Clinical Guest Contributors

  1. Improve Clinical Trial Design By Getting To Know Potential Participants
    8/7/2018

    A major part of the drug development process in terms of timelines and budget goes to clinical trials. It’s no secret that a clinical trial’s success is predicated on people — people participating in the clinical trial. From developing the clinical trial design to gathering the patient outcomes, it all requires patients to be fully involved and motivated to work with the clinical trial team.

  2. 3 Major Challenges With Global Clinical Trials — And How To Overcome Them
    8/2/2018

    The disconnect between increased investment/activity and output points to continuing significant challenges in the global clinical trials market. Here we examine three of the leading issues facing the biopharmaceutical industry today.

  3. 10 Key Ingredients For Small Pharma GCP Quality Systems
    7/31/2018

    Small to midsize pharmaceutical or biotech companies (small pharma) are enjoying the best of times. However, from a quality systems perspective, it could be the worst of times. Many have weak quality systems, are not following global regulatory authority regulations and/or guidance, or lack the level of documentation required to reconstruct every aspect of clinical trials.

  4. Should You Conduct Your Medical Device Clinical Trial In Latin America?
    7/30/2018

    Bilingual U.S. board-certified physicians who have a track record of research and publications and and the fact that trial costs are significantly lower in the region, makes Latin America very attractive for U.S. life sciences companies looking to conduct cost-effective and ethical OUS clinical trials.

  5. Companion Diagnostics And The Future Of Oncology Clinical Trial Design
    7/30/2018

    In previous installments of this three-part series, our colleagues explored how the shift in the U.S. from volume- to value-based healthcare reimbursement has  1) facilitated trial sponsor willingness to integrate payer community points of view by including value-oriented endpoints and other real-world evidence-generating strategies into early clinical development activities (read Part 1), and 2) placed added pressure on sponsors to reduce price while increasing overall drug benefit delivered to patients.

  6. Lessons In Patient-Centricity From Rare Disease Clinical Trials
    7/26/2018

    Patient-centricity has been defined in various ways, but we like to think of it as simply “to identify and seize the opportunity to create value for patients — and to do so with patients whenever it’s feasible.” Pharmaceutical and biotechnology companies have begun to embrace the concept relatively recently. However, the idea — and practice — has been around for a long time in other industries.

  7. 4 Keys To Making Stakeholder Partnerships Work
    7/24/2018

    Intriguing partnerships have made big headlines this year.  Retail giant Amazon bought Whole Foods.  Prince Harry, Duke of Sussex, married divorced American actress Meghan Markle.  And the president of the United States made nice with the volatile leader of a renowned nuclear threat. 

  8. A Cost-Utility Analysis Of Vertex’s CF Drugs — What It Teaches Us About Trial Design
    7/19/2018

    Commercial success in the pharmaceutical industry requires that clinical programs, in addition to demonstrating clinical effectiveness, also provide data supporting a drug’s value. The Institute for Clinical and Economic Research (ICER), a U.S.-based cost-effectiveness watchdog, recently released an analysis suggesting that Vertex Pharmaceuticals’ cystic fibrosis (CF) franchise — Kalydeco, Orkambi, and the recently launched Symdeko — while offering meaningful clinical efficacy, would require discounts of approximately 70 percent1 to be cost-effective.

  9. Adverse Event Reporting On Social Media — What You Need To Know
    7/17/2018

    Adverse events (a suspected reaction to the API or to the API in combination with prescribed medicines or environmental factors) are, naturally, a challenging situation for patients in a clinical trial and may, in rare cases, become severe or even fatal. For sponsors, contract research organizations (CROs), and logistics partners, early notification and accurate information is vital to understanding and responding to a suspected adverse event. What happens if the patient goes off protocol and turns to social media?

  10. Self-Deception — The 3 Most-Repeated Lies Of Trial Master File QC
    7/12/2018

    Achieving inspection readiness means that during all stages of a clinical trial, a regulatory inspector would be able to walk into the building and reconstruct the trial using only the documents and metadata present in the trial master file (TMF). Although the concept of an inspection-ready TMF may be simply described, inspection readiness is not easily achieved. The failure to achieve an inspection-ready TMF continues to be an area of growing risk for the clinical research industry.