Featured Trial Design Editorial

  1. Science Driving Gene Therapy Development At bluebird bio
    10/3/2018

    For patients with sickle cell anemia, just getting through the day can be a struggle. Symptoms of the disease include vision problems, swelling of the hands and feet, and periodic episodes of pain that can last from a few hours to a few weeks. In this article Nick Leschly, CEO at bluebird bio, discusses the progress being made with its investigational gene therapy for sickle cell disease.

  2. What Is Real-World Evidence, Anyway? Industry Experts Weigh In
    10/2/2018

    This is the first article in a two-part roundtable Q&A on real-world evidence (RWE) in the 21st century. In this first installment, we will explore common misconceptions surrounding real-world evidence (RWE), what should be considered to achieve good real-world data (RWD) analyses, and the impact this data can have on clinical treatment and regulatory development.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.