Clinical Trial Technology Editorial

  1. WIB Profile: Embrace Change Management Or Expect To Fail

    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.”   

  2. Is Impacting Study Results?

    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.

  3. Clinical Insights: Progress Being Made With Mobile Technologies

    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.

  4. Source Data Verification: A Quality Control Measure in Clinical Trials

    In an industry that seems to be focused on cutting the cost of clinical trials, it’s no surprise that reducing the amount of source data verification (SDV) performed in studies—the process of cross-referencing data recorded in a case-report form to the original source information—is an integral part of risk-based monitoring (RBM) strategies. Eliminating source data checks that do not add value to the study is certainly a breakthrough for trials where we have historically performed 100 percent data verification. After all, why verify data that we already know to be correct, and is a low risk to the study as well?

  5. Risk-Based Monitoring: Understanding The Future Of Clinical Trial Monitoring

    While risk-based monitoring (RBM) has been a popular discussion topic among the clinical research community for quite some time, sponsors and researchers have been slow to implement adaptive strategies. RBM moves away from the traditional approach of frequent on-site visits and 100 percent source data verification (SDV) toward a combination of activities, including centralized data collection and monitoring.

  6. How One Bio Company Tackled Its Data Visualization Challenge

    Data visualization is a problem for many life science companies. Being able to visualize reliable data in real-time, and make smarter decisions faster, is vital to delivering speed and quality across clinical trials.

    While many companies struggle with quality uncertainty and surfacing relevant data trends, those that specialize in rare diseases have a more unique challenge. With rare diseases, trials are open label (patients and researchers both know which drug is being administered) and non-comparative. By design, personnel have access to data in an unblended way. That provides the opportunity to see actual data as it emerges, enabling personnel to understand the data in a way that would not be possible in a blended trial.

  7. Risk-Based Monitoring: A More Strategic Approach To Site Monitoring And Clinical Data Management

    When executed properly, a Risk-Based Monitoring approach to clinical trial monitoring can aid sponsors in allocating resources more effectively, reducing costs, saving time, and improving data quality. Here’s a closer look at the practice, its future, and what it could mean for the industry.

  8. A Cost Measurement Pharma Can Live With (CROs/CMOs, Too)

    Sometimes one finds help in unusual places. This might be one of those times for Pharma, and the place could be AdverseEvents. And Pharma can turn to a more usual partner — CROs/CMOs — to positively influence what AdverseEvents measures.

  9. 6 Factors To Consider When Adopting mHealth For Clinical Trials

    From patient recruitment and retention to expedited data collection, new technologies are poised to simplify trials, create a better patient experience, and hopefully bring down the high cost of trials.

  10. Treating The Causes, Not Just The Symptoms: Using Central Analytics To Determine Errors

    Instead of treating the signs and symptoms (data errors), we need to identify and treat the causes (origins of errors), which is no small task. The advances in technology that allow us to collect substantial amounts of data, clinical trials are vastly more complex to plan and conduct, making the balance between quality and cost much more difficult.