Featured Trial Design Editorial

  1. How Can Disruptive Trial Models Help Us Meet Patients In The Real World?
    5/3/2018

    When it comes to drug development, the pharmaceutical industry has long followed the same model for how we approach clinical trials. However, we are on the precipice of a new opportunity for the entire healthcare system in which emerging technologies can help us develop and deliver medicines to patients in more agile and efficient ways than ever before.

  2. 5 Proposed Solutions To FDA For Optimizing Clinical Trials
    5/2/2018

    Lupus is a complicated imbalance of the immune system with a spectrum of manifestations that vary from patient to patient and may change in the same person over time. This complexity makes treatment development challenging.

  3. Adaptive Seamless Design For Phase 2/3 Studies: Basic Concepts & Considerations
    4/24/2018

    An adaptive design is a design that allows for modifications to the processes and statistical procedures of a clinical trial, usually at set intervals established in the trial protocol. Adaptive designs are useful for increasing efficiency and lowering costs associated with clinical research. Studies incorporating adaptive design techniques can be useful in redirecting subject allocation to concentrate on the most promising treatments or in stopping a trial early for futility. The temporal and monetary savings resulting from adaptive designs make them of great value in drug and medical device development.

  4. How To Effectively Work Across Cultures In Global Clinical Trials
    4/12/2018

    Most of us have spoken to someone and struggled to understand an accent or word choice. Even within a country, different regions can have unique language. So how do you coordinate complex projects across countries and regions, accounting for the differences in culture and honoring common objectives?

  5. “Acceptable Risk” Reduces Clinical Development Time
    3/20/2018

    We learn about risk from a very young age. If you take a good risk and it pays off, you are rewarded. Bad risks can often result in punishment. Can the use of “acceptable risk” also allow us to cut the duration of clinical trial timelines?

  6. A Practical Framework For Assessing Risk In Clinical Trials
    3/15/2018

    The purpose of a comprehensive assessment system is to support structured, systematic, objective, and rational decision making. This holds true even when assessing something as difficult to pin down as risk. 

  7. Ensure A Smooth Start-Up In Gene Therapy Trials
    3/12/2018

    Preparations for a large Phase 3 clinical trial will always present challenges. In the area of gene therapies, those challenges can be magnified. Gene therapy trials can add more time and cost to a trial, and will also require specific expertise not needed in small molecule and biologics trials.

  8. Are You Properly Engaging Your Clinical Pharmacology Team?
    3/5/2018

    Robert Homolka, Director of Clinical Pharmacology Operations at Shire, feels the support the Clinical Pharmacology group provides to the clinical development programs is one of the more important aspects of his job. Studying and ensuring the safety of a drug is of primary importance to the sponsor, and clinical pharmacology is front-and-center in leading that effort.

  9. BMS Invests Record $3.6 Billion In Immuno-Oncology Pathway
    2/15/2018

    Bristol-Myers Squibb (BMS) and Nektar Therapeutics have announced a partnership deal worth up to $3.6 billion that will lay out a new path for immuno-oncology (I/O) combination therapies.

  10. Cell Therapy Trial Creates Skin Cells For Rare Disease Patients
    1/24/2018

    Abeona Therapeutics recently conducted a Phase 1/2 clinical trial for individuals with Recessive Dystrophic Epidermolysis Bullosa (RDEB). RDEB is an often fatal connective tissue disorder marked by skin blistering and caused by a lack of a collagen protein responsible for anchoring the dermal and epidermal layers together.