Featured Trial Design Editorial

  1. 4 Keys To Making Stakeholder Partnerships Work

    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. 

  2. A Cost-Utility Analysis Of Vertex’s CF Drugs — What It Teaches Us About Trial Design

    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.

  3. QbD In Clinical Trials: A Focused Approach To Quality Assurance And Risk Management

    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.

  4. Clinical Trials: Not Broken, But In Need Of Repair

    The many challenges sponsors face performing clinical trials led Janet Woodcock, director of the Center for Drug Evaluation and Research at FDA, to remark in 2017 that the clinical trial system is broken. But if that’s the case, how do we uncover the underlying problems and bring all stakeholders together to fix them?

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

    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. How A Digital R&D Strategy Can Improve Clinical Trial Innovation And Execution

    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.

  7. ProMIS Trial Offers Hope For Alzheimer’s Patients

    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.

  8. What Would Convince You To Delay Your Trial For 12 Months?

    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.

  9. Clinical Trial Design Is A Two-Way Street

    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? 

  10. What’s Next In Patient Engagement?

    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.