Tackle the beast of study delays following these principles
Tackle the beast of study delays following these principles
Know your own budget, chief solution
Study delays continue to accelerate costs of conducting clinical trial research and are a problem for clinical trial sites, as well as sponsors.
When studies are delayed for any of the common reasons, including a study population becoming unavailable or unrealistic inclusion/exclusion criteria, both clinical trial sites and sponsors are impacted financially, and the quality of research becomes an issue, says Christopher T. Speh, MA, MBA, an independent consultant to pharmaceutical companies. Speh founded a clinical research organization (CRO) Resources Solutions Inc. of Research Triangle Park, NC, in 1992, and sold it in 2003 to the Constella Group of Durham, NC. Speh has spoken at national conferences about reducing study delays.
"The recovery from study delays is much more expensive than the anticipation," Speh says.
Sites, CROs, and sponsors all have a responsibility to conduct real time analyses, develop mapping plans, and maintain accurate budgets in order to improve the timeliness of clinical trial research, Speh says.
For example, sponsors and CROs need to make certain the specific study requirements written by the sponsor are both realistic and followed out, Speh says.
Clinical trial site professionals have the scientific and medical knowledge to review the protocol and make sure that what they're seeing with potential subjects and study accrual are reflecting the actual study needs of the sponsor, Speh explains.
"Also, it's incumbent on the CRO working with the sponsor to make sure the specification does reflect that requirement and reflects the protocol the site can undertake and be successful with," Speh says.
CROs might not have the medical expertise to challenge protocols in depth, but they can pay close attention to the mechanics of a study and note where expectations were realistic, Speh says.
"If we thought the sponsor was unrealistic about accrual or ramping up sites, we would bring that information back to the sponsor, whether we were asked to or not," Speh says.
"We would tell them what the study objective was and whether it was achievable, and our feedback was oriented at assuring that realism is built into these study plans," Speh says.
From the site's perspective, it's extremely important to have thorough knowledge of clinical trial costs, Speh says.
"Sites often have a general feeling, but they don't really know what the cost of research is for their site, so they're often not in a position to challenge a sponsor with solid data," Speh says. "Then they may take on a study that is unrealistic in terms of costs."
Naïve sites are particularly prone to taking on studies that may cost them more than what the sponsor has agreed to pay, he says.
While the ideal situation would be for sponsors to keep data and know who the better sites are and award contracts to the ones who are known to produce quality data, even if they do cost more, that's not the way it often works, Speh says.
Some sponsors focus more on the pricing issues than on the delivery of quality data, Speh says.
"We were fortunate as a small CRO," Speh notes. "We tended not to work with major production, cookie cutter clinical trials, and so we developed very solid relationships with our sponsors."
Speh's CRO had active interactions and conversations with sponsors about what would work and what wouldn't.
However, cost remains a chief driver of contracts for some sponsors, he says.
"Part of the reason why profitability is so difficult to obtain in the site business is because of modernization of service," Speh says. "We've increasingly seen site service as a commodity, and you basically bid it out to the lowest bidder."
For some sponsors, the contracting process is the primary means for selecting vendors, and cost is the predominant factor, Speh says.
"You do find that quality of the study goes down when cost is the main factor, because sponsors then are working with more naïve sites," Speh explains.
Naïve sites are the ones more likely to accept the first offered contract price because they want to build up their business or they don't have a realistic handle on their trial costs, he says.
On the other hand, if a site can demonstrate it can deliver subjects on time then the sponsor will pay for it, Speh says.
"Quality is good for business and it leads to profitability for the sponsor and the site," Speh says.
"The other issue is cash flow," Speh says. "The more naïve sites don't know their costs, and they don't project their cash flow, so they may struggle."
While sponsors have moved to more centralized contracting, this hasn't had the result of improving sponsors' knowledge about site performance, he notes.
"The pace often is driven by so much work going on that it's not just possible to gather all of the information and have it available to the next team putting together a study specification," Speh says. "However, sponsors recognize that the more information they have about potential vendors, the better off they'll be."
Alternately, sites are in a good position to know and market their own data to sponsors, he says.
Sites should know their own costs and, more specifically, how those costs are tied to milestones in the study, which would predict the cash flow situation, Speh suggests.
"For sites to protect themselves and to help the sponsor achieve a successful study, they should make sure there are very clear milestones in the contract, and this is where study mapping comes in," Speh says. "The milestones map back to the critical elements of study plan and design, so the site receives financial incentives to put its best efforts against the elements of the plan, and typically that will be the accrual rate."
Clinical trial professionals need to take a close look at the reimbursement methodology to make certain they know where the trigger points are, and then they need to map it out to learn whether the cash flow is something they can live with, Speh suggests.
"It doesn't do any good if six months into a trial you are profitable in principle, but you still don't have cash when you need it to pay the bills," Speh says.
Ideally, sites will learn to become differentiated and specialized in certain clinical trials that attract sponsors and make it more likely they will meet accrual goals, Speh says.
Once a site does this then it will be easier to find sponsors who know what it is that they do very well, he adds.
"Identify the niche areas where you have particular capabilities," Speh advises.
This is an increasingly important strategy as U.S. sites begin to compete with lower cost international sites, which often have faster subject accrual times, Speh notes.
"There is real potential in this country for sites that remain domestic, but they're going to have to work harder at differentiation," Speh says. "If you're just one of the pack, achieving profitability will be a challenge."
Another way to improve their success in subject accrual and to reduce study delays is for sites to know their own capabilities and limitations, Speh says.
"Sites go into research and see the potential revenue and there's a blinding effect of their own limitations," he says. "Sites should do assessments of their own potential subjects."
Sites are the best judge of whether a sponsor's accrual expectations are realistic, but this is true only if they know their own limitations, Speh says.
"I think most sites that engage in clinical research really don't have a comprehensive database of their subjects that can be screened in a very efficient way to determine how successful they can be in a study," Speh says.
While sites have the data available to make this assessment, they often fail to view the information from a business perspective, he notes.
"It's a terribly unforgiving world for a site that takes on a study and does not deliver it for whatever reasons," Speh says. "With as much competition as there is out there, being able to demonstrate you can deliver subjects can lead to profitability."
Study delays continue to accelerate costs of conducting clinical trial research and are a problem for clinical trial sites, as well as sponsors.Subscribe Now for Access
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