Data Management Featured Articles

81. IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For September 2015 9/29/2015

    September was another very active month on Clinical Leader. In case you missed them, the top three articles for the month featured coverage of the ethical dilemma that can result from patient-funded trials, industry insights from Mike McKay, Associate Director of Operational Excellence for Shire Pharmaceuticals, and a look at research that seems to show the Sunshine Act might be having an unintended effect of reducing clinical research.  

82. WIB Profile: Embrace Change Management Or Expect To Fail 9/22/2015

    Risk management is a concern for all pharma companies, and the increasing rate of adoption of new approaches, such as risk-based monitoring, will keep it a concern for years to come. Of course with any new approach comes the resistance to change from employees and managers who don’t trust the new approach, feel it will make their jobs more difficult, or even worse, eliminate their jobs altogether.

    Change management can be one of the most difficult tasks for pharma executives to oversee. Consultant Angie Maurer’s job is to help them manage it more effectively. “It seems to take executives and personnel in the pharma industry a long time to accept, adapt, and deal with change within their organizations,” she says. “Everyone knows the pharma industry tends to be rather conservative, and that is as true today as it has always been.”   

83. How To Achieve Success In An FSP Relationship 9/14/2015

    Deciding to transfer responsibilities from one vendor to another in the middle of a study is something every clinical professional dreads. Laurie Callen, Director of Clinical Data Management at TESARO, an oncology-focused biopharmaceutical company, knows the feeling well. She recently had to do just that when her company sought to restructure its outsourcing model in clinical data management by entering into an FSP vendor alliance.

84. Clinical Insights: “RBM Is The Biggest Game Changer Since EDC” 9/4/2015

    Will risk-based monitoring be the hottest trend to hit clinical trials in years? Mike McKay, Associate Director of Operational Excellence for Shire Pharmaceuticals thinks it will be. “I believe RBM will be the biggest game changer to hit clinical operations since EDC (electronic data capture),” he says. It’s potential to increase quality and lower the time and cost of conducting clinical trials has only just begun to be explored. Think about it, why should we employ a traditional one size fits all monitoring approach when we know that there are good sites and bad sites and that only a small fraction of the total data is changed via source data verification? Resources should be focused on improving the data quality at the problem sites and we now have RBM platforms that are built to identify issues early so we can nip problems in the bud and correct bad habits.”

85. Is ClinicalTrials.gov Impacting Study Results? 9/1/2015

    Could forcing companies to report their trial methods and outcome measures prior to conducting a study actually impact trial results? According to a study conducted by PLoS ONE, the launch of the government website does seem to have had an impact on trial results. In a sample of 55 trials testing treatments for heart disease, 57 percent of the studies conducted prior to 2000 reported positive results from the treatments. In studies that were conducted after 2000, the studies reporting a positive result fell to only 8 percent. The difference is shocking, and naturally led to many questioning the possible role of the website.

86. IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For August 2015 8/28/2015

    August 2015 was an active month on Clinical Leader. The top three articles for the month covered a range of topics, including new EU regulation on harmonization, lessons learned from an initial venture into Risk-Based Monitoring, and a piece on using Source Document Verification as a quality control measure in clinical trials. If you missed any of them, please take a moment to see what everyone was excited about. 

87. Increased Access And Use Will Maximize The Value Of Data 8/20/2015

    The collection and use of data in clinical trials has changed dramatically over the years. Just 15 or 20 years ago, researchers were generating volumes of valuable data in both the lab and the clinic. Yet somehow the isolation that existed between those two worlds prevented optimal value creation (getting therapies to patients faster). The result was frustration amongst researchers and a feeling of missed opportunities.

88. Clinical Insights: Progress Being Made With Mobile Technologies 8/14/2015

    In this second part of my interview with Zaher El-Assi, president of Merge Healthcare’s eClinical division, he discusses the status of mobile technologies and wearable devices in clinical studies and the promise they hold for transforming trials via their application to Big Data.

89. Clinical Insights: Market Growth Projected In China and South Africa 8/10/2015

    Zaher El-Assi is always looking for new opportunities. The president of Merge Healthcare’s eClinical division believes China and South Africa are two interesting locations for the conduct of global trials. In this Q&A article he shares his insights on both markets, why pharma companies need to be there, and the challenges companies can expect to face.

90. Social Media: The New Clinical Research (And Marketing) Tool 8/5/2015

    As in all healthcare domains, social media can play a critical role when it comes to clinical trial planning, execution, and optimization.  There has been a huge increase in awareness of and engagement with clinical trials in the social sphere; in fact, according to data from health consumer insights firm Treato, over half of the 300,000 patient posts available online today about clinical trials were published in the last six months.