Clinical News Roundup for the week of September 19, 2016 with stories on HHS and ClinicalTrials.gov, FDA approval of Exondys51, DCRI coordinating National Study of Childhood Health, and the world's largest breath-based clinical trial.
The healthcare industry’s transition to value-based care is putting a lot of pressure on pharmaceutical companies in terms of margins and the need to demonstrate improved outcomes at lower costs. In attempting to create breakthrough therapies and “beyond the pill” solutions with fewer resources, companies are demonstrating an increased appetite for outsourcing functions – and Contract Research Organizations (CROs) could be the beneficiaries.
Data managers are critical to the clinical research process. It’s the data they collect which will ultimately determine whether a new drug gains FDA approval. Recognizing that, the Society for Clinical Data Management (SCDM) was established to work with the teams creating clinical trials, writing the protocols, and identifying the information that needs to be captured. Over the years, the information gathered by SCDM members has been incorporated into a guide book of Good Clinical Data Management Practices, which SCDM is now making available to nonmembers as well as association members.
Mobile and wearable technologies are making their way into clinical trials, helping to produce better data and engage patients in their health and treatments. But incorporating these devices also presents additional risks. What can companies do to overcome barriers and incorporate these devices into clinical trial protocols? In this Q&A article, Dmitri Talantov, M.D., R&D Operations Innovation Medical Leader, Janssen Research & Development, LLC shares his insights.
Clinical news roundup for the week of August 29, 2016 with articles on clinical trials for dengue vaccine, Dr. Reddy’s patient-centric platform, patient recruiting via tablet apps, Leapcure and Scientist.com partnership, Validic joining forces with SAP, and heart disease drugs in clinical trials.
Clinical news roundup for the week of August 22, 2016 with information on the Bioclinica acquisition by Cinven, SCRS Eagle Award finalists, supporting kids with brain tumors, reducing risk in adaptive trials, Zika testing in humans, and more.
Clinical news roundup for the week of August 8, 2016 with articles on using pets in clinical trials, the Quintiles/DaVita alliance, the benefits and pitfalls of data sharing, and the Orphan Drug Act.
Is risk-based monitoring (RBM) changing the role of monitors in clinical trials? In the latest issue of the Pharmaceutical Outsourcing Monitor, Michael Martorelli of Fairmount Partners takes a look at this issue, and features some interesting feedback from readers along with informative insights from Jim Kremidas of ACRP and Clara Heering of ICON. How is RBM changing the role of monitors and what do you need to know?
It’s a problem that clinical researchers have dealt with for years. A researcher has an idea for a study. They identify an existing data set, produced by other researchers, which would be ideal for that particular study. Although that data is not currently being used, the researcher is not able to access and use the clinical trial data because it is not being shared. This is a situation that Johnson & Johnson (J&J) is hoping to change.
Clinical trial operations is fraught with many hurdles, including quality, cost, and timeliness. To successfully bring new medicines to market, operations managers have to successfully overcome these challenges. Application software provider Comprehend recently produced a “Clinical Operations Benchmark Report,” in which it surveyed executives at leading life science companies. The goal was to determine how companies can speed up trials and more quickly get to quality results across a portfolio of products.
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