Regulatory Affairs Editorial

  1. Clinical News Roundup: What If You Set Up A Clinical Trial & Nobody Signs Up?

    Clinical News Roundup for the week of June 6, 2016 featuring new trial recruitment tools, breast cancer innovations, FDA guidelines on EHR data in trials, adaptive trials for Alzheimer’s treatments, and the NIH abandons clinical research centers.

  2. IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For May 2016

    Below are my top three articles downloaded on Clinical Leader for the month of May 2016. In case you missed them, please take this opportunity to see what everyone else was learning about Merck’s efforts to be a sponsor of choice, FDAs decision on Eteplirsen, and BMS’ success in clinical trials for Opdivo. 

  3. ASCO To Take A Closer Look At Patient-Reported Outcomes In Clinical Trials And Cancer Care

    While the annual meetings of the American Society of Clinical Oncology (ASCO) can almost always be counted on to generate news about scientific breakthroughs in understanding and treating cancer, the theme for this year’s conference goes beyond that conventional approach. ASCO 2016 Annual Meeting will prominently feature discussions about how clinicians can best integrate recent advances, and particularly how to best assess the impact on real-world patients.

  4. France Tragedy Update: Bial & Biotrial At Fault; EMA Reviews Guidelines

    After the clinical tragedy in France in January, the French Health Ministry has found blame with the two companies involved in the trial, noting Bial and Biotrial were at fault on several counts. The EU has guidelines in place to ensure that does not happen again.

  5. Clinical News Roundup: Will Changes To EU Legislation Improve Trials?

    Clinical news roundup for the week of May 22, 2016 with articles on EU legislation, five major trials set to announce results, BIO releases study on clinical success, trials in Australia, fear as a roadblock to oncology recruitment, and more.

  6. As Lawmakers And FDA Consider Patient Diversity, What Can Sponsors Do?

    Patient diversity is currently an important topic in clinical trials. The low percentage of patient participation in trials has long been a concern, but the even lower participation rates of women and other demographic groups is a bigger concern. Legislators and the FDA are now looking into ways to make trial participation more representative of the general population, but can sponsors and CROs be doing more?

  7. eSource Implementation: Where Are We Now And Where Are We Going?

    Over the last several years, life science firms have cautiously moved into the eSource arena. While companies look forward to attaining the benefits of eSource, they also have concerns over potential glitches, the impact on study teams, and regulatory issues. 

  8. BMS’ Opdivo Trials: What They Teach Us About Successful Studies

    It’s hard to ignore the news around immunotherapies to treat cancer. Opdivo is a Bristol-Myers Squibb (BMS) medicine that has been approved by the FDA for patients with previously treated advanced non-small cell lung cancer (NSCLC), metastatic melanoma, and renal cell carcinoma. Opdivo also provides a textbook lesson for sponsor companies on how to conduct a successful clinical trial.

  9. Clinical News Roundup: Industry Seeks FDA Guidance On mHealth Technologies

    Clinical Leader news roundup for the week of May 8, 2016, with articles on FDA guidance regarding mHealth technologies, Bitcoin improving transparency in trials, software to change the future of drug discovery, the growing use of wearables and social media in trials, and more.

  10. Johnson & Johnson Puts Focus On Patient Voice And Compassionate Use In Trials

    While Big Pharma discusses the importance of patient centricity and putting patients at the center of all drug discovery efforts, many still wonder if a lot of the buzz isn’t simply lip service simply masking business as usual. At the end of the day, if the patient experience is unchanged, all the talk is for naught. Johnson & Johnson is one company putting programs in place to make sure the patient voice is heard at all levels of the drug development process.