Some private-practice physicians who decide to conduct clinical trials can have trouble meeting enrollment goals because they forget to speak with their patients about study participation. Others inadvertently miss a patient visit and have to fill out numerous forms explaining why they deviated from the clinical trial protocol.
These are just two of the common mistakes made by investigators and sites when they undertake clinical research, said Kimberly Irvine, executive vice president of operations and regulatory at the Biomedical Research Alliance of New York (BRANY), an alliance of more than 200 clinical trial research sites.
According to Irvine, private-practice physicians often get involved in trials without a clear picture of the work required by them and their staffs. As a result, study sites can quickly become overburdened with paperwork. Staffs can become overworked and disenchanted. As a result, many first-time investigators refuse to take on a second clinical trial because their experiences were not what they had expected.
During her 12 years in the healthcare finance and clinical research industries, Irvine has observed these common errors, and determined how they can be avoided. Here are some of her suggestions:
Utilize experienced research staff. Irvine said it’s a common mistake for new, office-based investigators to have their existing clinical staff “wear a second hat” as research staff. Clinical research requires maintaining compliance with GCP, ICH, FDA and sponsor guidelines; when staff members lack training or experience, it can result in protocol deviations that necessitate submission of additional paperwork to explain the mistakes, creating a vicious cycle of paperwork and stress. “Sometimes an investigator will ask the office nurse, who has never been involved in research, to run a clinical trial. The nurse has never heard of an IRB submission, case report form or adverse event (AE),” said Irvine. “We’ve seen sites let AEs pile up because they don’t know what to do with them. Then when the CRA comes, there is suddenly an influx of 100 safety reports. This inevitably results in a trial that is poorly managed and an office staff resentful of the time and effort required to run the study appropriately.”
Set aside sufficient time for the study. Investigators often underestimate the amount of time needed to conduct a clinical study. Although the demands will depend on the protocol, all clinical studies require the principal investigator to understand the protocol, meet with the sponsor regularly, participate in the informed consent process, review documents, provide medical oversight, evaluate adverse events and take ultimate responsibility for the conduct of the study.
P.I.s need to recruit. Principal investigators can’t expect to delegate all clinical trial responsibilities to the study coordinator. The investigator, during routine appointments, has the opportunity to recruit patients into the trial. If the investigator is unwilling to raise the subject of research with patients, Irvine said the study will not meet its enrollment goals. “Not everything is the coordinator’s responsibility,” she said.
Ensure that the proposed clinical trial budget is adequate to cover study-related costs prior to committing to a sponsor. Investigators can easily determine the cost for procedures, but Irvine said they often forget to figure in the operational costs, such as the administrative time and study start-up. “If the investigator meeting is on a Friday, and the physician has clinic/office hours on a Friday, is he willing to give up those hours for a clinical trial? Sometimes he can get some type of reimbursement from the sponsor, but I’ve yet to see a sponsor pay for a whole clinical day,” said Irvine.
Anticipate advertising costs for patient recruitment. Many investigators don’t realize they are expected to find patients on their own. “This is an area where sites underestimate what they might need to help them accrue patients. Sometimes the sponsor will offer $1,000 for advertising, which won’t get you very far. But the sites either accept it because they don’t have enough experience to know what to ask for, or they think they can print flyers and that will be adequate,” Irvine said.
Don’t overpromise on study performance. New investigators often over-estimate the number of patients they can enroll in a study or don’t understand all the demands of running a clinical trial, including the regulatory requirements. They frequently overpromise on what they can deliver. “Sometimes they don’t really understand their role sufficiently,” Irvine said. “When investigators get a study, it’s very important for them to perform as promised and to be honest in their assessment of their ability to recruit patients and run the study smoothly. It’s much better to under-promise and over-deliver than the converse. Sponsors need to have a realistic view of what they are going to get from the sites.”