Well-known clinical trials challenges, such as delayed start-up, subpar recruitment/enrollment, and technology silos, have been exacerbated by the COVID-19 pandemic. The U.S. is among the top 10 countries with the highest COVID-19 deaths per capita and by case count1. Certain states have had to deal with natural disasters, such as wildfires and hurricanes, or civil unrest and/or mass violence while also being in a COVID-19 hotspot. To address the financial loss hospitals have encountered as a result of COVID, hundreds of hospitals furloughed workers2. and many of these have already brought back furloughed employees3. These hospitals include regional hospitals, hospital networks and academic medical centers (AMCs). Research centers are now operating in the new normal â€“ inclusive of virtual visits, new safety measures, work-from-home, remote monitoring, and providing greater access to clinical data. What strategies did research centers implement to promote financial sustainability given financial pressures and exacerbation of old problems?
Exacerbation of Underlying Problems and Unexpected Workforce Demands
Amongst the top struggles prior to the pandemic were poor turnaround times during start-up, lack of expertise for conducting certain start-up analyses, siloed technologies, decentralized processes, and funding research infrastructure. Institutions that struggled with one or more of these issues saw an exacerbation during the pandemic that required focused attention.
Beyond the underlying problems that previously existed, rolling COVID-19 hotspots impacted what and how institutions carried out clinical research processes. With mandatory or rolling time off and reallocation of staff to COVID-19-related activities, institutions witnessed further slowing in turnaround times for start-up activities and reduced support for non-COVID-19 research. Prioritization of COVID-19 trials contributed to a 57% decrease in overall contract turnaround time for these trials; however, for non-COVID-19 trials there was a 13% increase in standard timelines.4 Institutions were previously accustomed to executing contracts within 30-60 days, now sponsors seek a turnaround within a few days for COVID-19 trials. One study realized an 80% reduction in turnaround time (completion within 2 days) for both a Confidentiality Disclosure Agreement (CDA) and a Clinical Trial Agreement (CTA)4. Furthermore, Sponsors may expect COVID-19 trial research data within 24-48 hours and request a much higher volume of participants from institutions that are in heavily impacted geographic areas. The new normal in study start-up and study execution imparts an unexpected workforce demand on sites.
Strategies for financial sustainability
Institutions are clearing hurdles and finding opportunities during this crisis to meet new demands and secure sustainability.
Dedicated staff to recruit and educate on new COVID-19 safety measures
To address the additional workload placed on research teams due to additional COVID-19 precautions, some institutions are supplementing their teams with temporary staff who can recruit and educate potential trial participants. This strategy allows permanent team members to focus on activities that are in line with their role and expertise instead of reviewing masking, parking and new safety requirements which are items not typically covered in study budgets.
Temporary external expertise to speed start-up
To support over-extended research teams, especially those with studies that were previously suspended by the pandemic, some institutions are temporarily outsourcing all or parts of the start-up process, such as contracts, budget builds, or coverage analysis. This speeds study start-up and adds a layer of expertise in areas where sites perhaps struggled previously. This outsourcing strategy is also a way to test quality and establish trust with the vendor. Moreover, for institutions that are financially constrained, outsourcing activities where sponsors cover most of the expense can reduce the financial impact on the institution.
Permanent outsourcing (less common, but sometimes necessary)
A less common approach is for institutions to outsource across several research activities to easily scale up or down depending on need. This could involve replacing entire teams or administrative departments when its function has limited value to the institution, and/or it has become a cost center. In this case, the responsibilities of employees are shifted into areas that add greater value for the institution. While this is a less common approach, it brings significant quality, speed and value to the institution at a fraction of the cost (certain outsourcing models pass 90% of cost to the sponsor).
Sponsor-paid planned research coordinator augmentation
Another area where institutions have implemented creative solutions is in timely submission of clinical research data. Timely review of clinical data is necessary to determine efficacy and safety of the investigational product. Delays in data entry could snowball when research coordinators are stretched thin or are unavailable. Therefore, certain sponsors are now cover outsourcing expenses beyond those negotiated in the budget, to ensure timely access to safety data. While this is often done at the outset of a trial; it may be added when pandemic-related interruptions make it necessary to add mid-study.
This strategy requires a change in thinking. At the outset, a research site may unfortunately assume that receiving the â€śhelpâ€ť is an indication of personal failure or lack of trust by the sponsor in the site. They may refuse the resource and believe â€śwe can do it on our ownâ€ť, only to accept the help once they are unable to meet new demands on the site. Whereas sponsors primarily invest in the sites that they trust have the study population and have a high potential to succeed in trial execution.
Ad hoc services for unplanned disruptions
As institutions grappled with decisions about how best to sustain, reopen, and continue research, workplace safety, the health of their workforce was of paramount importance. The Occupational Safety and Health Administration (OSHA) received thousands of complaints about coronavirus-related safety concerns â€“ the majority of which have come from healthcare workers6. In other words, employees fear for their safety.
While disaster plans cover a multitude of contingencies, and some may include outsourcing certain activities, when is the right time to trigger that help? How do institutions decide when to augment their staff with outside resources? Sponsors might consider providing additional funding mid-study for these resources as an â€śinsurance policyâ€ť on their investment. But research centers also considered proactive solutions as an insurance policy for their own business sustainability beyond the pandemic.
