WASHINGTON, D.C.—Executing and recruiting clinical research trials at hospitals are linked to thousands of unrecovered costs, and facilities must modify practices to ensure self-sustainability, said Rudi Odeh-Ramadan, Pharm D, of the Clinical Trials Office, Columbia University Medical Center, New York City, during a presentation Sept. 24 at the 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific meeting.
Odeh-Ramadan noted that site investigators sustain costs of about $4,000 to $6,000 during the clinical research process that are never fully recovered.
“To ensure that you have an economically successful research program you have to meet two key factors: study timelines and patient enrollment,” explained Odeh-Ramadn. Because time is money, facilities must expedite and simplify the contract execution process and also ensure that they get the research trial up and running as soon as possible, she said.
“Where do the costs lie for a facility? In executing the trial, recruiting the trial and ensuring compliance oversight from an institutional perspective.”
Odeh-Ramadan said that barriers to contract negotiations and trial execution stem from payment terms and the negotiation of the budget itself. Additionally, she said that hospitals may have difficulty with trial execution because of the need for strict regulatory approval and carrying out the IRB process.
“The bottom line here is that the greater the delays to initiating and conducting these trials, the more financial loss you will incur. When you are negotiating these contracts, you have to ensure that you are capturing the true cost of conducting the research and that you get compensation for the activities you put into research trials,” she said.
Additionally, Odeh-Ramadan said that a facility must be competitive with other research institutes in the U.S., and negotiate a fair market value “to ensure you have a consistent and standardized budget of the site and have some degree of transparency.
"The sooner you can initiate the trial, the sooner you can enroll. Not only do you need to ensure that you can recruit and enroll, but you want to ensure you are retaining those subjects for the life of the study.”
Hospitals will at first be affected by start-up costs and personnel fees associated with setting up the trial, databases and study procedures, said Odeh-Ramadan. "We need to make sure we are capturing these costs.”
Odeh-Ramadan noted that because research pharmaceutical and ancillary fees are non-negotiable, often times when a hospital negotiates its clinical research budget, it tends to downgrade personnel fees and subsidize the high costs of regulatory requirements and the fees associated.
She noted that there are very high costs associated with low enrollment because of the need for the monitoring and follow-up during the entire shelf life of the trial.
“What are the consequences of enrollment? An obvious net drain on resources,” said Odeh-Ramadan. She also said that subject enrollment has been pinpointed the number one reason of a delayed completion of a research trial.
Sites must ensure that they are participating in recruitment initiatives and should establish courses and use social media to enroll patients. Additionally, she said the use of a website to build electronic registries may be helpful.
“From the site's perspective, you have to commit personnel to ensure that regulatory documents are filed, that the trial is maintained and that personnel are there to meet the monitoring visits,” she said. Ultimately, this is a net drain on resources and impairs your ability to get trials in the future.”
Of course, the most costly of all ventures for the hospital is ensuring compliance oversight and ensuring that your site is meeting the strict federal requirements,” said Odeh-Ramadan. “These site infrastructure costs are generally not fully recovered by indirect costs and are not covered by direct costs.”
Lastly, Odeh-Ramadan noted that in 1991, less than 5 percent of the investigators who filed clinical research with the FDA were non-U.S. based; however, in 2003 that number rose to 30 percent.
“The complexity of doing trials and increased expenses from the hospital perspective coupled with less sites in the U.S. means that as an institution you have to ensure you have an efficient use of core resources, are reducing redundant administrative activities, promoting a team environment within the institution, ensuring proper resource