Cost of Disrupted Clinical Research Due to COVID-19 Equates to $10+ Billion & Potential Study Delays

Researchers Seek Innovation to Save Threatened Studies

By: Brandon Woolsey, CTO & Co-founder of HiDO Health

What if you developed a potential cure for COVID-19, but couldn’t test the drug because of COVID-19? Thousands of researchers worldwide are facing this dilemma, as clinical studies are interrupted, altered, postponed – or even cancelled – due to pandemic restrictions. And industry experts project the resulting negative impact on new therapy development, patient care, drug adherence, and explosive costs will affect healthcare for years to come.

As stated by the National Institutes of Health (NIH) Director Dr. Francis Collins in his testimony to the Senate Health, Education, Labor and Pensions (HELP) Committee, the cost of lost NIH-funded research due to COVID-19 restrictions is estimated at more than $10 billion. Standard industry estimates 85% of all clinical trials will experience delays; 94% delayed by over a month at a potential financial impact of $600,000 or $8 million every day.

Of greater Industry concern is lost time due to the pandemic. According to life sciences analytics firm GlobalData, nearly 200 companies have stopped or delayed trials because of the pandemic, due primarily to suspended enrollment. Reports Brooke Wilson, associate director, GlobalData Trials Intelligence, this data is a key indicator that COVID-19 will dramatically impact future regulatory approvals.

While standard, pre-pandemic pharmaceutical and medical device studies typically required: detailed study design; comprehensive protocols requiring multiple points of patient interaction and testing; ongoing researchers/physician contact for patient recruitment and retention; travel; conferences; presentations; peer-review, etc., before the therapy is approved for market use, organizations such as the Centers for Disease Control (CDC), National Institutes of Health (NIH), and the Food and Drug Administration (FDA), report receiving multiple queries/concerns regarding clinical studies negatively impacted by COVID-19 challenges.

States the NIH Office External Research (OER), “We are aware that many institutions have ramped down their on-campus research activities to help slow virus transmission. They have developed plans for how staff will maintain the viability of critical laboratory functions. Some institutions are taking a tiered approach to their conduct of clinical trials and other research involving human participants. Outside of COVID-19 work, researchers have suspended enrollment in some, if not most, clinical trials, while modifying protocols for previously enrolled participants to minimize person-to-person contact. We also know that many researchers and their staff are working from home, analyzing data, writing manuscripts and applications, planning future research projects, and meeting virtually with collaborators.”

These organizations are rapidly responding to accommodate or clarify. As recently as June 3, 2020, the FDA updated its “Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency Guidance for Industry, Investigators, and Institutional Review Boards.” The CDC is allowing for appropriate grant submission extensions. The NIH Deputy Director for Extramural Research Dr. Mike Lauer’s office posted video recommendations outlining NIH flexibilities due to the public health emergency.

“The last four months have had clinical researchers focused entirely on study continuity – how to make sure patients could still access study medications they may be dependent upon, how to monitor and ensure safety for those research participants, and how to continue to capture critical data to understand efficacy and safety, states Craig Lipset, adjunct assistant professor at Rutgers Biomedical and Health Sciences Department of Health Informatics, founder of Clinical Innovation Partners, and former head of Clinical Innovation of Pfizer’s Global Product Development. “All enrollment of new patients in studies outside of COVID-19 ground to a halt, and all new studies were paused. The world’s pipeline of new medicines has seen an unprecedented pause that will trickle forward into delays for all new medicines reaching patients over the next 3-5 years.”

To address these issues and avoid further disruptions, the NIH and other regulatory bodies are allowing the modification of protocols to virtual studies, home delivery of study medications, compliance monitoring, and limited or suspending travel. But this flexibility does not address all research issues (some present pre-pandemic).

The difficulties of trial participant recruitment and retention have been exacerbated by COVID-19. Researchers cite patients’ elevated unwillingness to enroll in new trials, patient dropout, and noncompliance due to travel restrictions and quarantined areas. According to a study conducted by Continuum Clinical, 39% of US sites surveyed said they believe patients will be much less, or somewhat less, likely to enroll in new clinical research trials. Other considerations include increased patient anxiety and hesitancy to visit healthcare facilities, and the contamination risk between patients, sites, and the community.

