Featured Trial Design Editorial

  1. BMS’ Opdivo Trials: What They Teach Us About Successful Studies
    5/17/2016

    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.

  2. Getz: Site Activations Hurt By Commodity Mentality
    5/16/2016

    Site activation in clinical trials is not an efficient process. Those inefficiencies delay the start of trials and are costly to sponsors, CROs, and sites. But more importantly, they keep medicines from getting to patients in a timely manner. Many of the issues are ones that investigative sites have been vocalizing for some time, but which sponsors and CROs have been slow to hear.

  3. Clinical News Roundup: Industry Seeks FDA Guidance On mHealth Technologies
    5/13/2016

    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.

  4. Merck Changes The Paradigm On Clinical Trials
    5/11/2016

    Patient centricity remains a hot topic in the clinical space, and generated a significant amount of discussion at the CROWN Congress in Philadelphia earlier this year. Few would argue this will be a critical factor in turning around patient perceptions of the pharma industry, and hopefully solve the patient recruitment and retention issues that have long plagued the industry.

  5. Johnson & Johnson Puts Focus On Patient Voice And Compassionate Use In Trials
    5/10/2016

    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.

  6. Clinical News Roundup: As Quintiles And IMS Health Merge, Should Sponsors Reevaluate Partnerships?
    5/6/2016

    Clinical Leader news roundup for the week of May 2, 2016, with articles on the merger between Quintiles and IMS Health, immuno-oncology awareness at BMS, digital human models in clinical research, matching cancer patients with trials, and more.

  7. FDA Panel Decision On Eteplirsen: Disappointing But A Big Step Forward
    5/5/2016

    A recent FDA advisory committee hearing on the Duchenne muscular dystrophy drug eteplirsen resulted in a recommendation against approval. Pat Furlong of the advocacy group Parent Project Muscular Dystrophy was disappointed in the decision, but also sees it as a big step forward for patients and caregivers.

  8. Will Disruptive Innovations Enhance Patient Outcomes?
    4/29/2016

    Disruptive innovation is a hot topic in clinical trials. So is patient centricity. While some innovations will help sponsors more effectively manage the drug development process, some are also poised to have a significant impact on patients taking part in studies. In this Q&A article, Melva Covington of Sanofi and Ross Weaver of Clinical SCORE discuss innovation, FDA mandates, and industry efforts to get patients more involved in clinical trials.   

  9. Can Digitizing Clinical Trials Help Reverse Eroom’s Law?
    4/28/2016

    Eroom’s Law models the decline in R&D efficiency of traditional pharmaceutical therapies.  Basically, it explains that even with the tremendous and continued advancements in technology—processing power, storage, and bandwidth capability (Eroom is Moore spelled backwards, as in Moore’s Law)—the R&D cost to bring a new drug to market is still increasing linearly.

  10. Disruptors In Clinical Trials: How Can Pharma Assimilate Empowered Patients?
    4/26/2016

    There is no question that patients have a greater knowledge of their diseases than ever before. Patients have been evolving over the years, but the awareness of trials amongst patients still seems to be incredibly low. Still, the rise in the use of the Internet by patients has been incredible, and the information available has changed the way patients look at their own health.