Featured Trial Design Editorial

  1. Can Virtual Clinical Trials Democratize Medicine?

    There are over a quarter million active clinical trials registered with the FDA right now, up from just 1 percent of that figure at the turn of the century. It's a $65 billion industry – clinical trials alone, that is, and it's only going to get bigger.

  2. Building And Applying A Configurable Clinical Study Model

    Last month we introduced an approach for the rapid assessment and prototyping of digital and other clinical trial technologies. Advances in technologies and digital innovations targeting the clinical research environment are evolving at dizzying rates, and the need to efficiently assess and implement opportunities is greater than ever.

  3. Getting A Handle On Clinical Trial Costs

    Recently, clinical trials have become very complex affairs, especially for small and medium biotech companies. There are many factors behind this, including, but not limited to, increased costs and regulatory requirements. According to Tomasz Sablinski, CEO at Transparency Life Sciences, the cost of clinical trials increased by around 100 percent from 2008 to 2019. A study published in JAMA Internal Medicine in 2018 found that out of 138 pivotal trials assessing 59 new therapies that received FDA approval between 2015 and 2016, there was a more than 100-fold difference in the costs of clinical trials.

  4. Patient Centricity And Social Media Are Changing Patient Recruitment

    Thirty years ago, patient recruitment was a challenge for pharma companies. Today the patient participation rate in trials still hovers around five percent and is not expected to improve anytime soon. Patient recruitment remains a challenge that pharma must work to overcome.  

  5. Alzheimer’s Disease Trials: Where Do We Go From Here?

    The Alzheimer’s disease space is not an easy one for pharma companies to navigate. In 2018 alone, Lundbeck, Takeda, Merck, Janssen, AstraZeneca, and Eli Lilly and Company all faced setbacks or poor trial results. Unfortunately, few spaces in the life sciences have fathered failure to the extent that experimental Alzheimer’s drugs have. 

  6. NDA Hopes To Speed New Combination Therapy To Leukemia Patients

    In March 2019, Genentech announced the submission of a New Drug Application (NDA) to the U.S. FDA for Venclexta in combination with Gazyva. The combination therapy is for people with previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions.

  7. 4 Challenges To Overcome In Rare Disease Trials

    Albireo Pharma is a clinical-stage biopharmaceutical company that was launched in 2008. One of the company’s more promising assets, A4250, is a novel bile acid modulator that has been in development for rare cholestatic liver diseases. The product, which acts locally in the gut, can effectively drain excess bile acids that get stuck in a patient’s liver. In conducting trials with pediatric patients in this space, Albireo faces four challenges common to developers of pediatric rare disease drugs.

  8. The Benefits And Challenges Of Siteless Clinical Trials

    The costs of drug development have increased exponentially over the years, while clinical trial participation and retention have decreased.1 Sponsor companies are seeking new and innovative ways to reduce costs while increasing patient participation by becoming more patient-centric. One such method is through designing a "siteless" trial. Siteless trials offer convenience to patients while being cost-efficient for sponsors.

  9. 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.

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

    How is the industry 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.