Clinical Guest Contributors

  1. 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.

  2. 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?

  3. 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.

  4. QbD In Clinical Trials: A Focused Approach To Quality Assurance And Risk Management
    7/10/2018

    The clinical trials enterprise has long assumed that when it comes to ensuring trial quality, data is king and more is better. Not only was it considered essential to gather detailed data on every aspect of a clinical trial, but that data had to be double-entered, checked, queried, cleaned, and validated.

  5. The Evolving Role Of Biomarkers In Oncology Clinical Trial Design
    7/5/2018

    In the first installment of this series, we explored payers’ increasing willingness to provide guidance on clinical trial design and pharma’s increasing desire to seek it. With billions of dollars potentially at stake for each party, there is growing awareness that pharma and payers cannot afford missteps in the drug development process. The traditional arm’s-length (or even adversarial) relationship between drug developers and payers is not ideal for both financial success and patient welfare.

  6. Is A Functional Service Provider (FSP) Model The Right Fit For Your Clinical Study?
    7/3/2018

    As the CRO industry continues to consolidate at breakneck speed, how pharma and biotech seek external development expertise and labor support for their potential compounds has evolved. Strategic preferred provider partnerships have often turned out to be neither strategic nor preferred, leading many companies to rethink their entire research strategy and revisit insourcing (traditional staffing) and the functional service provider (FSP) models.

  7. Email: Friend Or Foe Of Effective Communication In Clinical Trials?
    6/28/2018

    There are some easy ways to improve communication on your clinical trial. But before we get into that, let’s consider how poor communication can derail your clinical trial.

  8. How Will The Federal Right To Try Law Impact Drug Development?
    6/27/2018

    The passing of the Right to Try Act came after years of debate among politicians, the pharmaceutical industry, and other stakeholders about the potential legal, ethical, regulatory, and business impacts of RTT. That debate is unlikely to end any time soon.

  9. How A Digital R&D Strategy Can Improve Clinical Trial Innovation And Execution
    6/26/2018

    The Deloitte Center for Health Solutions recently interviewed 43 biopharmaceutical industry stakeholders to explore where the industry sees value and opportunities for using digital technologies in the clinical development process; understand reasons behind the relatively slow pace of digital adoption; and uncover strategies to overcome barriers and accelerate the use of digital in clinical trials. This is the second of two articles that shares interview findings and insights published in the new Deloitte report, Digital R&D: Transforming the future of clinical development.

  10. A Simulation-Based Approach To CRO Selection
    6/21/2018

    Protocol or clinical trial simulations have been on the radar screen of the industry for quite some time as a technique for optimizing trial design and decision making.