Clinical Guest Contributors

  1. The Making Of A Patient Advocate For The Clinical Trials Enterprise

    As a sea change has occurred over the last several years embracing patients as key stakeholders critical to clinical trial success, patient advocates who are knowledgeable about research have been increasingly sought after. Questions have been lightheartedly raised about how we “clone” the patient stakeholders who’ve made impact in the clinical trials enterprise (CTE) to date or create educational programs for the next generation of patients who express interest in getting involved.

  2. CRS Lawsuit: Does FDA Guidance Require More Clarity?

    The recent announcement that the watchdog group Center for Responsible Science (CRS) has filed a lawsuit against the FDA has raised some concerns in the clinical research community. The lawsuit is regarding the denial of the group’s citizen petition, which was originally submitted in June 2014.

  3. How The U.K. Became A Destination For Biosimilar Clinical Trials

    The biosimilars market is going to heat up considerably over the next three years, but is the NHS ready for the biosimilars boom?

  4. To Improve Patient Recruitment, Provide Investigative Site Contact Information

    Patients are the most fundamental part of a clinical trial. However, many do not know how to find a clinical trial and are unaware of actively recruiting clinical trials for which they may be eligible.

  5. 5 (Fairly Simple) Statistical Analysis Plan Elements To Implement In Your Clinical Study

    My father used to say, “If you are going to do something half-assed, don’t do it at all.”

  6. What Value-Based Reimbursement Means For Drug Development

    Pharmaceutical reimbursement historically has largely been a process of first determining the efficacy and safety profile of a therapy and then deciding its ultimate coverage level based on its price. But now, payers are taking a cue from their European peers and beginning to do the sophisticated number-crunching and cost-effectiveness studies to take a more holistic approach to drug coverage.

  7. 3 Steps To Capitalize On Real-World Data Under 21st Century Cures

    Randomized clinical trials (RCTs) of prescription drugs and other medical products have been considered the gold standard of evidence to support decision making by clinicians and policymakers. However, it is increasingly recognized that most RCTs are unable to generate information about a product’s real-world effectiveness. Measures such as long-term outcomes, comparisons among multiple treatment options, and utilization are not well captured in trials. Furthermore, benefit-risk balance and value for money are best learned in cost-effectiveness or cost-benefit analyses.

  8. Does The First-Patient-In Milestone Really Matter?

    Sorry, pharma executives. We have all been duped for years that the FPI milestone yields an increase in stock price and company value.

  9. Consolidation In The Core Lab Market — What Pharma Companies Need To Know

    Clinical laboratory services are the most outsourced services by pharmaceutical, biopharmaceutical, and medical device companies. Trending in the central or core laboratory services market is consolidation and integration of services through acquisitions and collaborations inorganically to expand beyond core services. Through horizontal integration suppliers increase their market share.

  10. Why Staff-Centricity Needs To Be Front And Center On Your Radar In 2018

    As 2017 comes to an end, I have been reflecting on the topics I’ve covered this year, focused mainly on patient- and site-centricity.  It occurred to me that as an industry, we’ve been missing the topic of staff-centricity for quite some time.  Patient engagement officers and related roles are becoming more commonplace, and many service providers have a variety of personnel focused on customer engagement.  But it’s rarer to hear about employee engagement officers.