August 19, 2019
The FDA has named five acceptable endpoints for trials of gastroparesis treatments in a draft guidance released last week.
The agency says that five core signs and symptoms of the disease that prevents proper emptying of the stomach should be used as primary endpoints: nausea, vomiting, fullness after a meal, early satiety and abdominal pain.
Sponsors should provide a primary endpoint definition and a method for measuring each of the five signs and symptoms described in the guidance. For example, the agency recommends that all signs be given a rating of severity, except for vomiting, which should be measured in terms of the number of times it occurs over a 24-hour period.
The trial’s primary efficacy assessment should be based on changes in patient-reported signs and symptom scores.
The stomach’s emptying time should not be used as a primary efficacy endpoint, the agency advises, “because changes in gastric emptying time are not associated with the changes in the clinically important signs and symptoms” of the disease; however, it may be used as a secondary endpoint.
The comment period closes September 21.
Read the draft guidance here: https://bit.ly/2TxnXjt.
VirTrial Launches Training and Certification Program
Telehealth platform provider VirTrial has launched a program to train research sites to conduct hybrid in-person clinical trials.
The platform — which offers video, text and email messaging — helps sites coordinate and conduct virtual visits as well as manage communication among trial subjects, investigators and trial staff. Research sites that complete VirTrial’s training will receive certification and be placed on a list of “Virtual Trial Capable” sites that the company will share with sponsors and CROs.
IQVIA Patient Portal Provides Real-World Trial Results
IQVIA’s new patient portal will give trial participants a window into the clinical research process by giving them access to their lab results and other study-related information.
Participants in trials that use the Patient Portal are offered access when they are recruited. Throughout the trial, they receive visit and medication reminders, disease education and travel support services.
The Patient Portal is part of IQVIA’s suite of trial support tools but also can be used as a stand-alone solution.
FDA Collaboration Pulls RWE in Clinical Oncology Trials
Syapse and the FDA’s Oncology Center for Excellence are collaborating on ways to better use real-world evidence (RWE) to support the agency’s regulatory process.
The collaboration will focus on regulatory questions about testing and treatment patterns, dosing and safety, and outcomes, and will investigate multiple sources of RWE in addition to electronic health records and registries.
Syapse’s oncology researchers from its Learning Health Network will participate in the effort.
Saama Builds on Cloud-Based AI with Comprehend Acquisition
Data analytics company Saama Technologies has purchased cloud-based AI company Comprehend Systems to support its clinical analytics platform.
Saama has been using an AI-driven clinical data analytics platform to draw clinical insights from real-world evidence. By adding Comprehend’s Clinical Intelligence Platform, Saama will increase its support of CROs. Under Saama, Comprehend will partner with Rockville, Maryland-based CRO DP Clinical to deploy its centralized trial monitoring software tool.
Signant Program Supports CRO-Sponsor Communication
Signant Health’s new partner program teams with CROs to help them improve communication with and service to sponsors on all aspects of clinical trial management.
The program will provide support on protocol design and optimization, data quality oversight, patient engagement, eConsent and clinical supply management. Signant also will offer its partners exclusive commercial terms, business development support, joint marketing, clinical and scientific expertise, product training and dedicated resources for governance.
Boehringer-Ingelheim Forms Virtual Research Center with MD Anderson
Boehringer-Ingelheim has partnered with the University of Texas MD Anderson Cancer Center to conduct research on therapies for a variety of cancers.
Through the virtual research center, BI and Anderson will share data and analysis on studies of products in the pharma giant’s pipeline from the research stage through clinical trials. The center will be staffed by investigators from both partners.
The partnership will focus on investigation of BI’s lung and gastrointestinal cancer candidates.