May 29, 2018
Elligo Health Research announced Thursday that it was buying ePatientFinder’s technology platform, a move that Elligo officials said will “streamline patient identification and feasibility through automation using electronic health record data.” ePatientFinder has claimed its Clinical Trial Exchange was the “first and only” technology platform that linked up doctors, clinicians, sponsors and EHR providers. The platform is the largest of its kind and Elligo sees is acquisition as “a strategic opportunity … to expand our technology and network growth capabilities,” the company said in a news release. The deal comes just two months after Elligo announced that it had raised $16 million from venture capitalists to continue its goals of reaching the 97 percent of physicians who don’t regularly participate in clinical trials. Terms of the deal were not disclosed.
CRAs ‘Consistently Underperforming,’ Consulting Firm Claims
CRAs are “consistently underperforming” in tests measuring their attention to site compliance, data integrity and quality, a consulting firm claims to have found in a new study. Researchers at CRA Assessments LLC ran some 579 CRAs around the world through a web-based site simulation to test their monitoring skills. Regardless of the CRAs’ experience levels, average proficiency scores ranged from the low-to-mid fifties to the mid-to-high seventies, the researchers found. The overall average for all the surveyed CRAs was 60 percent. CRAs scored the worst when asked to look out for potential fraud (a median score of 33 percent), but also scored low in IRB reporting (58 percent), IRB submission (50 percent percent), source documentation (67 percent) and source to electronic data capture domains (60 percent), CRA Assessments reported. “The analysis reveals first and foremost that CRA average competency scores were near equivalent regardless of CRA title,” the study said.
European Consortium Launches Six-year, $165M Project to Streamline Pediatric Trials
European drug companies and academic researchers announced a new, six-year, $165 million project that organizers hope will coordinate clinical trials for pediatric medicine across 20 countries. The conect4children initiative will be coordinated and led by staff at Fondazione PENTA and funded by EU Innovative Medicines Initiative grants and in-kind contributions from private drug companies. Its goal is to streamline clinical trials for children by creating “a single point of contact for all sponsors, sites and investigators,” making trials more efficient by adopting consistent approaches, standards and coordination, and to improve coordination and conversation among experts across disciplines, the group said in a news release issued last Monday.
FDA Publishes Draft Guidance on Maximal Usage Trials for Active Ingredients Being Considered for Use in OTC Monographs
The FDA issued its recommendations for designing and running a maximal usage trial (MUsT) for topical active ingredients that are being considered in an over-the-counter monograph. The MUsT’s study population should represent the population expected to use the product and, if the product has more than one indication with different populations, it should select the population that has the highest potential for dermal absorption. Sponsors should consider factors such as skin surface area to be exposed, dosing frequency if different for different indications and factors that affect skin permeability, such as a tinea pedis. Determining the sample size for the MUsT should involve considerations of the study design and any potential sources of inter and intrasubject variability. If the information needed to determine the sample size is unavailable — such as the expected inter -and intra-subject variability — the agency recommends the sponsors conduct a pilot study using the formulation with the highest potential for permeation based on in vitro testing.
WCG Announces Opening of New Office in Japan
WCG Clinical announced Wednesday that it is opening an office in Japan. The new office is part of an effort to expand the company’s Asia/Pacific footprint in the hopes that it “will strengthen its ability to support increasingly complex, global clinical trials, particularly in the critical areas of drug and diagnostic development for oncology and central nervous system diseases,” WCG said in a news release. WCG already operates in 65 countries around the world and Asia offers “research sponsors … access to a large number of patients for clinical trial recruitment,” the company said.
WCG Foundation Rebrands as Clinical Research Pathways
The WCG Foundation is rebranding as Clinical Research Pathways, the group said in a news release Wednesday. The new name “better reflects the public charity’s emphasis on expanding patient and physician access to investigational drugs and promoting inclusion in clinical research,” the group said. The nonprofit group, based in Atlanta, was founded by WCG, parent company of CenterWatch. It’s designed to help doctors and IRBs streamline the FDA’s clinical trials approval process.