Safety/Efficacy Featured Articles

  1. IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For November 2016 12/9/2016

    Below are my top three articles downloaded on Clinical Leader for the month of November 2016. In case you missed them, please take this opportunity to see what everyone else was learning about the growing clinical staff shortage, how Lilly is helping physicians become researchers, and how Duke and PatientsLikeMe are bringing a novel approach to ALS trials.

  2. Clinical News Roundup: Almac And inVentiv Health Partner On IRT 12/9/2016

    Clinical news roundup for the week of December 4, 2016 with information on Almac partnering with inVentiv on IRT, ERT acquiring Exco In Touch, and the 21st Century Cures bill passing the Senate and moving on to the White House.

  3. Novartis Approach Slashes Study Startup Time 12/8/2016

    “Study startup has essentially been the same since most folks in the pharma industry can remember,” says Stephanie Petrone, executive director, medical operations for Novartis. “The paperwork is the same and the process is the same.” But now, with standard contract language and a centralized IRB, Novartis is significantly reducing the time it takes to start a study.

  4. How To Fix The Patient Diversity Problem 12/5/2016

    There are 38,000 zip codes in the U.S. today. Around 70 percent of African Americans reside in 2,500 of those codes, while half of Hispanics reside in 1,500 of them. These minority populations are served by approximately 500 hospitals and 40,000 primary care physicians. Despite the concentration of these numbers, enrolling minority patients in trials remains a challenge.

  5. Fear And Mistrust Keep Patients From Trials 12/2/2016

    African Americans constitute about 12 percent of the U.S. population, but represent just 5 percent of clinical trial participants. That figure is even worse for Hispanics, who constitute 16 percent of the population and represent only about 1 percent of trial participants. Are fear and mistrust keeping minorities from enrolling in clinical trials?

  6. How FDA Hopes To Get More Women In Clinical Trials 11/30/2016

    Diversity is important in clinical trials, and one group that has been pushing for greater diversity is the FDA. The Office of Women’s Health in the FDA, established about 22 years ago, has been given the mission of advocating for the inclusion of women in clinical trials and analyzing data for the effects of gender. “The FDA has had to evolve,” says Marsha Henderson, assistant commissioner for women’s health at the FDA. “We have evolved with the science and with public expectations.”

  7. Helping Trump Prioritize His Clinical Trials Agenda 11/21/2016

    Scrolling through my Facebook and Twitter feed in the days immediately following the presidential election, you would think the world had just ended. The next four years will certainly be a period of change. For many, change brings uncertainty and fear. But rather than speculate on what we may or may not see over the next four years, let’s focus on what we might hope to see, and what would be best for the industry.

  8. DrugDev Enters Patient Arena With SecureConsent Acquisition 11/18/2016

    As an organization, clinical trial solution provider DrugDev has placed a focus on making the lives of site personnel easier. That mentality of servicing the site has primarily focused on interactions between sponsors and CROs and how those interactions can be improved. With its acquisition of SecureConsent, that focus now includes patients as well.

  9. Clinical News Roundup: ICH Looks To Revamp GCP Guidelines 11/18/2016

    Clinical News Roundup for the week of November 14, 2016 with information on efforts of the ICH to revamp GCP guidelines, DrugDev’s acquisition of SecureConsent, and successful outcomes resulting from an adaptive trial approach.

  10. Clinical News Roundup: Artificial Intelligence Ready To Run Clinical Trials 11/11/2016

    Clinical News Roundup for the week of November 7, 2016 with information on artificial intelligence running clinical trials, the UPS acquisition of Marken, efforts to track unpublished trial data, clinical success with the Zika virus, Takeda’s digital health efforts, and more.