Clinical Researcher—January 2021 (Volume 35, Issue 1)

OVER THE TRANSOM

Gary W. Cramer

Nothing stays still for very long in the world of technology and best practices for clinical trials, and the companies rolling out their new goods and services aren’t shy about broadcasting what’s brand new, what’s been retooled, and what’s on the horizon for research sponsors and sites to consider adding to their arsenals. The sites and sponsors themselves are often keen to be seen as applying cutting-edge tech and practices to their studies.

For your background information and possible use, in this beta test of a new column for occasional appearances in the pages of Clinical Researcher I will share tidbits about some of the latest such items and observations to come to my attention (no endorsements implied).

In Search of Streamlining

In a recent techXpo session for the Virtual ACRP 2020 conference (now available as a free webinar replay), representatives from Remarque and Premier Research focused on “dismantling the status quo of monitoring” by “moving toward a technology-enabled approach to trial oversight.”

For too long, the idea of monitoring has been mostly limited to clinical research associates (CRAs), onsite monitoring visits, and 100% source data verification (SDV), the presenters said, adding that this approach is time consuming, costly, and ineffective. They endorsed the concept of leveraging technology to approach monitoring using a holistic, data-driven, and risk-based data strategy plan. In their vision for the future of data monitoring, the process is streamlined in a single system used to assess site performance and overall trial oversight.

A lot of the assumption has been that 100% SDV equals better data quality, but it’s been shown that this is not the case, the techXpo session presenters contended. Limited interaction between sites and CRAs and lack of surveillance in between onsite monitoring visits present problems for reliable SDV; however, “there is an idea that if we are doing less than 100%, there will be some kind of fraud in the trial,” they noted. In reality, they cautioned, it is very hard to spot fraud when doing 100% SDV and looking at data on a “very micro level.”

“We are really beyond ready for a change” from this approach, the experts said. “A transition to a risk-based approach is really the next leap in the industry.” The shift should be to a bigger, macro, top-down view of the data, they added, in terms of which data to look at based on high or low risk in a study and focusing on critical datapoints versus all datapoints. The risk-based approach will incorporate all kinds of monitoring practices and roles, and will begin with a definition of quality up front (as in, quality by design), and with the percentages of source data review and SDV being defined from the beginning.

“We should be leveraging technology by consolidating all study data and monitoring tasks in the same system,” the presenters concluded.

The Other 95%

Inato says that the current way clinical research is conducted—with sponsors repeatedly tapping the same 5% of available research sites for conducting trials—doesn’t work anymore. It’s too slow and expensive, and patient diversity is nearly non-existent, the thinking goes. To raise the profile of the remaining 95% of qualified research sites, Inato has rolled out a new trials marketplace in which these sites can search for and get matched to trials that they are not only qualified for, but that also fulfill their interests and patient needs. Inato’s current areas of focus (in the U.S. and France) are multiple myeloma, lung cancer, and ulcerative colitis/Crohn’s disease.

Mastering the Trial Master File

According to news received last fall, the first independently accredited Trial Master File University (TMF University) intends to have launched its inaugural training series devoted to managing TMFs—compilations of all the necessary documents produced during the conduct of a trial that are key to inspection readiness—by this point in January 2021. Facilitated by LMK Clinical Research Consulting, TMF University is accredited through the International Accrediting Organization for Clinical Research (IAOCR).

“Individuals supporting the TMF play a significant part in the success of clinical trials,” said Jackie Morrill, PMP, executive director of clinical operations at LMK. To develop the curriculum, LMK dissected different job roles within the pharmaceutical and clinical research spaces and, with IAOCR’s input, tailored training options specifically to employees’ job descriptions and responsibilities.

Aiming Technology at the Pandemic

As BetterLife Pharma prepared last fall for clinical trials of AP-003, its interferon alpha 2b inhalation therapy for the treatment of COVID-19, it provided details on how it expected to leverage technology to overcome potential challenges of recruiting patients.

Noting that the trials have been designed to promote study participation and streamline data collection, BetterLife indicated that participants with mild to moderate COVID-19 would self-identify for potential trial enrollment following COVID-19 testing at testing centers. Trial consent is being obtained virtually and the trial is conducted via telemedicine from the participant’s home, with all data collection being accomplished electronically to allowing for rapid review.

‘’[W]e have made significant strides in advancing these trials in Australia,” BetterLife CEO Dr. Ahmad Doroudian said in October. “Using new and innovative technology will allow us to be in the vanguard of clinical study design, to easily meet our enrollment goals, and to expedite any potential [U.S. Food and Drug Administration] approval and commercialization of AP-003 for the treatment of COVID-19.”