How Sites Are Managing The Rising Costs Of DCTs
By Life Science Connect Editorial Staff
In a recent conversation with Clinical Leader’s Ed Miseta, decentralized clinical trial (DCT) experts Brad Hightower, CEO of Hightower Clinical, and Karri Venn, COO, president, and chair of the operating board at Centricity Research, discussed the rising costs and associated staffing issues brought on by the proliferation of DCTs.
The Cost Of Implementing DCTs
DCTs exploded in 2020 with the COVID-19 pandemic. Clinical trial sites scrambled to pivot to the new normal of remote and at-home patient care and away from traditional models. Sponsors, CROs, and sites had to adopt new methodologies and protocols to ensure trial success during a challenging time. When DCTs were rapidly adopted, this affected site budgets by adding new costs, including eClinical technology, IT infrastructure support, additional staffing, and increased training time for existing staff. Of those, the most significant cost increases are related to staffing.
“Study coordinators have increased workloads, site staff must be more tech-savvy than before, and sites are experiencing high turnover,” explained Venn. “All of these elements add to the study cost. Also, we’ve started hiring study administrators, which is a new position. Ultimately, as sites, we must think about the support mechanisms that we need to put in place to reduce staff workload and streamline training.”
Multiple vendors mean multiple training sessions for staff, but Venn explains that expecting all site staff to learn every new system is unrealistic. Instead, she recommends that sponsors and CROs look at specific job duties for each position and only require staff to be trained in the platforms they need to know. Traditional study models, in which staff did a little bit of everything, are inefficient in today’s technological environment.
Creative Staffing Solutions Mitigate Costs
Post-pandemic inflation has affected the entire pharmaceutical industry, and sites are no different. Supply costs, salary increases, and staffing shortages are driving up the costs of clinical trials. Also, many trials that were delayed during the pandemic are now restarting, putting higher demand on sites. How can sites mitigate costs?
“DCTs require people with different skillsets than traditional trials,” stated Hightower. “This can lead to increased costs if you don’t already have that skillset on your team. Inflation is affecting all of us, and sometimes, as the site, we feel like we’re at the bottom of the food chain. So, this issue is very sensitive at the site level.”
Venn added that although personnel costs have risen dramatically, they can be mitigated if study coordinators make strategic hiring and workload decisions. For example, DCTs require technologically advanced data management, but hiring dedicated data entry staff costs less than expecting higher-paying staff members to perform data entry. Also, reducing professional employees’ workloads helps retain them in a climate where attrition is high.
Achieving ROI With DCTs
Once sites establish DCT infrastructure and staffing, they see a return on their investment as clinical trials become less expensive. For example, telehealth and remote visits are less costly to manage than on-site care. Paperless consent and data management can save money and staffing costs.
Return on investment (ROI) often depends on how efficiently DCTs are employed. The panelists advised sponsors to consider which elements of DCTs are the most appropriate for their patients and their study to determine which changes are necessary rather than view DCTs as all-or-nothing. For example, remote visits save money, but hiring home healthcare providers may add to expenses. Hybrid trials may be more cost-effective for some studies, while others can save money by entirely relying on DCTs. Sites should work with sponsors as partners to determine the best way to mitigate costs.
“We’re seeing an evolution in what sites do and how they operate,” explained Hightower. “As we expand enrollment to include more DCT patients, we should see enrollment go up, which will yield a net positive. But there can be a disconnect between sponsors, tech vendors, and sites, so we need to continue to work together to find solutions to these new challenges.”