Clinical Operations Featured Articles

  1. 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?

  2. 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.

  3. 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.

  4. 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.

  5. 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. 

  6. 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.  

  7. Study Rescue: How To Get Your Clinical Trial Back On Track 7/13/2016

    Beth Harper has devoted more than 28 years of her life to the world of clinical research, including time at a sponsor, CRO, service provider, and start-up company while also serving as an adjunct associate professor at George Washington University. She is currently president of Clinical Performance Partners, where she works with companies to optimize study feasibility and site selection and helps to improve site relationship management practices. Although her passion is to work on proactive protocol and site performance optimization strategies, she will tell you that most of her time is spent rescuing studies. In this Q&A, Harper shares her insights on the factors that will lead to a study rescue and what companies can do to prevent that situation from arising.

  8. Duke & PCORI Use EHRs To Transform Clinical Trials 7/11/2016

    PCORI (Patient-Centered Outcomes Research Institute) and the Duke Clinical Research Institute have launched the ADAPTABLE study, a patient-centric trial designed to assess the benefits and long-term effectiveness of aspirin dosing. With a budget of over $14 million, the trial will randomize and dose 20,000 patients while leveraging health systems, EHRs (electronic health records), and patients in an attempt to fundamentally transform clinical research.

  9. IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For June 2016 7/8/2016

    Below are my top three articles downloaded on Clinical Leader for the month of June 2016. In case you missed them, please take this opportunity to see what everyone else was learning about the clinical tragedy in France, using source data verification as a quality control measure in trials, and where the industry stands on eSource implementation.

  10. GSK's Bold Move Into Uncharted mHealth Waters 7/6/2016

    While some sponsor companies continue to fret over the challenges of incorporating mobile and wearable technologies into clinical trials, GSK is one sponsor that has been boldly moving forward. GSK’s thinking and efforts in this area are certainly attributes that others should emulate.