Running an efficient clinical drug trial
There are some things you can count on when conducting a clinical drug trial:
- Every financial assumption you made going in will be tested and retested, and many will be proved wrong;
- The sponsor will face great pressure to manage costs and cash flow to reach the next project milestone and show backers their money has been invested wisely;
- Sites will lack the infrastructure to effectively handle the administrative load and will be very sensitive to how quickly they get paid; and
- From first patient in to trial close-out, forecasting investigator payments will be a constant challenge.
These realities, as old as clinical research itself, prompted my company to develop the first automated investigator payment and forecasting service, PremierPlan, which is still in its introduction phase.
First step: investigator payments
With thousands of interdependent actions and transactions revolving around the biggest variable of all—people—clinical research is an unavoidably complicated endeavour. That’s why we developed an investigator payment service called PremierPay to ensure that investigators get paid accurately and on time and expend less effort in the process.
We created an automated payment forecasting service called PremierPlan, now being deployed across our trials and offered as a standalone service to other contract research organisations (CROs) and to sponsors seeking to make the most efficient use of their money and time.
Investigator payments account for about half the cost of a typical study—more when we’re dealing with highly complex indications such as cancer. With the advent of more targeted medications, trials are getting longer and more costly. The highest investigator fees by far are in the US, where numerous compliance requirements complicate the payment process, but complexity is greatest in global trials, where complicating factors can include currency exchange, regulatory data reporting such as the US-mandated Sunshine Act, financial reporting across borders, contracting party issues, and value-added taxes.
Spreadsheet-based processes
The sponsors we most often work with are small, thinly staffed biotech companies that have little financial infrastructure and often rely on scientists and clinical operations staff to forecast payments and perform other essential financial and administrative duties. To do this, they use manual and cumbersome spreadsheet-based processes that offer little ability to forecast how all that money is spent.
Biotech startups, meanwhile, are under constant pressure from investors to reach their next product milestone. Some of these companies are so small that the entire enterprise depends on a single compound, so they really need to maintain a high degree of situational and financial awareness.
“Armed with the best data, all parties can make better decisions faster, strengthening CRO-sponsor relationships and helping retain and motivate high-enrolling and top-performing sites.”
What’s more, clinical trials are not linear events, but change constantly. Reality often differs from even our most carefully engineered assumptions, driving demand for a tool that allows us to quickly provide updated financial projections. Investigator sites, meanwhile, are small businesses highly dependent on timely receipt of grant payments to maintain cash flow.
More than 70% of these businesses say delayed payments cause them financial stress, and that in turn can compromise their ability to retain the qualified personnel they need to deliver high-quality results. These investigators and their staff spend significant time tracking their fees and requesting payment, time that would be better spent focusing on their real priorities: recruitment, treatment, and care of their patients.
Word gets around, too. Key opinion leaders in the investigator community won’t hesitate to talk about a negative experience they’ve encountered with a sponsor or CRO, so it pays to maintain a positive reputation within the drug development community.
Process, not people
The clinical research industry has never done a terrific job of efficiently managing trial data. These activities historically have been spread throughout the CROs’ and sponsors’ organisations, with little effort made to consolidate maintenance and administration of the information. Our default approach to dealing with overwhelming data has been to add people, an inefficient and ineffective answer to a problem that demands an automated solution to keep track of numerous moving parts.
Maintaining sponsor, site, and CRO investigator budgets in real time and in one place provides easy access to current information and allows sponsors and CROs to constantly assess trial expenses based on factors such as patient enrolment, enrolment timing, number of sites, activity costs by site, and individual site performance.
Continually updated analysis and immediate visibility of budget-v-actual variances facilitate forecasting of expenses based on actuals, improving cash management and preventing over or under-requesting of funds.
Armed with the best data, all parties can make better decisions faster, strengthening CRO-sponsor relationships and helping retain and motivate high-enrolling and top-performing sites. And smoother-running trials ultimately help get valuable new products to market faster.
Positive market reaction
Wrangling data has been a time-intensive challenge since CROs first emerged three decades ago, but only recently has much attention focused on systematically addressing the need.
Optimised data visibility, maximised productivity, minimised surprises, and speedier introduction of new products: everyone benefits from an efficiently run study—sponsors, CROs, trial sites, and most of all, patients.
Charlie Nicholson is chief financial officer at Premier Research. He can be contacted at: charlie.nicholson@premier-research.com
