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Understand everyone's motivations
Each clinical trial administrator and investigator needs to understand the motivations of all parties involved — including his or her own — before beginning a clinical trial contract negotiation process.
"One main thing in any clinical trial is the principal investigator wants to see if he'll benefit in any way," says Theresa Jacob, PhD, MPH, director of the clinical trials unit and translational research at Maimonides Medical Center in Brooklyn, NY.
"One thing they're stuck on is publication rights," Jacob says. "They're usually eager to publish the results, so publication rights is a huge thing for many of the clinical investigators that I work with."
For instance, an investigator often would like to know if his or her name will be on a study's final paper. This is a negotiating point because some studies only include the names of key investigators, Jacob says.
Investigators also might want to know if they can publish some part of the work or present a piece of the research at a convention.
The other side of the negotiation table has the sponsor who has different goals and motives when it comes to publication rights, Jacob says.
"During contract negotiation, the investigator needs to make sure the contract has what he wants, and if it doesn't, then he shouldn't sign the contract," Jacob says. "That's if it's absolutely non-negotiable. Most of the time there's leeway, and since sponsors are interested in having investigators involved in the study, they'll listen."
Jacob offers these additional negotiation tips:
1. Do your budget before signing the contract.
Investigators often are not aware that various sites have different budgets for the same study because of contract negotiations, Jacob says.
Clinical trial sites should determine their budget for a particular study based on the protocol and their own infrastructure expenses. And then they need to negotiate for payment that would more than cover their anticipated budget, she suggests.
"It's better if you don't lose any money on a study, and it's best to get something out of the study for the hospital or facility," Jacob says. "But you should at least break even."
Investigators sometimes make the mistake of thinking a study will provide have access to the same resources physicians have when treating patients.
"The investigator expects all these things to be done in the study too," Jacob notes.
But including every procedure and detail costs time and money, and a study budget might not have room for frills. So it's best to stick with the protocol's interventions and procedures when both designing and following a budget.
2. Remember the goal is quality data.
Sponsors want high quality clinical data, Jacob says.
"The main objective of any pharmaceutical or medical device is to conduct a clinical trial to collect high quality clinical data and to obtain FDA approval of the product so they can market it," she says.