The Clinical Trials Transformation Initiative is developing several new sets of recommendations relating to clinical trials — on the qualification of investigators, the potential legal and regulatory hurdles to decentralized trials and obstacles to incorporating mobile technology, according to its 2017 annual report. In the report marking the organizations 10th anniversary, CTTI also aims to develop toolkits personalized to stakeholders to help with adoption of its recommendations and says it will share case studies with the clinical research community to show how the resources can be applied to improve processes and outcomes. The initiative issued five new sets of recommendations last year including: developing novel endpoints generated by mobile technology; making registries into reusable platforms for conducting clinical trials; providing for pregnancy testing in clinical trials; strengthening pediatric trials in antibacterial drug development; and strengthening the investigator site community. Read the CTTI annual report here.
Women are underrepresented in clinical trials for heart diseases when considering their prevalence within each disease population, according to study findings reported in the Journal of the American College of Cardiology. To determine the percentage of women enrolled, researchers looked at 36 approvals for 35 drugs for diseases such as acute coronary syndrome/myocardial infarction, coronary artery disease, heart failure, atrial fibrillation and hypertension, to determine the percentage of women enrolled. Researchers found that just 34 percent were women. The researchers concluded that factors prior to screening, such as the ability of a candidate to participate and the identification of potential trial participants, may be the reasons behind the low number of women, as the data in this latest study shows that the low number of enrolled women reflects the lower number of women referred for pre-trial participation screening.
A study published in The Oncologist found that patients who enroll in clinical trials for treatment experience a heavy travel burden. The study analyzed the data of 1,600 patients who enrolled in clinical trials between 1993 and 2014, measuring the distance they traveled from their home to the site of the study and finding that, overall, patients traveled a median distance of 25.8 miles. Patients in NIH-sponsored studies had to go even greater distances, incurring 39.4 miles on average, and patients in phase 1 studies had to travel farther than any other type, navigating a median of 41.2 miles to participate in them, the study said.
Academic institutions have been slow to get on track with stricter requirements released by the HHS and NIH for clinical trial registration and reporting, according to a study by the Johns Hopkins Bloomberg School of Public Health. The study, published May 2 in the BMC Medicine journal, looked at survey data from over 350 U.S. academic institutions that conduct clinical trials. The researchers found that relatively few had enough staff or necessary policies in place to comply with the new requirements. Before the stricter requirements came into effect, the researchers conducted an online survey of academic institutions registered on ClinicalTrials.gov to determine how prepared they were for the new requirements. Of the 783 eligible accounts contacted, they received responses from 366. Only 43 percent of the accounts had a policy for clinical trial registration, and only 35 percent had a policy on reporting trial results. Survey respondents frequently reported devoting almost no staff time to the website’s registration and reporting requirements, with a median full-time staff equivalent of 0.08, or just a few hours per week devoted to regulatory compliance.
Online clinical trial data resource Clinical Study Data Request (CSDR) has launched data-sharing collaborations with four nonprofits to expand the services it offers to researchers. CDSR will partner with the Wellcome Trust, the Medical Research Council, Cancer Research UK and the Bill & Melinda Gates Foundation. The groups will help CSDR broaden its offerings to include academic-led clinical trial data on top of the patient-level clinical data it already offers.