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Contentious? Maybe. Dialogue? Definitely. That is what Nedra Rhodes, MA, Lead Contracts Specialist, North America for REGISTRAT-MAPI told Applied Clinical Trials what she expected from the session she is speaking on at the DIA 46th Annual Meeting, Monday, June 14 at 1:30 to 3 pm.
The session “How Investigator Budgets Impact Patient Enrollment and Retention: Improving Processes to Increase Productivity,” is chaired by Daniel Ulrey, MBA, President and CEO of Midwest Clinical Support. In addition to Rhodes, who is the CRO representative on the panel presenting “Contract and Budget Negotiations and the Importance of Process,” there will be two additional presentations: “A Site Perspective: Overcoming Obstacles to Successful Enrollment,” by Jeffrey Adelglass, MD, President and CEO, Research Across America, and “A View from a Sponsor: Identifying and Rewarding Investigative Sites,” by Ira Spector, MBA, Senior Vice President, Global Development Operations, Allergan.
“I think part of the value of DIA is the opportunity to share perspectives and discuss solutions,” said Rhodes. “I think it’s rare that you have all these areas—the site, sponsor, and CRO together to talk about it. I think it will be contentious. It’s a contentious subject. We may ruffle some feathers, but the value is in the exchange.”
Specifically, Rhodes plans to present the obstacles that she has come across in the world of contracting and fast study start-ups. “I think the sites have frustrations related to payments. I think sponsors have frustrations related to timelines.” To address both sides, Rhodes will outline the steps required in a contracting process and shed light on the process so that each can see where the other is coming from. With this knowledge, the parties can be prepared to better move the contracting along.
For example, sites that can document and support their claims for a higher payment are usually in a better negotiating position come fast-tracking contracts. “Document your internal costs in a spreadsheet,” recommends Rhodes. “Review the protocol and the feasibility on the front-end, so the site is aware of its budget needs and can ask for higher reimbursement if there is a higher protocol burden.”
Documenting isn’t meant to be another hurdle to jump over for the site. Nowadays, sponsors have extra external forces at work, specifically, federal anti-kickback laws, and other regulations they have to address. “Sponsors have to stick to their SOPs. There are a lot of regulatory requirements that shape how they formulate reimbursement amounts and structure payments” explained Rhodes. For sites that can demonstrate fair market value, workload cost per protocol, and do this in an organized manner, it helps the sponsor.
“Sponsors want to reimburse fairly and appropriately,” noted Rhodes.
In contracts, Rhodes noted there are sponsors who prefer the CRO act as their agent, and others who prefer to keep the signing authority in-house. In either case, the CRO can help the negotiation process based on experience of seeing both sides. “We are effective on the soft skills. We really have to understand what a site’s needs are. We have to know what questions need to be asked to keep the contract process moving. We ask the ‘why’s’.”
Rhodes is confident that between her presentation, and her co-presenters, attendees will not be disappointed. As the site representatives, Ulrey and Adelglass bring a wealth of experience, as well as metrics, and “won’t be shy” about addressing the meatier issues. Spector’s sponsor view is something Rhodes feels will also bring a needed perspective, something that lacked at last year’s similar session.
For REGISTRAT-MAPI in particular, as a CRO specializing in late phase studies, Rhodes is seeing a definite increase in their services for postmarket study requirements. With the regulatory framework changing, Rhodes says sponsors are increasingly concerned how they navigate this CER, evidence-based, post-FDAAA landscape.
And in the contracting process, she believes that REGISTRAT-MAPI can educate the sites in the late phase arena. “Many times [sites] look at the [payment amount] and they say ‘that’s too low.’ But they haven’t looked at the protocol. We can be upfront and communicate why it’s not like their other Phase II oncology studies. Earlier phase protocols are much more difficult,” explained Rhodes.
“It will be interesting,” concluded Rhodes. “There is not one big epiphany answer. Not a one-size-fits-all process that we are dealing with. The answers lie in communicating, being proactive, watching trends and having clear processes.”