The global pandemic, in its early stages, brought a hailstorm of challenges to businesses, including the business of conducting clinical trials. While our Westat colleagues have successfully conquered those challenges for our clients, new obstacles triggered by a pandemic-inflicted economy are threatening clinical trial research today. Initial funding, staff shortages and supply chain disruptions are among the factors compromising clinical trial progress and the advancement of new therapies.

Small biotech and pharmaceutical companies, with their more limited resources, are especially feeling the pain of impeded clinical trial research. With finite monies, funding clinical trials or attracting investors is especially challenging. Helping sponsors address lack of funding and other hurdles is where working with a trusted contract research organization (CRO) with experience and a reputation for problem solving can make all the difference.

Easing Investors’ Jitters

Today’s investors are especially nervous about putting their money into projects with unpredictable outcomes. Heightening awareness of a sponsor’s drug or therapy and the potential to treat or cure a disease is critical to attracting investors. Westat can 1) provide data analyses from early clinical testing for presentation to investors when raising money for later phase trials, 2) help prepare presentations for scientific meetings, and 3) develop a data-rich manuscript on the drug safety and efficacy for submission to a scientific journal. If published, the journal article not only brings attention to the drug but also strengthens the sponsor’s ability to share its potential to investors.

Eliminating Staffing Challenges

Today’s labor shortages are a residual effect of the pandemic and seem intractable. They present yet another hurdle affecting both sponsors and clinical research sites. Vaccine developments prompted a hot labor market for clinical research professionals, resulting in a shift of staff from sites to the front line. Thus, clinical sites faced a revolving door of new and less experienced professionals, who must be trained to implement new protocols and conduct FDA-compliant studies.

Westat’s comprehensive trainings for site staff tackle this issue. They cover monitoring data and source documentation, protocol specifics, and patient confidentiality while providing overviews of data management, regulatory requirements, and associated systems.

For companies forced to trim staff, or that have limited staff to support multiple studies, we can provide critically needed expertise as well as professionals, including clinical research associates (CRAs), data managers, or statisticians, to offer skills and experience where needed.

Managing Resource Gaps and Supply Chain Disruptions

 Inadequate staffing is also affecting other key collaborators essential to clinical trial research such as vendors. For example, because competing studies and limited staffing can lead to a delay in receiving test results from laboratories, our project managers carefully plan for sample collection and testing with the team and follow up with sites and laboratories to ensure shipments, processing, and reporting are efficiently managed.

Supply chain delays can hamper delivery of trial supplies and halt clinical trial enrollment. To reduce this risk, we work closely with the sites and drug/laboratory kit suppliers to keep abreast of lead times, inventory, enrollment, and expirations to ensure that supply shortages are alleviated. Maintaining detailed tracking reports helps identify potential problems, so they can be addressed before enrollment goals are compromised. And throughout the study, open communication with managers, sites, and vendors is key to ensuring the clinical trial progresses smoothly.

Advancing Innovative Therapies Is the Goal

Today’s economic climate has intensified the challenges facing the clinical trials industry. Westat’s dedicated CRO team of biostatisticians, clinical research associates, data managers, regulatory associates, and study managers stand ready to help sponsors overcome those challenges. Our innovative solutions support delivery of cost-efficient, productive, and highly successful clinical trial programs. We believe with the right partner, small biotech and pharmaceutical companies can thrive in this environment and bring their innovative drugs and therapies to market successfully.

Contributed by Christine Anderson, PhD, and Jennifer Bryant, MPA, CCRP, both of Westat’s Clinical Trials Area.