Expert offers negotiation strategies sites can use

Asherman's model is basis

Research sites often focus on finding any studies that might fit their patient populations and let sponsors or clinical research organizations (CROs) take the lead in negotiations. But this could be a mistake. Sites could be missing opportunities to build better site-sponsor-CRO relationships, all because they lack optimal negotiation and trust-building skills.

If they were to focus on improving negotiation skills, this would have a positive impact on their communication and contracts with CROs and sponsors.

The key is to approach negotiation with a basis in building and maintaining a mutually-trusting relationship in which each party tries to understand and meet the other party's needs whenever possible, says Barry Sagotsky, MBA, owner of Magnolia Lane Consulting in Princeton, NJ, and a partner with Asherman Associates in New York, NY. Sagotsky has spoken about negotiation techniques at national conferences and bases his strategies on the model developed by Ira and Sandy Asherman, principals of Asherman Associates, who have written numerous articles and edited books about the negotiation process.

Sagotsky offers these suggestions for how to improve negotiation skills and strategies:

• Discuss all of your issues: "Many people don't take the time to discuss all the issues on someone's mind," Sagotsky says. "They focus on the biggest issue and then start jumping in and working on that one, overlooking a lot of opportunities for trade-offs and concessions later on."

Also, clinical trial site investigators and negotiators should encourage sponsors and CROs to discuss all of their issues.

"You can explore and understand the other party's needs, interests, and objections without agreeing with them," Sagotsky says. "When you do try to understand their needs, you have a much better chance of having them interested in understanding your needs and motivations."

This discussion of each party's needs and interests answers the common question of "What if others are not playing the same way I am?"

Negotiators who spend time figuring out the other party's interests are more likely to figure out what is the common ground between them, Sagotsky says.

"This can lead to a compromise or collaboration," he adds.

For example, a CRO could push hard on price during negotiations with a research site and win this point. But if the CRO hasn't learned more about the research site's resource and economic pressures, then the price it won might be at the expense of service delivery, Sagotsky explains.

"The other party is going to try to deliver a service that is in line with what he is being paid," he adds.

• Negotiate X based on delivery of Y: From a CRO's or sponsor's perspective, it can be beneficial to negotiate a specific price that is based on the successful study enrollment at specific time points.

From the trial site's perspective, this type of negotiation might satisfy the site's need to have control over certain aspects of the study enrollment. For instance, the negotiation might go as follows: "We'll guarantee a certain level of enrollment if we can control the screening at the site, which will cost you extra," Sagotsky suggests.

When research sites are negotiating on the issue of study enrollment they are more likely to meet their objectives if they understand and address the sponsor/CRO's needs and interests, he adds.

• Ask for participation in protocol development/revisions: A fairly common issue with investigators involves inclusion/exclusion criteria.

"People at sites want to be part of that discussion of how to appropriately have inclusion/exclusion criteria relative to the statistical results the company needs or the number of randomized subjects that the site or CRO need to finish the study on time or ahead of time," Sagotsky says.

Both sponsors and investigators want to make sure the right people are enrolled in a study and that subjects will stay enrolled until the study is completed. But the investigator might have a better idea of how certain inclusion criteria or procedure requirements could negatively impact that enrollment and retention.

"If these factors are not discussed or thought through when the protocol is designed, then it could have implications for enrollment and future negotiations," Sagotsky says. "An investigator might say, 'Yes, I have the population, but they won't put up with this procedure because ...'"

An investigator might be able to say during negotiations, "You can get the results you need to prove your claim with a different set of inclusion/exclusion criteria."

Most studies' inclusion/exclusion criteria can be up for negotiation, including both medical and clinical operations. And it's an area that should be brought up early in negotiations rather than waiting until the study begins and problems crop up, Sagotsky says.

"If one group says, 'This is my responsibility, and I don't need anyone else's input on it, then it's a systematic piece that makes negotiation tougher,'" he adds.

• Structure your site's systems to make negotiations easier: "You may have overriding organizational and structural systems and issues that make negotiation easier or more difficult," Sagotsky says.

For instance, a site that has a cross-functional team is in a good position to be flexible when studies call for labor-intensive procedures. The cross-functional team would make it easier for the site to handle weekend study visits if needed and give that particular site a bargaining chip that could be used for other concessions.

"This is the kind of thinking that happens with a high-performing team where people focus on the organization and results of the work rather than on the pieces of the organization," Sagotsky says.

Research sites that have roles and responsibilities put into silos, divided between medical and operations, have less negotiation flexibility.

"There is less communication and trust in organizations with silos," Sagotsky says.

• Make contingencies during negotiations: It pays to know your own, and the other party's, top priorities and objectives. With this information, a clinical trial site can add concessions with contingencies to negotiations.

For example, a CT site negotiator could say, "I'll give you this if you give me that," Sagotsky says.

Also, contingencies can be given expiration points.

"Someone might say, 'If you refuse my offer of a concession then my concession is no longer on the table,'" Sagotsky says. "Anyone has the power to do that."

Here's an example of how this might play out:

One negotiator says, "If I give you this dollar amount, will you give me this report at the times I specify?"

The other party says that he cannot give the information at those particular dates.

"No? Then I'm no longer offering that dollar amount. But if I give you this particular information at these times, will you be able to give me the reports at the times that I need them?" The first negotiator replies. "I still need the reports on time."

The key is to come back to your chief objectives, adjusting offered contingencies to get there.