the underlying application code is susceptible to attacks.”
Use technology as an enabler
Petrylak also advised companies to explore alternative uses of technology to facilitate remote data collection. She explained how this could work in two case studies: the first involved a very large Phase 3 clinical study to treat early onset Alzheimer’s disease and enrolled 6,000 patients over the age of 55. Patients used provisioned devices to draw images such as a clocks and 3D boxes from home, and assessments were all done remotely using call detail records (CDRs), Montreal Cognitive Assessments (MoCA), category fluency, as well as other types of cognitive assessments.
The second case study involved a Phase 2 COVID-19 trial that enrolled more than 1,000 patients at 80 sites. The participants were over the age of 60 and resided in long-term care facilities. Off-site visits and tele-visits were not feasible. The sponsor relied on the use of electronic tablets to capture data remotely. Petrylak said, “The traveling nurses or the coordinator brought the tablets to the patients … all of the work was done on a tablet.” The electronic tablet was especially useful because wireless internet access was limited at certain sites.
“This solution allowed for completely off-site capabilities, so the traveling nurse worked completely offline while they were in the care facility. Once the coordinator nurse was on WiFi at home, all the data would be downloaded for access through remote capturing of data.”
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