Featured Trial Design Editorial

  1. How Novartis Developed An Agile Approach To Rapid Study Startup
    9/13/2018

    Over the last four years, the U.S. Medical Operations group of Novartis Oncology — in collaboration with internal clinical partners — has been transforming the study startup process for Novartis-sponsored studies.

  2. Initiating Multinational Clinical Trials: Major Differences Between The U.S. And EU
    8/23/2018

    There are significant differences between the U.S. and the EU with respect to the process of gaining regulatory approvals for initiating clinical trials of a new (unapproved) medication. Those differences relate to the initial regulatory submission, review, and approval process and the process for obtaining institutional review board / central ethics committee approval to initiate the clinical trial.

  3. Is Genetic Testing Creating a Moral Dilemma For Clinical Researchers?
    8/17/2018

    Clinical trials are complex, but adding genomics to the equation has the potential to make them even more complicated. However, much of the genetic testing that is now being performed in the clinical space is done before a trial begins. That means companies need to do some thinking before adding a genetic test to the protocol.

  4. Better Site Communication Means Better Trials
    8/13/2018

    But what best practices can you employ to ensure you and your site personnel are seeing eye-to-eye? Carrie Melvin, VP of Global Clinical Operations at TESARO, addressed the topic at the 2018 Clinical Leader Forum in Philadelphia. Proper communication will help ensure monitors are properly trained, protocol deviations are prevented, and data is collected timely and accurately.

  5. 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.

  6. Lilly Reduces White Space For Quicker Regulatory Approvals
    7/31/2018

    The time that elapses between phases of a clinical trial can be problematic for pharma companies. Known throughout the industry as “white space”, these delays can extend the trial process, drive up the cost of studies, and delay needed medicines from reaching patients.

  7. 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.

  8. 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.

  9. 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. 

  10. 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.