The Henry Ford Cancer Institute has initiated the first-ever adaptive trial platform for brain cancer, focusing on glioblastoma.
The study, called GBM Agile, combines phase 2 and 3 trials testing multiple therapies against a common control or standard of care. The long-term study will employ an adaptive randomization technique, using data collected throughout the trials to continually refine subsets of patients likely to benefit from a particular therapy.
The adaptive trial is designed and sponsored by the Global Coalition for Adaptive Research, an international collaboration of glioblastoma clinicians and trial design experts.
Trials using ClinOne’s trial management platform can take advantage of a new patient media package designed to increase engagement.
The media package, available to trials using the ClinTrialConnect platform, includes a thank you note from trial doctors, a newsletter focused on the participants’ studies, press releases about the organizations’ activities, scientific publications, as well as patient caregiver stories and information about community events.
ClinOne will distribute the packages bi-monthly, quarterly or bi-ennially. ClinOne also will report back to the research organization on patients’ engagement rate with the platform.
The number of U.S. cancer trials reporting results by specific racial and ethnic groups has increased less than 1 percent in the past 10 years, a new study shows.
Of 230 oncology drug trials that led to FDA approval between 2008 and 2018, only 7.8 percent of them documented results among all four major races in the U.S. – black, Hispanic, Asian and white – according to a study from researchers at the MD Anderson Cancer Center, Fred Hutchison Cancer Center, Baylor University and BC Cancer in Canada.
Almost 63 percent of the trials reported on white participants, 47.8 percent reported on Asian subjects, 38.2 percent on black participants and only 10 percent on Hispanics.
Safety reporting is a key element in South Korea’s new five-year clinical trials management plan.
Broad goals of the plan, which covers 2019 to 2023, are to establish a clinical trial safety management system and expand patient recruitment opportunities and communication systems.
Guidelines accompanying the plan call for reporting safety information to the government, especially key safety information such as unforeseeable side effects.
South Korea’s Ministry of Food and Drug Safety also is calling for the creation of a central IRB as well as creating a center to help educate trial participants. The ministry also proposes creation of a central clinical trial review committee to consult medical institutions and plans to test a new clinical trial approval system next year.
A new laboratory information management system (LIMS) from Almac Diagnostic Services is designed to keep track of clinical trial samples and reduce errors in sample management.
The sample management solution provides pathology review, digital pathology, sample receipt and storage and downstream processing, to ensure that samples make it from point of collection to their destination. Its barcode system enables a trial to locate samples at any time or place.
Almac’s LIMS, working in partnership with a global logistics specialist, standardizes documentation to ensure that samples are labeled correctly per manifest and are identifiable when sent by the clinical trial sites or vendors.
A longitudinal study of a rare form of Alzheimer’s Disease will collect real-time data from participants using their own mobile devices.
Datacubed Health’s Linkt platform will capture data on sleep, diet and other biomarkers from trial participants with Dominantly Inherited Alzheimer’s Disease (DIAD).
The study, conducted at the Washington University School of Medicine in St. Louis, will include an observational study, clinical drug trials and a research registry.
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