Avoid common mistakes in the CR contract process

Intellectual property can be tricky

The first step to improving a clinical research site's contracting process is for the clinical research director or coordinator to communicate with the institution's legal professionals about the contract, an expert notes.

"If the person reviewing the contract is a lawyer or paralegal or someone else who is not involved in the day-to-day with clinical trial operations then it's very important for there to be communication between meeting those two people or those two groups," says Lucy Robins, JD, attorney at law and legal consultant to the University of Maryland Medical System in Baltimore, MD.

Robins offers this example of why this collaboration is important: "The other day we were meeting with the folks who run the part of our hospital pharmacy that handles the investigational drugs," Robins explains.

"One of the things typically in a contract for the sponsor of a drug study is wording that says, 'If there is any leftover drug at the end of the study, it will be either returned to the sponsor or destroyed by the site, whichever the sponsor says to do,'" she says. "It's almost a reflex to add that the return will be at the sponsor's expense."

But Robins learned at this meeting with pharmacy staff that the destruction or disposition of study drugs can be time-consuming and costly."

There are multiple regulatory requirements for environmental reasons.

"You can't just pour them down the sink," Robins says.

The contract should make clear who is going to pay for the drug disposal, she adds.

"If you spoke to the pharmacy at the site, they might not even want to get involved in doing that disposal of drugs," Robins says. "In this case, it would be very important for the contract to say that we're not obligating them to do so."

If the pharmacy or CR staff are willing to dispose of study drugs in exchange for compensation, then it should be put clearly in the contract that the sponsor will pay for the drugs' disposal, including the costs of extra staff hours and out-of-pocket expenses, she adds.

Robins outlines two other issues that should be addressed in contracts:

* Intellectual property:"Particularly if you are an academic medical center, agreements regarding intellectual property are important," Robins says.

"It's important your principal investigators have the ability to publish the study at a time and in a manner they feel is appropriate," she adds. "It's important that the sponsor cannot hold up their right to publication indefinitely."

Sponsors may understand this, but they often will want to delay publication until all sites have closed out.

"This is reasonable, but you have to make sure the clock starts running and doesn't run too long," Robins says.

Also, contracts should address who owns any intellectual property developed at the site. There might be patentable discoveries about the drug or about the disease. Or there might even be something discovered about another condition during the course of the research.

"Research organizations should have a policy about what they're willing to let sponsors have and what they're not willing to let them have," Robins says. "The way this is written in the contract should be consistent with that policy."

When the person handling research contracts is not an attorney and an inconsistency is found in the intellectual property policy and the contract's wording, then the clinical research staff should ask for assistance from the organization's legal office or from a technology transfer/information technology specialist, she suggests.

"Sponsors are very aggressive in terms of what they want to own, and they'll typically say any invention made in connection with the trial or drug is theirs."

This type of contract language may not have limitations by time or how closely related the invention is to the study, and most organizations would find this to be unacceptably broad language, Robins says.

"The way some of these clauses read, the study drug could be on the market when a doctor who was an investigator in the study comes up with an idea that turns into an invention, and the sponsor's contract wording would have the sponsor owning that invention," she explains. "This is even if the investigator came up with the idea well after the study is over."

• Budget and payment terms: Collaboration between lawyers and study teams again is important when a contract is reviewed for budget and payment terms.

"You have to know what the study team's concerns are," Robins says. "I see a lot of contracts where the payment terms say there will be 10% held back until we've resolved all issues."

Sometimes clinical trial teams will ask attorneys to tighten up this language because a particular sponsor is very picky and will waste hours of the study team's time while going over insignificant details, she says.

"You may want to put language in the contract that says the sponsor has to be reasonable or get specific about what the sponsor can hold up payments for," Robins says. "If your site has done its work then you should be paid, and there shouldn't be an issue."

These kinds of contract changes often are more fact-specific than time specific, she notes.

"Sometimes sponsors will say they'll pay at the end of the quarter, and sometimes that's okay and sometimes that's not," Robins says. "Why should you have to wait until 60 days after the end of the quarter to be paid — that's five months after the study subject's visit to get paid."

Robins leaves it up to the study team to review payment terms. If there is a problem, it might be time to suggest a change.

"If they say they have a good relationship with the sponsor then maybe for a study where they only see two patients a year, the payment terms are not a big deal," she says. "I push for what's important to the study and organization."

Clinical research sites also could address concerns about the holdback terms during meeting with sponsors during contract negotiations. It helps if they have something specific to report.

"They could say, 'This is what happened last time: we didn't get our holdback for two years; your people came in six times and kept going over new issues,'" Robins suggests. "You would have more ammunition to negotiate something more specific, but without that you're stuck with the wording of 'reasonableness,' and you won't get the sponsor to agree generally to time limits."

In general, research sites should negotiate for the points that are important to them and their institution and hire attorneys to review the contracts, Robins says.

"The overall idea is that sponsors generally write the contract to represent their best interest on everything in there," she adds. "I tell people they put everything in the contract for a reason, and you need to read it and understand it so you will know what you're getting into."