Patient recruitment - continued
Dr. Bertolet suggests that site involvement in protocol planning and design could alleviate many recruitment problems.
“I think it would be very helpful if those of us who are ‘in the trenches’ so to speak, could review protocols before they were put into full play,” he said. “Because the question always has to be asked, ‘Is this doable? Can it work, within these parameters?’ And it’s much better to ask these questions before a study is rolled out than to find problems later that could have been avoided and now require amendments to the protocol.”
Dr. Bertolet recalled one recent study where his site was consulted in the initial design, and a smaller pilot study was conducted at his clinic. “We ended up being the top enroller in the U.S. for that particular study,” he noted.
He further suggests that “brainstorming sessions” on the protocol with sponsors and CROs would be highly productive. “More often than not, when I have a good protocol, I get positive results with my recruitment efforts.”
Drs. Pergola and Bertolet also concur on the need to close the time gap between investigator meetings and study initiations, to take advantage of the enthusiasm and momentum generated by the meetings. Both also agree that contract negotiations and payment should be sped up. Dr. Bertolet suggested that sponsors and CROs who have worked with a certain site in the past might be able to streamline the contract process by using site-specific contract templates. He also recommended that trial sponsors and CROs consider alternatives to online training.
“We’ve had some problems with security systems and firewalls blocking training programs,” he noted. “Having training available on CDs might be a viable alternative, depending on the material and confidentiality needs.”
1. Harris Interactive (Healthcare News), Vol. 5, Issue 6, June 27, 2005
2. ibid
What ICON is doing to accelerate budget and contract negotiations and investigator payments
The problems outlined by Drs. Pergola and Bertolet have certainly been voiced by other investigators working in the clinical trials field. At ICON we have implemented a variety of best practices to accelerate budget and contract negotiation with investigator sites, including:
· Evaluation of the study budget
We compare the proposed study budget with historical data from similar studies to see if it is in line with fair market value, and advise the sponsor if it is out of range. Having a fair budget not only
accelerates the budget negotiation process, but it can also provide higher enrolment than a budget that is well below market value.