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Master documents, 'score cards' are latest trends in trial contracts
Negotiation process is faster now
Sponsor-initiated clinical trial agreements are well-worn pathways, so it makes sense that the latest trend of recent years is for research sponsors and research institutions to use master agreements.
"Why go through a line item negotiation over terms that are really well understood?" says Jim Kiriakis, director of industry contracts at the University of California, San Francisco (UCSF) in San Francisco, CA.
Research institutions typically have their own policy perspectives that are quite familiar to sponsors, and industry sponsors have been doing these types of agreements for 60-70 years, Kiriakis adds.
The contracting process has contributed to a very slow research pipeline in recent decades, and sponsors are beginning to realize this trend has to be reversed.
"You can't take a year negotiating a contract," Kiriakis says. "You have to do it in two weeks."
To make this process work, templates are necessary.
Both sponsors and clinical trial sites need greater consistency in the budget and contracting negotiations, Kiriakis notes.
"Uniformity and replicability are the main things from my perspective," he says. "Master contracts are the smart way to do business; why renegotiate individual contracts with sponsors?"
Master contracts save time and contribute to consistency.
"It can save hours," Kiriakis says. "Instead of having to read a 20-page contract and going back to fix stuff, you have legal items that are agreed upon in advance, and you just add the starting date, end date, dollars, who the principal investigator is, what the protocol is, and you're done."
From a clinical trial site perspective, master contracts bring predictability to the negotiation process. Investigators will know before the agreement meetings begin what a particular sponsor expects and provides in most of the negotiable terms.
"Sites have gotten more sophisticated about managing their operations financially; they understand they need to cover their costs," Kiriakis says.
It makes sense to have a contracting template agreement in place so that the time spent in negotiations can be directed to the most important points, including payment and timelines.
Another recent trend among sponsors is the use of scorecards, Kiriakis says.
"Recently, I meet a sponsor who had a list of all the trials we had conducted in the past three to four years," he notes. "The sponsor kept a scorecard, a report card that included accrual data, the number of patients on the study, and the actual number relative to the forecasted number."
The sponsor could easily identify how long it had taken a particular clinical trial site to accrue subjects and then compare its outcomes with what was expected.
Pharmaceutical and biotechnology companies, along with clinical research organizations (CRO) have begun to collect clinical trial site metrics because it's a survival tactic.
"They have to live up to investor expectations on Wall Street, and time is an asset," Kiriakis says. "You have to get the drug to market."
So sponsors want to know whether a particular clinical trial site can deliver quality on performance, timeliness, and subject accrual, he adds.
"Can you run the protocol accurately? Can you provide a deliverable, which is the whole purpose?" he says."People are measuring efficacy and performance and results as they should."
When the clinical trial industry's statistics suggest the entire industry has been slowed by inefficient site selection and time-consuming processes, including the budget negotiation process, it seems reasonable to wonder why these changes haven't occurred years or decades earlier.
"My guess is because this is such a relationship- and reputation-based industry," Kiriakis says. "If you're a sponsor, you want the investigator with the name and known track record."
Sponsors will say they've returned to do business with investigators they know can do the work, so they don't have to measure the CR site's performance, he adds.
"They're most interested in knowing their investigators extremely well," he says.
But as the CR industry has become more competitive, and the regulatory environment has made navigating new products to market a bigger challenge, this atmosphere has been evolving.
The industry is moving from an acceptance of long product cycles to a growing drive to move investigational products more quickly along the pipeline, Kiriakis says.
"With the dynamics of competition in the industry and the ebbing product portfolios, there's more pressure to do things quickly," he adds.