Regulatory Affairs Editorial

  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. 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.

  4. 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?

  5. 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.”

  6. Genelux Trials Use Vaccine Virus To Attack Tumors
    11/22/2016

    Genelux is an oncolytic virus company that was formed in 2001 and has been conducting clinical trials since 2009. The company completed four Phase 1 studies which have enabled it to design what CEO Thomas Zindrick describes as an advanced clinical program.

  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. 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.
  9. Clinical News Roundup: FDA Updates Guidance On Race/Ethnicity
    11/3/2016

    Clinical news roundup for the week of October 31, 2016 with information on FDA guidance related to race and ethnicity in clinical trials, DIA’s patient engagement study, Parkinson’s Disease Foundation funding research, age and thyroid cancer treatments, and Merck’s success with Alzheimer’s disease.

  10. Clinical News Roundup: FDA Approves Oncology Trial For Cuban Treatment
    10/28/2016

    Clinical news roundup for the week of October 23rd with information on an oncology treatment developed in Cuba, AZ suspending recruitment on two trials, an SCRS white paper on site payments, a new platform for wearables in clinical trials, the CRA shortage, and more.