In some ways, these are the good old days for clinical research because the industry is supplying hope, fostering economic well-being, and saving lives during a “stressful” time in history, Steven Beales, senior vice president for Scientific and Regulatory at WCG Clinical, told attendees of the ACRP 2020 Virtual Conference yesterday (June 11).
Other speakers focused on such hot-button topics as recruitment, risk management, and audits for clinical trials.
Risk often originates in poorly designed protocols, said Walaaeldin Ahmed, managing director for the KAUMED clinical research organization. Ahmed also spelled out several other potential sources of risk in clinical trials, including:
- Insufficient planning for issues associated with the study population and investigational product
- Inadequate planning for trial conduct
- Poorly chosen sites and/or investigators
- Inexperienced site personnel
- Lack of adequate sponsor oversight, especially in the realms of monitoring and safety
Turning to recruitment, the team at Uptown Research Institute (URI) emphasized the importance of being selective and realistic at the very outset. “You have to choose a study you will be good at, with [adequate] support such as childcare if needed,” said Gwen Jacobs, a senior clinical research nurse at URI.
It’s also vital to connect with prospective and current patients, Jacobs said. “Make them feel like a partner in their own care” rather than lecturing or droning on and on with a verbal torrent of data and instructions, she said.
While the results of recruitment efforts through kiosks at community fairs were mixed, URI President John Sonnenberg said even if he wasn’t convinced they garnered any patients directly, participating at such events still had value because it raised overall awareness of clinical research.
Molly Pease, URI recruitment manager, touted targeted open houses at study sites to highlight specific trials. Provide potential patients with lunch, and you can also show them the in-patient unit where they’d be participating in the trial, she said. The tactic has proven effective in attracting and retaining new recruits, she added.
The URI team offered several other “do’s” of retention, including:
- Educate subjects with regard to common medical issues such as blood pressure and diabetes.
- Provide patient reminder calls the day prior to the schedule visit.
- Ensure the principal investigator does the subject selection for every study; all subjects should know they can go to the investigator if they have any issues.
- Provide transportation through an independent company for patients requesting it.
- Provide snacks and lunch, as needed.
- Offer an automated payment system that provides immediate payment.
- Provide masks in time of COVID-19.
- Provide essential supplies to patients in need, such as socks, toothbrushes, and winter hats.
The ACRP 2020 Virtual Conference concludes June 25 with sessions focusing on workforce development.
Author: Michael Causey