June 25, 2018
Clinical trials for psoriasis drugs fail to reflect their real-world safety and efficacy, according to the findings from an observational study by a team of U.K. researchers reported in JAMA Dermatology. The researchers studied what proportion of patients with psoriasis who were taking a biologic and were on the British Association of Dermatologists Biologics Intervention Register (BADBIR) would have been eligible for the pivotal licensing trials of biologics for psoriasis. In their study of 7136 patients, those identified as ineligible for clinical trials had lower effectiveness and higher rates of serious adverse events while receiving biologic therapy in the first 12 months compared with patients identified as eligible. The findings aligned with a 2012 study that found a disparity between real-world data and clinical trials for dermatological drugs. The new study suggests that clinical trial protocols and the reasoning behind them need more transparency, according to the authors who say sponsors should consider alternative prelicensing study designs or postmarket studies set at the time of licensing. Read the full article here: https://jamanetwork.com/journals/jamadermatology/article-abstract/2674865.
Alzheimer’s Researchers Must Mind the (Gender) Gap
Alzheimer’s researchers should pay closer attention to the different ways the disease affects men and woman, a new paper argues. There are a host of gender-specific risk factors for women and dementia, from hypertensive pregnancy disorders to gynecological surgeries but there’s a dearth of work on how these different factors might create different treatment options for men and women, wrote corresponding author Rebecca A. Nebel of the Society for Women’s Health Research. “The exclusion of sex and gender has impeded faster advancement in the detection, treatment and care of AD across the clinical spectrum,” Nebel and her colleagues concluded. Their findings were published in the latest edition of Alzheimer’s & Dementia, a journal of the Alzheimer’s Association. You can read the full study here: https://www.fdanews.com/06-15-18-Alzheimer.pdf.
Outcomes Research Group Publishes Guidance on Use of Wearable Devices in Clinical Trials
The International Society for Pharmacoeconomics and Outcomes Research released new guidance on the use of wearable medical devices in regulatory clinical trials in the latest issue of its Value in Health journal. When assessing a device’s appropriateness for use in a trial, sponsors should consider the device’s safety, suitability for trial objectives and the patient population and the evidence that it provides the required level of measurement accuracy and precision, the consortium recommends. “Wearable technology enables us to gather more information about treatment effects during our clinical development programs, and this provides greater insights and important evidence supporting the findings of other study endpoints. It also enables us to collect data that are perhaps more relevant to the patient, for example, free-living activity compared with in-clinic functional performance tests. As we develop more patient-centric trials, these kinds of measures may enable us to get closer to the measurement of the things that really matter to the patient, in addition to facilitating more remotely conducted studies.” “Although there remains a lack of specific guidance from regulatory bodies on the use of wearables in clinical trial programs, we believe this work provides a robust framework for the adoption of wearables in regulatory trials,” said lead author Bill Byrom of the UK’s ICON Clinical Research. Read the full report here: https://www.valueinhealthjournal.com/article/S1098-3015(17)33532-5/fulltext.
New Studies Provide Data on How Professionals Can Improve Clinical Trials
The Tufts Center for SDD and Veeva Systems announced the availability of a new report on the root causes that slow clinical trial timelines. Tufts conducted dozens of one-on-one interviews with industry leaders and concluded that protocol design changes, data management delays and technology incompatibility are among the greatest contributors to longer clinical trials. Tuft’s Ken Getz and Veeva’s Richard Young will present full findings at the DIA Annual Meeting this week.In addition, Veeva announced that it has completed its annual Unified Clinical Operations Survey. The survey finds that the nearly 9 in 10 respondents, or 87 percent, claim to be moving to a unified clinical operations landscape for better visibility and improved clinical trial execution. Since the inaugural clinical operations survey was released three years ago, life sciences companies have been increasingly replacing manual processes and paper with e-clinical technologies, according to Veeva. But there are still significant gaps — 100% of respondents report their clinical trial management systems (CTMS) are not optimal. Now, survey results point to a new shift where companies are trying to bring together all of their systems and processes to improve reporting, collaboration, and efficiency. The full results also will be presented at DIA’s Annual Meeting. More information is available at http://www.veeva.com/clinicalsurvey.