Turning a Chapter in the Quest for Education and Networking

Long-time ACRP members are well aware of the many opportunities available for learning and networking through the Association’s annual meeting. For those who need to maintain their certifications, attending each year is an efficient method of gaining contact hours toward doing so. Sometimes however, circumstances of timing, location, and employer reimbursement for the meeting can stymie the best-laid plans for attendance.

What many members, both newbies and veterans, may not stop to consider are the opportunities for earning contact hours and expanding their professional networks by going to nearby ACRP Chapter events. Take, for instance, the Central Virginia Chapter’s 2018 Fall Symposium, held in Charlottesville last week on the campus of the University of Virginia (UVA). More than 70 attendees from Virginia, North Carolina, Maryland, and New Jersey took advantage of the chance to earn up to 7.5 contact hours by hearing six presentations on hot topics in clinical research by speakers from several of those states plus Florida, Georgia, and Pennsylvania.

The day started with an examination of competencies for members of the clinical trials team by ACRP Workforce Innovation Officer Beth Harper and Duke University School of Medicine Associate Dean for Clinical Research Denise Snyder, MS, RD, LDN. Snyder described how her institution has utilized the concept of core competencies in clinical research to update job descriptions (some of which had not been revised since the 1960s) with the goal of attracting and retaining a vital workforce.

Next up, Leslie Anne Hausser, PharmD, MPH, a regional senior medical science liaison for AstraZeneca’s Respiratory Medical Affairs unit, discussed several of the company’s initiatives, including its Open Innovation program for encouraging external researchers to revisit drugs that have failed in clinical trials for particular indications, but which might have uses in other situations. The program also may allow independent researchers to study certain “live” compounds for one indication while they are currently in AstraZeneca-sponsored trials for some other condition. It’s “a resource-efficient way to leverage existing tools and skills with public funding,” Hausser noted.

Former ACRP Association Board of Trustees Chair Robin Newman, MSN, CPNP, RAC, CCRA, worldwide vice president for clinical and medical strategic operations with Johnson & Johnson, took the stage to review new medical device regulations affecting researchers in the digital health arena (e.g., studying the software side of products tied to remote monitoring, virtual office visits, data mining, and site-based patient visits). Saying that the regulatory definitions for digital health products “are new [and] changing all the time,” Newman added that “these technologies really challenge our [traditional research] paradigm on many fronts…[and] reactive models are no longer sufficient.” She predicted that, because “benefit-risk” is a bigger concept in digital health than “risk-benefit,” more and more post-approval studies will be performed on these products over time.

A panel discussion on how changes to European Union (EU) privacy regulations embodied in the complexities of the new General Data Protection Regulation (GDPR) are impacting clinical research in the U.S. included the observation from panelist and UVA Associate University Counsel Beth Hodsdon that, if the Health Insurance Portability and Accountability Act (HIPAA) in the U.S. is “a cookbook, GDPR is a broad metaphysical treatise.” The regulation applies not only to EU businesses, but to companies internationally that offer goods and services to the EU and collect and process personal data on persons who are resident in the EU, thus adding a layer of complication to many multinational trials. Panelist Ellen Teplitzky, vice president for legal affairs with Premier Research, noted her company is “taking a cautious approach,” and had hired a data protection analyst to move Premier into compliance with GDPR. Meanwhile, UVA Director of Information Technology Policy and Compliance Tim Tolson opined that the GDPR “is no more clear on what security measures you should take” than it is about anything else. “We look at contracts as they come in, and if they already deal with HIPAA, they are probably good enough for GDPR,” Tolson said. “If not, they may need additional privacy protections added.”

Independent consultant Carol Bognar, RN, MSN, addressed timely issues of fraud and misconduct in the clinical trial industry, saying they have “an impact across the board…on how society views [clinical research and] on how products are evaluated.” Using real-world examples of fraudulent products, fabricated data, failure to conduct informed consent, dangerous treatment practices, incompetent institutional review board decisions, and more, Bognar highlighted the signs to look for if fraud at a study site is suspected.

Closing the day of learning, Andrew (AJ) Mills, executive director for Firecrest Strategy with ICON Clinical Research, tackled what he described as an unstoppable trend toward electronic informed consent (eConsent) becoming the standard practice in clinical trials. Saying that “eConsent can be better for patients, sites, and sponsors,” Mills predicted that everyone in the audience will be involved in a trial that has adopted eConsent within the next 12 months. Offering a roughly 30% increase in patients’ knowledge retention about the details of a study versus use of paper consent forms, eConsent may not be right for every study yet, but it “is here to stay,” Mills concluded.

To learn more about ACRP Chapter learning and networking events, visit the Events Calendar and look for the opportunities closest to where you work or will be in your business travels in the months ahead. Many chapters offer an educational session with contact hours at some or most of their regular meetings throughout the year, and you do not have to be an ACRP member to attend or earn contact hours. On November 12, the Circle City (Indianapolis) Chapter is the next to hold a symposium-style event similar to the Central Virginia Chapter’s event.

Author: Gary Cramer