Clinical Guest Contributors

  1. Combatting The Professional Patient Problem In Clinical Trials
    12/13/2018

    Clinical research patients are compensated for their participation in clinical trials. The compensation is based on the burden the trial imposes on the patient and is vetted through an institutional review board, so patients are not overly influenced by financial gain to enroll.

  2. Can ICER Help Design Clinical Trials But Stay Independent?
    12/11/2018

    According to a report, the Institute for Clinical and Economic Review (ICER) is considering offering a service, for a fee, to pharmaceutical manufacturers whereby ICER would provide guidance on clinical trial design.

  3. Are Regulatory Agencies Prepared For A Rapidly Aging Population?
    12/10/2018

    Despite changing demographics in aging populations, regulatory guidance specific to drug development for geriatrics has been limited, with guidances dating back to the 1990s.

  4. What Do Sites Really Want From Sponsors And CROs? ACRP/Avoca Survey Explains
    12/6/2018

    The Association of Clinical Research Professionals (ACRP) and The Avoca Group surveyed nearly 300 clinical trial study site staff earlier this year to determine the most important factors for advancing quality in studies from their perspectives. A total of 151 respondents assessed sponsor organizations and 130 evaluated contract research organizations (CROs). Respondents were asked to comment on up to three companies they’d worked with during the previous 12 months.

  5. What’s In A Name? Understanding Unmet Medical Need May Help Align Prioritization Strategies
    12/4/2018

    Unmet medical need (UMN) is not a new concept, but it is an increasingly important one. Regulators and payers are nudging the industry to steer R&D investments toward areas with higher unmet need and less crowded pipelines.

  6. Sites Need Technology, Infrastructure Investments To Improve Clinical Trials
    11/29/2018

    Our industry is unintentionally discouraging clinical research sites from investing in infrastructure. As a generalization, sites have the fewest resources of all the stakeholders involved in the successful execution of a clinical research trial. Most sites are very small and struggle to break even. Most sites have little to no IT infrastructure and can’t afford to build it. Most sites have staffing models where employees and physicians have too many disparate roles and responsibilities without the support or training to be successful. Employees are shared between research and non-research functions. The thin operating margins limit sites’ ability to build a meaningful, robust infrastructure, and this limits sites’ ability to be profitable.

  7. Virtual Registries: How To Bring Patient-Centricity Into Clinical Research
    11/27/2018

    Our rapidly increasing genetic-level disease knowledge and exponential technology advances are changing the way we manage health. But we may never fully seize these opportunities if we limit our clinical research approach to past models. Changing societal attitudes around sharing personal data and new consumer technology make innovative study designs and operations possible. This includes new possibilities in designing and operationalizing patient registries by moving to “virtual” setups.

  8. One And Done: How Bad Is The PI Turnover Problem?
    11/21/2018

    It’s ruefully referred to throughout the clinical trial industry as the “one and done” phenomenon, and it’s a problem that has plagued us for years. The term refers to physicians and other medical professionals who jump into a trial to assume the duties of principal investigators (PIs). Unfortunately, many are completely or relatively inexperienced in clinical trials; they’ve taken on the role of PI in hope of adding a new revenue stream to their practice or boosting their academic credentials.

  9. Data Integrity In Clinical Trials: 4 Key Concerns Of The FDA & MHRA
    11/19/2018

    For the first time ever, GCP collaborations between the FDA and Medicines and Healthcare products Regulatory Agency (MHRA) were the focus of a workshop for the drug development industry. In what is projected to be the initial installment in a series, the FDA hosted the MHRA and invited interested individuals to join the workshop “Data Integrity in Global Clinical Trials — Are We There Yet?

  10. Implementing An End-To-End Clinical Development Process Framework
    11/13/2018

    If we take for granted that there will always be new and changing processes, systems, and digital platforms and the organizational complexity within Big Pharma will not abate, how do we ensure we optimize the entire clinical trial process and make the best use of our technology and process investments?