Featured Trial Design Editorial

  1. ProMIS Trial Offers Hope For Alzheimer’s Patients
    6/21/2018

    There is a large and growing unmet medical need in the U.S. for patients with Alzheimer’s disease and their care givers. A March 2018 article on Forbes notes there are now 5.7 million Americans living with Alzheimer’s due to the aging baby boomer population. The cost of caring for them has now hit $277 billion.

  2. What Would Convince You To Delay Your Trial For 12 Months?
    6/19/2018

    If you were ready to begin clinical testing on a new molecule but discovered you already had an improved version of the drug in development, would you move forward with the program or delay the Phase 1 trial by more than 12 months? That is a decision Samantha Cobb, CEO of AdAlta, had to make. Her decision centered on the well-being of patients.

  3. Clinical Trial Design Is A Two-Way Street
    6/19/2018

    You’ve heard the phrase “two-way street,” where a situation or relationship involves mutual give and take. Perhaps the first example that comes to mind is a friendship. But have you ever thought of clinical trial development as a two-way street? 

  4. What’s Next In Patient Engagement?
    6/13/2018

    Patients have an irrefutable role in shaping the care they need. We have come a long way since the days when the idea of involving patients in healthcare product development was controversial, if not unheard of. In recent years, the healthcare ecosystem, and the role patients play in it, has evolved in a promising direction, leading to a much deeper understanding of the impact the patient voice can and should have in healthcare.

  5. The Evolving Reimbursement Landscape — Considerations For Clinical Trial Design
    5/29/2018

    Sponsor companies are increasingly examining ways to integrate the payer community’s point of view into clinical development activities, a trend that could improve the chances a drug will gain market access, achieve faster adoption once launched, and better meet patient needs. With payers increasingly demanding evidence of a drug’s value before they will cover a marketed product, demonstrating both better clinical and economic benefits of a treatment takes on greater significance.

  6. Health Citizenship: A New Social Contract To Improve The Clinical Trial Process
    5/8/2018

    Over a quarter of a million clinical trials are currently registered on clinicaltrials.gov. It’s no wonder that society has high hopes for the next cure for cancer, a breakthrough in Alzheimer’s disease treatment, and more effective prevention of common conditions such as strokes.

  7. 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.

  8. 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.

  9. 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.

  10. 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?