Inconsistent medication adherence remains challenging. Doctors estimate about half of all medications for chronic conditions are not taken as prescribed, resulting in more than 100,000 deaths annually. The financial impact of this non-adherence is not trivial. According to a Capgemini and HealthPrize Technologies report, medication non-adherence costs the pharmaceutical industry $637 billion in lost revenue annually worldwide; $250 billion in the US alone.

However, while causing potential obstacles, concerns, costs, and delays, industry analysts also acknowledge an unprecedented exploration and adoption of clinical research innovations and technology as a result of the pandemic.

“A focus on trial continuity has opened the doors for researchers to leverage new approaches and technologies that already existed, but struggled for adoption,” states Lipset. “Tools to remotely monitor patients, enable video visits, shift location to the participant’s home (with visiting nurses and drug shipments to home), monitor study data more efficiently – all of these existed prior to COVID-19. But no companies fully embraced the new approaches – until the pandemic.”

Alexander T. Limkakeng Jr., MD, MHSc, associate professor of Emergency Medicine and the vice chief of Research for the Duke University Division of Emergency Medicine; and Judd E Hollander MD, associate dean for Strategic Health Initiatives at Sidney Kimm, recently published examples of pandemic-fueled innovation engaged accelerated clinical research, including “teleresearch,” artificial intelligence, and wearable activity monitors.

Companies such as Northern California-based HiDO Health incorporated all of the aforementioned into a low-risk medical device sent to, and operating directly from, a clinical trial patient’s home. Upon the trial participant’s recruitment into a study, the patient receives a HiDO device that is roughly the size of a coffee machine. Study drugs are pre-filled to trial design specifications and into standard pharmacy bottles featuring smart HiDO caps. The HiDO platform knows the name of medication, quantity, frequency of dispensing, and dosage, thus eliminating user and medication errors. Each time the device dispenses the medication, a short video captures the medication consumption while recording “real-time” patient compliance data that is leveraged by trial researchers. HiDO also allows researchers to incorporate app or call reminders if the medication routine is forgotten or interrupted, increasing patient engagement and reducing study adherence-related delays. And patients can follow their trial progress and communicate with researchers at any time throughout the process. Researchers, pharmaceutical companies, and regulatory agencies can quickly and remotely monitor medication adherence, effectiveness data, and improve patient care while maintaining social distancing required for patient safety.

Recognizing both the significant COVID-19-related clinical research challenges and the resulting willingness of all parties (clinicians, regulatory bodies, patients, etc.) to incorporate study design innovations and new technologies to continue clinical research, what will be the ‘new normal’ for researchers post-pandemic?

“The ‘new normal’ will include a move, when possible, from the clinic to the home to realize not only significant cost savings benefits, but also to shorten the timeline it takes to obtain accurate data and develop statistically significant conclusions,” projects Martin Torres, director of Pharmacy: Quality, Safety, Education & Research, University of California, Irvine Medical Center. “If clinical trials can be effectively moved away from the clinic to the home with documentation of data having the same quality and confidence as the clinic environment, there is a significant cost savings benefit and efficiency that the pre-COVID model did not utilize. There really wasn’t a significant universal driver for this change in the pre-COVID model.”

Concludes Lipset, “Decisions on what will be made ‘the new normal’ must be based on what is right to accommodate patients and participation, rather than what is made to accommodate COVID-19. These same countermeasures for the virus will help improve access for more patients to participate in research, in particular underserved populations for whom accessing a research site was simply not practical. Research organizations know there is a commitment needed for things to become the ‘new normal,’ and it takes more work than simply saying so.”

Prior to co-founding HiDO Health, Brandon Woolsey held leading engineering roles at several early stage companies where he managed a team of technologists in Europe and the United States. Brandon developed the key elements of the intellectual property and helped shape overall company development, design and engineering. Brandon studied biomedical engineering at UC Davis and has a minor in literature.