Featured Trial Design Editorial

  1. Follow The Leader: Why Clinical Development Must Transition From Pharma-Led To Patient-Led

    “Patient-led drug development” has matured in recent years from an industry buzzword to a maxim practiced in pockets of pharma organizations each day. Yet, much more can be learned by looking through the patient lens, deeply considering their needs, and focusing on their quality of life. In recent years, companies have galvanized their efforts to develop additional methods for gathering patient input, to redesign clinical programs that improve patient experiences, and to track surrogate measures of “patient-centricity” at key stages.

  2. Fix Patient Recruitment By Learning From Service-Based Companies

    This is part two of a three-part series that will look at how the industry is changing its perspective on patient recruitment. Maura Snyder, director of Clinical Insights and Experience at Janssen, shares some of her thoughts on the recruitment challenge and what pharma must do to overcome it. 

  3. Designing Gene Therapy Trials For Access: What Payers & Health Systems Want To See

    Gene therapy may be the next revolution in healthcare. The opportunity to cure diseases through the modification of the genome was once considered science fiction, but no longer. The United States has seen a few approvals in this area, including the approval of voretigene neparvovec for a rare form of blindness. In addition, CAR-T agents, two of which are available, have demonstrated alternative ways to treat disease by manipulating genes of different cells.

  4. AstraZeneca’s Focus on Cardiovascular, Renal and Metabolic Diseases

    Many patients who suffer from cardiovascular, renal and metabolic (CVRM) diseases face not one, but several overlapping co-morbidities that can critically impact quality of life and overall health. AstraZeneca is bringing renal into focus, by developing CVRM medicines that attempt to both answer important clinical questions and put patients’ needs first.

  5. New NonProfit Aims To Bring Data Transparency To Researchers

    In 2015, Vivli was launched as a centralized platform for those willing and able to share data. Vivli gained 501(c)(3) status, formed its executive leadership team, and held its first board meeting in 2017. That is the same year it began constructing a data sharing platform and research environment.

  6. Patient-Centricity: Lessons Learned From A Career Inside (And Outside) Big Pharma

    Today’s clinical trial partner is tomorrow’s post-approval patient. They are the experts who can shape a program over time, be a voice during the regulatory approval process, and provide insight on what other patients hope to find in a therapy.

  7. Otsuka: Real-Time Data Changes Trial Paradigm

    As the Otsuka VP of Applied Innovation and Process Improvement, Debbie Profit spends a lot of her time thinking about the future of clinical trials. “There are changes occurring in the industry that will force clinical development executives to shift their mindset,” says Profit. “I am trying to understand what clinical trial sites will look like going forward.”

  8. Can A New Dosage Form Solve The Medication Adherence Problem?

    Patient adherence to medication is a problem. The cost of medication nonadherence in the U.S. alone is estimated to be between $100 billion to $289 billion annually. The problem is exacerbated in clinical trials, where patients know there is a possibility that they are taking a placebo.

  9. Navigating The Turbulent Waters From Discovery To Clinical

    “A partnering deal with a bigger pharma company would certainly help us through [the Phase 3] process,” explains Jeff Davidson, CEO of Keystone Nano, a company that develops nanoparticles that target solid tumors by going after cancer cells and leaving the normal cells intact.

  10. Taking Control Of Quality Tolerance Limits In Clinical Trials

    The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6(R2) regulations have created a buzz within the industry regarding newly required expectations for quality tolerance limits (QTLs) when conducting good clinical practice (GCP) clinical trials. QTLs have historically been required for good manufacturing practice (GMP) activities, inferring limits at which significant actions must be taken to ensure the manufactured product achieves quality and usability limits.