Weekly Features

Clinical research in the cloud, with help from Microsoft

Monday, October 30, 2017

Clinical research technology is expanding, and there is now infrastructure to back it. Last week, Parexel, a global clinical research organization, announced a new partnership with Microsoft to develop innovative cloud-based services for their clients. The collaboration will bring Parexel’s current tech offerings to the Microsoft Azure cloud platform and catalyze new developments aimed at enhancing participant engagement in clinical trials, and streamlining drug development.

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Partnership aims to accelerate development of new immunotherapy strategies

Monday, October 23, 2017

The Partnership for Accelerating Cancer Therapies (PACT) has launched thanks to a partnership between the NIH and 11 biopharmaceutical companies. The goal of the new partnership is to accelerate the development of new cancer immunotherapy strategies for more patients in half the time. The initiative specifically aims to explore the question: Why doesn’t immunotherapy work for all cancers, in all patients, and what can be done about it?

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Investigator attrition and solving the “one and done” phenomenon

Monday, October 23, 2017

A significant number of trial investigators are abandoning the field of clinical research, sometimes after only a single study. When the Clinical Trials Transformative Initiative (CTTI) noted this high investigator turnover, they decided to issue guidance on how to tackle the issue. Established by the FDA and Duke University, CTTI is an organization dedicated to improving the clinical trial industry—the trials themselves, the safety of participants and the obligation to stakeholders. Their focus is on clinical trials performed for regulatory submission.

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Vivli announces new data sharing platform for clinical trials research

Tuesday, October 10, 2017

The Laura and John Arnold Foundation has recently donated $2 million in funds to Vivli, a Massachusetts nonprofit, for establishing a unique data sharing platform for use in clinical trials.
“This financial support allows us to quickly move to launch the platform in 2018,” said Dr. Ida Sim, Vivli co-founder and technical lead. “Vivli’s technology and coordinated policies and processes will lead to new scientific discoveries from integrating existing datasets.”

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Changes needed for EDC to show true efficiency

Monday, October 2, 2017

Three quarters of clinical trial managers report challenges loading data into their EDC systems, which in turn increases the time it takes to build study databases and then delays trials.
Eighty-three percent of life sciences organizations release a clinical database after the first patient, first visit. It takes an average of 68 days to build and release a clinical study database, which contributes to an increase of nearly a month downstream in the completion of a trial.

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Cybersecurity: Lessons learned in a hacker’s era

Monday, October 2, 2017

Cybersecurity is back in the public eye, with multiple incidents of malware attacks across the globe. Merck recently suffered an attack that disrupted the company’s manufacturing capabilities. Citing concerns about the drug supply, the U.S. House Committee on Energy and Commerce has asked Merck for an update by this week. The potential for cybersecurity intrusions also touches the medical device industry. Most recently, the U.S. Department of Homeland Security and ICS-CERT issued an advisory identifying eight cyber security vulnerabilities in an infusion pump from Smiths Medical. Previously, the FDA issued safety communications regarding vulnerabilities found in certain St. Jude Medical/Abbott cardiac pacemakers and Hospira infusion pumps.

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