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The #medtech industry is experiencing the effects of Covid-19 on their clinical research goals. A news article revealed that the Food and Drug Administration (FDA) is keeping it biologics’ labs closed longer than other government facilities. FDA officials informed employees in July that they would keep the facility closed until data showing less than 10 coronavirus cases per 100,000 people in the counties neighboring the agency’s White Oak, Md., site.
The data are based on metrics from the Harvard Global Health Institute, which is classified as the community’s “Covid risk level” based on how many cases of Covid-19 are confirmed per 100,000 people. Any occurrence above 9 out of 100,000 is measured “accelerated spread”.
Since March 1, 440 studies have been postponed due to the epidemic. Of those studies, 25% was research for cancer treatment. Over 200,000 people were a part of the clinical trials, but the number of functioning participants at the time trials ceased is unknown. Compared to the prior two years, the average rate of stalled trials doubled in the first quarter of 2020. The median rate of termination was 638 trials from January 2017 to December 2019, increasing to 1147 trials between January 2020 and May 2020. Naturally, clinical research leads clinical practice by a few years, so the interruptions happening now will have possibly ongoing consequences in the future.
That is the opposite of what other government agencies are doing in the Washington area. The National Institutes of Health (NIH) allowed many of its employees back into their laboratories in June and July.
While multiple issues are delaying the access of patients to acquire treatment in clinical trials, the COVID-19 pandemic has involuntary caused over hundreds of clinical trials to stop. Drug manufacturers, health institutions, and research centers, to name a few, have all postponed numerous research projects because of the epidemic. In addition to the pandemic, logical issues regarding, funding, and the research trials are possibly at risk too. At the beginning of the pandemic funding began rapidly vanishing, leaving both occupations and statistics at risk. Trials that had interruptions but are ongoing maybe facing a decrease in existing and new enrollment, abandoned follow-up visits, and procedural changes that would could present issues during usual times and influence the superiority of the clinical trial. These issues may have an impact on compliance, data integrity, statistical interpretability, etc.
Ashish Jha is a faculty director of the Harvard Global Health Institute, and he thinks the laboratory should re-open. Jha, implemented the metrics the FDA approved for its reopening guidelines, and was in awe when he noticed the labs were still closed. In his opinion, the employees have important tasks to work on, and being that they are researchers, they will follow proper guidelines to stay safe and healthy as possible. Employees of the facility have voiced their opinions stating that they are upset by the closing. The extended closing of the laboratory suggests that the staff are ‘non-essential’. For staff, this is disheartening because while many of the researchers are ready to return to work, they are forced not to. Their goal is to gather new data and implement new studies that promote caring for the wellbeing of many.
Priorities have shifted to COVID. NIH, the Canadian Institutes of Health Research, and comparable groups contributed large amounts of resources to research in COVID, which is suitable, but obviously decreased the amount of funding available for other research.
Agencies that provided support globally, have stopped or paused all non-COVID experimental trials. Statistics showed that majority of the trials halted (95.4%) had non-governmental funding.
Most organizations are trying to preserve the research if it has a “direct benefit” for patients, but where to cease is uncertain. Another consideration is whether participants’ extra appointments to clinics are worth the risk of catching the coronavirus. Another aspect is whether health care staff are accessible to continue running trials even with the added burden COVID-19 is putting on hospitals and clinics. As a result, organizations are evaluating whether to close on a case-by-case basis.
What could this possibly mean for #Medtech in the future?
While the FDA is unwilling to open their labs back up, this shows what kind of effect the pandemic will have on advancement of science for years to come. FDA’s lab facilities conduct trials whose main goal is the safety of biologic products, like injections and gene therapies. Presently, the labs are learning new ways to distinguish possibly lethal pathogens in blood donations; design safer gene therapy vectors; and advance vaccines for anthrax.
Most research trials are sponsored by small organizations. The issues will arise when the organizations plan to no longer sponsor the research. Whether it’s related to COVID, or because the research becomes too expensive to finish, they may discontinue it. Currently, researchers have seen a weak connection between the national population-adjusted numbers of COVID-19 cases and the percentage of non-COVID trials stopped by country. Clinical trials have not been fully canceled as the NIH is very open and supportive to help with all the underlying issues going on. They’ve even distributed direction on how to manage trials during COVID-19. Some studies can adapt, however the FDA published guidelines that allow for more flexibility during the COVID-19 pandemic.
On August 3, “Return2Facilities” campaign began allowing employees to volunteer to return to work with the approval of their supervisor. This decision was made after months of planning an effective protocol for staff to return to work and remain safe and healthy. The FDA’s choice is not likely to influence the agency’s work on Covid-19 vaccines. FDA scientists working on Covid-19-related experiments are able to demand exclusions from the reopening policy.
Why Partner with GIRS
When determining your FDA strategies and pathway, it is important to consider reimbursement implications in parallel. Conducting clinical trials is a premier method of testing and validating new drugs and therapies. New drug approval is based on successful trials into the safety and efficacy of new treatments. Clinical trials are being severely affected with disruptions in both new participant enrollment and in keeping existing participants on therapies. However, as #medtech push to proceed with product development and approvals, they are likely to engage even more intensively with regulatory agencies.
It will become as critical for them to also engage with payers at the same time to make sure payers are aware of the different approaches pharma is taking to address those evolving challenges and make sure they are capturing the endpoints that payers will need to make new coverage decisions and maintain existing coverage. They need to keep payers updated and most critical is to get the payers’ buy in on payer-desired outcomes and study design.
To implement successful market access strategies, the GIRS Value Discovery Landscape Assessments® team can conduct a Reimbursement Landscape Assessment to develop payer-desired strategies with clinical outcomes experts, coding experts, policy staff, reimbursement lawyers, and a panel of current insurer medical directors.
For more information, email us at info@girsinc.com or call us at 901-834-9119.
Disclaimer: The information in this blog is based on payer information which is dynamic. It is accurate at the time of posting but should not be construed to be reimbursement or legal advice. CPT® is the trademark of the American Medical Association (AMA).
Sources:
https://www.medscape.com/viewarticle/935922#vp_1
About GIRS
For more than 17 years, GIRS has been assisting medical technology manufacturers with their market uptake and reimbursement strategies so that patients can have access to the care that they need. To implement successful market access strategies, the GIRS Value Discovery Landscape Assessments® team and the Payer Advocacy Compass® team work together to develop and implement foundation reimbursement landscape and payer advocacy strategies to obtain positive coverage, appropriate payment, and innovative payer contracting arrangements to improve market uptake. For more information, email us at info@girsinc.com or call us at 901-834-9119.