Clinical Operations Featured Articles

81. How RBM Is Changing The Role Of Monitors 8/11/2016

    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?

82. J&J Takes The Lead In Clinical Data Transparency 8/10/2016

    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.

83. Survey: Do Spreadsheets Still Hamper Clinical Trial Speed & Quality? 8/8/2016

    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.

84. Will Liquid Biopsies Transform Oncology Clinical Trials? 7/29/2016

    Epic Sciences says it has developed a technology that CEO Murali Prahalad believes will transform oncology trials by identifying and characterizing circulating tumor cells. Those cells have been long recognized as a key part of cancer metastasis. Tumors shed these cells into the circulatory system where they then travel to different parts of the body and, under the right conditions, become the genesis of new tumors.

85. Can We Make Clinical Research More Useful? 7/28/2016

    Of the approximately one million papers on clinical research published to date, most are not useful. “Waste across medical research has been estimated as consuming 85 percent of the billions spent each year,” says John Ioannidis in an article titled, “Why Most Clinical Research Is Not Useful.” He points out that most published research is false and more of it needs to be made true. If true, what can we all do to make it better?

86. 3 Patient-Centric Steps to Increase Retention 7/26/2016

    Patient centricity is a growing trend in our industry. From the creation of Chief Patient Officer positions to culture-change initiatives, one of the strategies to improve the quality of clinical trials is to treat patients as “consumers” rather than “subjects” in a study.

87. Why The Explosive Growth In Post-Approval Research? 7/26/2016

    Post-approval research, also known as Phase 4 trials, is a segment of the clinical space that is growing very fast. Research shows that 13.7 percent of total R&D expenditure by pharmaceutical and biotechnology firms in 2014 was spent on conducting post-approval studies. In fact, post-approval research has been growing faster than any other area of clinical research.

88. The Changing Role Of CROs 7/25/2016

    Sponsors can have wide-ranging relationships with their CROs, from strategic partnering arrangements all the way down to the more simplistic transactional models. Regardless of the model in place, how do sponsors actually view the role of CROs in clinical development? A recent survey by Worldwide Clinical Trials attempted to answer that question.

89. Combining PROs And Clinical Data To Benefit Cancer Patients & Researchers 7/21/2016

    Earlier this year PatientsLikeMe had the opportunity to collaborate with M2Gen in a real-world oncology study that combined clinical, molecular, and patient-reported data. This would help researchers develop more targeted treatments and help cancer patients better navigate treatment decisions. 

90. Are Your Clinical Trials Prepared For The Coming mHealth Tsunami? 7/18/2016

    Excitement around mHealth technologies has been building for years. While initial apprehension kept many companies from jumping into the space, sensors are finally starting to make it onto patients. In this Q&A, Glen de Vries, president of Medidata Solutions, discusses progress the industry has made, concerns that remain, and what the future holds for mobile and wearable technologies.