Clinical Guest Contributors

  1. What Can Scott Gottlieb Do To Advance The FDA & Clinical Trials?

    On May 11, Scott Gottlieb, M.D., officially became the 23rd commissioner of the U.S. Food and Drug Administration (FDA). Dr. Gottlieb has previous FDA experience, having served as deputy commissioner for medical and scientific affairs, among other positions, during the George W. Bush administration.

  2. The 2 Most (Impactful!) Patient-Centric Things That Sponsors Can Do

    Fall conference season is upon us and a cursory internet search shows no less than a half-dozen conferences focused on the topic of patient-centricity.

  3. Real-World Evidence: Lessons Learned From The ADAPTABLE Trial

    Real-world evidence is a hot topic in clinical research right now.  But too often, the massive amounts of data now available from electronic medical records used in routine medical practice are being considered to be clinical evidence to support medical decision making. However, the process of transforming these large data sources into actionable evidence that can change clinical practice is a complicated but important endeavor.

  4. Could Amazon Revolutionize The Patient Experience In Clinical Trials?

    Wall Street is wondering what’s next on Amazon’s shopping list, and pharmaceuticals may be a leading contender. Here are four patient touch points where Amazon can leverage its existing capabilities in conducting clinical trials and pharmaceutical development.

  5. The Changing Landscape Of Clinical Trials: How Leaders Should Respond

    The past several years have brought significant changes to the clinical trial landscape.  Mergers and acquisitions, new players, the rapid proliferation of technology, increased patient advocacy, and new regulatory guidelines have added to the complexity of trials and burdened resource-strapped leaders with additional challenges and risks.

  6. Conducting Clinical Trials In India: Opportunities And Challenges

    The social, demographic, and economic environments in which the global pharmaceutical industry operates are transitioning. Developed economies with ever-rising healthcare costs are looking to curb healthcare expenditures, and payer demand is moving toward a reimbursement model based on healthcare outcomes. Declining R&D productivity and the looming patent cliff are threatening the sustainability of the current pharma industry business model. Emerging markets — specifically India, given its large domestic market, product development skills, and scientific man power — offer a solution to the global pharma industry to address the challenges of growth and innovation.

  7. 7 Ways Remote Clinical Trials Will Impact Investigator Site Budgets

    With the age of remote clinical trials upon us, it bears asking: What do these trials mean for the common business-related tasks of clinical trials? One under-emphasized place of change will likely be investigator site budgets.

  8. Clinical Trial Information Sharing: A Driving Force For Effective Industry Collaborations

    The evolution and complexities of drug development have prompted biopharmaceutical organizations to seek collaboration much earlier in their research and development (R&D) programs and better appreciate the value of collaboration in areas such as study planning and start-up. These arrangements are becoming critical to business strategies for many in the industry hoping to create greater efficiencies and advance the R&D of innovative medicines. One key factor that is driving the success of these collaborations is the willingness and commitment to share information such as study materials and training documentation.

  9. Do You Really Understand Clinical Supply — And Its Impact On Your Trials?

    Clinical supplies (CS) can be a rate-limiting factor to initiation of studies because of factors such as insufficient bulk material, inadequate forecasted demand, accumulation of delays (such as manufacturing delays), or a sudden acceleration in the timeline for the study’s start.

  10. Where Trial Sponsors & CROs Go Wrong With Patient Engagement (And How To Get It Right)

    As the care partner of a two-time cancer survivor who has benefited from being in more than one clinical trial, I am passionate about banging a loud and insistent drum that more patients need to have the opportunity to get "tomorrow's medicine today." After all, isn't that what clinical trials are all about? My life partner participated in a Phase II clinical trial for chronic lymphocytic leukemia (CLL) 17 years ago — and has been in remission ever since. The combination therapy he received in that trial is now one of the standard treatments for CLL. We are both grateful. So, why are only a tiny percentage of all cancer patients participating in clinical trials?