With this in mind, research leaders established agreements for ad hoc resources within their departmental budgets for the current pandemic-related need(s), and as part of their go-forward strategy. This strategy gave research leaders the ability to utilize their staffâ€™s talent on areas that require higher expertise instead of distracting them from important obligations. This change speeds completion of the unplanned work as the new resources is 100% on task instead of splitting time with other responsibilities. And time matters â€“ whether it is to make a study available to participants, to communicate COVID-19 related amendments, or to update location changes in consent forms across hundreds of trials. A pre-set contingency plan that includes a budget for â€śunplanned disruptionsâ€ť helps ensure smooth ongoing revenue generating research activities.
The pandemic as a catalyst to drive technology changes
Institutions are removing layers of bureaucracy surrounding access to appropriate technology and data, while still ensuring integrity, ethics and compliance. From securing remote access to electronic health record, to implementing electronic regulatory binders, econsent, clinical trials management system supported patient portals, and more, the pandemic has served as the catalyst to secure changes faster at some institutions. The inclusion of virtual visits, adapted consent process, and access to data to appropriately monitor the study are vital (at minimal) when in-person visits are not feasible. The ability to implement technology changes or expand use of the technology (if they already used it) had a significant impact on the ability to continue research activities and continue generating revenue.
Diversity and Inclusion Practices for Financial Success
The realization that failure to recruit Black and Latino people into clinical trials at the same level as they are affected by the disease could delay progress and potentially approval of a COVID-19 vaccine5 is concerning. Institutions are questioning their hiring practices and the representation of minorities across the life cycle of research. Do the investigators and research staff include people that look like the patient population they serve? Do the IRB office and its committee members reflect the diversity of the community? Does the DSMB, student body, biosafety committee, etc. include the voice of those that have historically been disadvantaged in the US? Ensuring minorities are part of the entire clinical trial process is not only the right thing to do, but also secures financial sustainability in research as sites with high minority enrollment will be sought after by sponsors who seeks equity in racial representation across their trials. Sponsors will cover expenses of enrollment assistance, beyond the negotiated budget, to support a study specific strategic plan that boosts enrollment. There is no one-size fits all solution to increase diversity in clinical trials, as regional and population varies across the US, but at minimum, institutions are evaluating representation across clinical trials and exploring multiple solutions â€“ both internal and external â€“ to increase diversity in participation and their financial success.
The COVID-19 infection rate is at above 40,000 daily cases in the U.S. (at the start of October 2020) and physicians reported that clinical care visits have yet to reach the pre-pandemic level7. The financial impact of the pandemic on research centers (institutions) cannot be overstated. Research centers adapted solutions and workarounds to mitigate the local impact of the pandemic to help ensure endurance on their research programs. While some solutions fall outside usual business continuity plans at some sites, research leaders implemented solutions that were formerly off the table. Temporary, ad hoc or permanent changes in staff are at the core of some of these solutions. New expertise, technologies and an introspective look at their diversity and inclusion practices are amongst others. Both sponsors and research sites want to ensure that clinical researchers have the resources necessary to conduct investigations at the highest standards and potentially lead to the approval of treatment or vaccines for patients â€“ and that is a shared goal we all can agree on.
, VP, Strategic Site Services, WCG
Call to Action: WCG is the worldâ€™s leading provider of solutions that measurably improve the quality and efficiency of clinical research. Comprised of two divisions â€“ the industryâ€™s first central IRB â€“ WIRB-Copernicus IRB – and first clinical services organization, WCG enables biopharmaceutical companies, CROs, and sites to advance the delivery of new treatments and therapies to patients, while maintaining the highest standards of human participant protection. WCG delivers transformational solutions and services that stimulate growth, foster compliance, and maximize efficiency for sites, sponsors, and CROs. To learn more about how WCG can support your organization, email us at email@example.com.
- Craig, Jessica. Charts: How The U.S. Ranks On COVID-19 Deaths Per Capita â€” And By Case Count. NPR. August 5, 2020.
- Paavola, Alia. 266 hospitals furloughing workers in response to COVID-19. Beckerâ€™s Healthcare. April 7, 2020.
- Gooch, Kelly. 24 hospitals bringing back furloughed employees. Beckerâ€™s Healthcare. August 2020.
- COVID-19 Trial Insights from the WCG Knowledge Baseâ„˘.
- Cohen, Elizabeth, Vigue, Dana. COVID-19 vaccine trials have been slow to recruit Black and Latino people â€” and that could cause a delay. CNN-WTOPNews. August, 16, 2020.
- Whoriskey P, Stein J, Jones N. Thousands of OSHA complaints filed against companies for virus workplace safety concerns: the complaints offer a snapshot of the fear experienced by the slice of working Americans compelled to be at work even as the majority have been urged to stay at home. Portland Press Herald. April 16, 2020.
- Bean, Mackenzie. In-person visits have yet to rebound, nearly half of primary care clinicians say. Beckers Hospital Review. September 1st, 2020