Regulatory Affairs Editorial

  1. Clinical News Roundup: Artificial Intelligence Ready To Run Clinical Trials
    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with information on artificial intelligence running clinical trials, the UPS acquisition of Marken, efforts to track unpublished trial data, clinical success with the Zika virus, Takeda’s digital health efforts, and more.
  2. Clinical News Roundup: FDA Updates Guidance On Race/Ethnicity

    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.

  3. Clinical News Roundup: FDA Approves Oncology Trial For Cuban Treatment

    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.

  4. The Benefits Of Outsourcing Clinical Regulatory Requirements

    When I sat down to speak with Paul Bridges, Ph.D., corporate VP and Interim head of PAREXEL Consulting at the 2016 DIA Annual Meeting, we had recently heard the news of Great Britain exiting the European Union. Bridges seemed to take it completely in stride, noting there will always be changes occurring that can disrupt and erect obstacles to your drug development efforts. While we can’t stop them, we can certainly take advantage of the resources available from partners to better navigate them and mitigate their effects.

  5. What Will Clinical Research Certification Mean To Pharma?

    The National Board of Medical Examiners (NBME) is a not-for-profit organization that has been around for over 100 years. Its primary mission is assessing the qualifications of healthcare professionals. More recently, the group has been looking into developing an assessment that would be helpful to clinical researchers.

  6. Clinical News Roundup: Is 80 Percent Of China’s Clinical Data Fabricated?

    Radio Free Asia (RFA) is reporting that a government investigation in China has revealed fraudulent practice on a massive scale in clinical trials. China's food and drug regulator recently carried out a one-year review of clinical trials, concluding that more than 80 percent of clinical data is "fabricated," state media reported.

  7. Adaptive Trials: Complex But Advantageous

    When I speak with pharma executives on certain topics, it’s amazing to see the difference in where companies stand in terms of implementation. Adaptive trials is one of those topics. I will talk to one executive who will tell me it is one of the trends that will most impact the pharma industry in the coming year, and then talk to another who will tell me it’s old news and something they have been doing for years. Regardless of where you stand with adoption, one thing is clear: Adaptive trials have many advantages, but are also more complex.

  8. Clinical News Roundup: HHS To Provide More Info To Patients

    Clinical News Roundup for the week of September 19, 2016 with stories on HHS and, FDA approval of Exondys51, DCRI coordinating National Study of Childhood Health, and the world's largest breath-based clinical trial.

  9. Patient Engagement: An Essential Strategy For Pharma

    For the pharma industry to improve clinical trials, as well as the entire drug discovery process, better links need to be forged with stakeholder groups. That’s the conclusion of a new report released by PwC Health Research Institute (HRI) titled, Patient Engagement: Pharma’s Strategy For Success In The New Health Economy. The report is based on an analysis of the state of patient engagement, including an analysis of 21 patient-engagement meetings and data from the FDA’s Orphan Drug Designations database.

  10. How To Incorporate Digital Technologies In A Clinical Protocol

    Mobile and wearable technologies are making their way into clinical trials, helping to produce better data and engage patients in their health and treatments. But incorporating these devices also presents additional risks. What can companies do to overcome barriers and incorporate these devices into clinical trial protocols? In this Q&A article, Dmitri Talantov, M.D., R&D Operations Innovation Medical Leader, Janssen Research & Development, LLC shares his insights.