Are large sites—hospitals, academic medical centers—getting all the trials, while smaller sites continue to fight for the work that’s left over?
That’s what results of a recent survey by Clinical Research Site Training (CRST) seem to indicate. The nearly 20-year-old site-training firm surveyed 500 U.S. sites in December 2010, finding that 66% of large sites say they have won more trials in the last three years. Smaller sites weren’t asked specifically, but anecdotally many small and medium-sized sites reported fewer trials in recent years.
“Like in all other areas in our society, there’s consolidation going on,” said Lester Levine, founder and president of Philadelphia-based CRST, which conducts a similar survey every few years. “Hospitals are merging, and sponsors are going to larger organizations to get more subjects.”
Responses came from large organizations such as Mayo Clinic and Johns Hopkins, hospitals including Rush Presbyterian and the Hospital for Sick Children, and multi-specialty and private practices.
Another surprising result: sites aren’t turning to the Internet as much as thought.
“Both investigators and study coordinators don’t use the Internet to get information,” said Levine. “It’s a combination of not being aware of where they might go and, even if they are, they don’t spend much time going there.”
The survey showed those at sites using the Internet to seek information are mostly coordinators, and they’re primarily using Google or other general search engines instead of seeking more targeted information such as websites of trade groups including the Association of Clinical Research Professionals (ACRP) and the Society of Clinical Research Associates (SOCRA).
“I thought people would report spending a lot of time on the ACRP and SOCRA sites,” said Levine.
Almost 80% of nurses (mostly coordinators) and 60% of doctors surveyed reported using Google. About 50% of nurses and less than 40% of doctors said they used the National Institutes of Health site. Next, in terms of usage, was the ACRP site, followed by SOCRA, then CenterWatch.
Awareness was very low, too. Only a small percentage of respondents had heard of bioethics-research institutions such as the Hastings Center or news outlets such as Medpage Today, added Levine, which surprised him.
Among the findings Levine expected were that 60% of respondents reported increasing difficulty in managing trial profitability, and 40% said they were seeing increasing difficulty in recruiting and retaining subjects. Specifically, respondents pointed to many more protocol amendments that require re-consenting; the amount of data from multiple vendors (diary, ECG, IVRS, remote data capture, CROs); protracted queries/resolution; and more detailed informed consents.
Eighty percent of nurses said they wanted more quality assurance training, while 60% of all respondents said they desired more training in preparing for FDA audits. This, said Levine, reflects a recent trend among smaller sites to put in place the same standard operating procedures (SOPs) as their larger brethren.
“The small and medium-sized sites have been feeling the pressure to have SOPs,” said Levine. “I wouldn’t think you’d need SOPs unless you had 10 to 15 coordinators. But now SOPs and a greater emphasis on quality are becoming expected.”