Data Standards Featured Articles

  1. NEWS ROUNDUP: Precision Medicine And Patient Data, FDA Accuses CRO Of Data Fudging 4/22/2016

    Clinical Leader news roundup for the week of April 18, 2016, with articles on precision medicine and whether it can compromise patient data, FTC help for mobile health app developers, retrospectively registered clinical trials, stem cell research and clinical trials, new patient engagement tools, and data fudging in India.

  2. The True Disruptors In Clinical Trials: Insights From Agile, Merck, BI, And EMD Serono 4/21/2016

    Innovation is shaking up the world of clinical trials. Advancements in technology are rapidly changing the landscape of data collection and analysis, while patients and patient advocacy groups do their best to get their voices heard in the process of planning and executing trials. But while we often hear references to disruptions in clinical trials, it can often be difficult to identify exactly what is disrupting the process.

  3. NEWS ROUNDUP: Santa Claus, The Easter Bunny, And Patient Centricity? 4/11/2016

    Clinical Leader news roundup for the week of April 4, 2016, with articles on Patient recruitment via Twitter, NIH sponsors trial of anti-HIV antibody, diversity in clinical trials, INC Research partners with CISCRP, the use of apps in clinical trials, and the myth of patient centricity.

  4. EMRs Will Revolutionize Clinical Trials…But Don't Hold Your Breath 4/7/2016

    Will EMRs revolutionize clinical trials? The answer to that question might be a yes or no, depending on who you talk to. “People in this industry talk about how great it would be if EMRs could talk to each other,” says Ed Seguine, CEO of Clinical Ink. “But when you look at what is going on in the real world, two hospitals across the street from each other cannot get their EMRs to work together.

  5. In A Clinical Trial, Can Fitness Trackers Actually Track Fitness? 3/31/2016

    Many in the clinical space have been anxiously waiting for wearable devices to make it into clinical trials. The benefits they might provide to patients can be great, and we seem to be solving problems related to privacy and data collection. But how accurate are many of the devices currently on the market?

  6. Is Inefficient EDC Technology Holding Back The Paperless Revolution? 3/16/2016

    When it comes to clinical trials, the pharma industry has talked about making them paperless for more than a decade. But today it remains a problem the industry seems unable to solve. “Nothing has fundamentally changed in how we conduct clinical trials,” says Ed Sequine, CEO of Clinical Ink. “We seem to be waiting for new solutions to emerge, even as we continue to do the same things over and over again.”

  7. Is Outcome Switching Still A Problem In Clinical Trials? 3/7/2016

    The scientific method is pretty straightforward. Ask a question, conduct background research, construct a hypothesis, perform an experiment to test the hypothesis, and determine if the data supports or rejects the hypothesis. Unfortunately, many are questioning whether altering the hypothesis, something known in the life sciences as outcome switching, is a problem in clinical trials.

  8. Can Digital Health Data Integration Lower The Cost Of Drug Development? 3/2/2016

    John Reites, head of Digital Health Acceleration at Quintiles, has spent years working on mobile health technologies. He defines digital health data integration as the collection of data from a variety of sources, including digital health, mobile apps, and wearables. The data collected is put into an efficient ecosystem enabling pharma to analyze and understand it. In theory then, digital health data integration allows pharma to collect data from patients in a myriad of different ways between their visits to a clinical site. 

  9. Data Security In Mobile Health Apps: Does Perception Match Reality? 2/29/2016

    The use of mobile apps has exploded in recent years. One report, put out by mobile analytics firm Flurry, shows app usage grew by 76 percent in just 2014 alone. Health and fitness apps were one of the leading categories, showing growth of 89 percent. With the number of apps in the Google Play store exceeding 1.6 million, and the number of app downloads projected to hit 268,692 million in 2017, the use of mobile technologies will not slow anytime soon.

  10. Report: Pharma Is Most Resistant To Mobile Technology Use In Clinical Trials 2/17/2016

    There are several technologies that promise to improve the ease and efficiency of conducting clinical trials in the future. The one that seems to hold the most potential for also easing the burden on patients, and helping sponsors with patient recruitment and retention, is mobile health technologies. But is the adoption rate of mHealth in clinical trials increasing?