The spirit of sharing and caring is visible in the clinical trial industry, where numerous service providers and other professionals are stepping up by donating valuable time and insights to help battle the deadly COVID-19 pandemic.
“ACRP members and others who conduct clinical trials are on the front lines in this life and death battle,” says ACRP Executive Director Jim Kremidas. “Even in this most challenging of times, it is heartening to see how the clinical trial industry is rallying, united in purpose to save lives and mitigate the spread of this global pandemic.”
For example, Advarra is currently allowing research staff to get timely answers to their important regulatory questions at no charge. Launched March 16, their Ask Advarra resource fielded more than a hundred inquiries in its first three days. Staffed by a team of regulatory experts, Advarra promises responses in a single business day, though it’s actually been getting responses to most people within a few hours, says Advarra Chief Commercial Officer Robann Cunningham.
“We’re all in this together,” says Michele Russell-Einhorn, JD, Chief Compliance Officer and Institutional Official at Advarra. “A silver lining in this crisis is it has shown the importance of clinical research,” she adds. Advarra has also pulled together a summary of many of the questions and answers at https://www.advarra.com/coronavirus-guidance/.
Common questions from users in the field include how to handle changing study procedures, challenging informed consent issues, and transitioning drug distribution from a hospital or clinic setting to home delivery, Russell-Einhorn says.
In addition, Advarra has reviewed the majority of coronavirus and COVID-19 protocols for government agencies, pharmaceutical firms, contract research organizations (CROs), and institutions in the U.S. and is offering priority review for these studies, for which it will also waive the protocol review fees, Cunningham says.
In addition, CEO Sharib Khan and the team at TrialX have unveiled https://covidclinicaltrials.com/, which features a real-time listing of clinical trials related to COVID-19. “This is the time for clinical trials” to help battle the pandemic, says Khan.
Elsewhere, Veeva Systems announced on April 2 the availability of new remote monitoring capabilities in Veeva SiteVault Free for source document review and verification in clinical trials. Veeva SiteVault Free gives research sites a free eRegulatory application to efficiently manage study documentation while enabling study monitors to access, review, and collaborate on content online. Sites can centralize monitoring and communication with sponsors and CROs using the system, which is compliant with 21 CFR Part 11 in the Code of Federal Regulations and Health Insurance Portability and Accountability Act (HIPAA) requirements.
“I’m optimistic about the future of clinical research,” Cunningham says, noting pressures from COVID-19 may “catapult” the clinical research industry into making leaps forward in technology, best practices, and a number of other areas. “Traditionally, the clinical trial industry has been slow to change,” she notes.
“It’s my hope we implement some of these changes permanently” after the COVID-19 crisis abates, Russell-Einhorn says. “I think we’ll see some of the bias against remote visits, telemedicine, and the like diminish” after they’ve proven their worth during the crisis, she adds.
Author: Michael Causey