Featured Trial Design Editorial

  1. Speeding Research With Data Mining Expertise

    According to The STM Report (2015), more than 2.5 million peer-reviewed articles are published in scholarly journals each year. PubMed alone contains more than 25 million citations for biomedical journal articles from MEDLINE. The amount and availability of content for clinical researchers has never been greater – but finding the right articles to use is becoming more difficult.

  2. The True Disruptors In Clinical Trials: Insights From Agile, Merck, BI, And EMD Serono

    Innovation is shaking up the world of clinical trials. Advancements in technology are rapidly changing the landscape of data collection and analysis, while patients and patient advocacy groups do their best to get their voices heard in the process of planning and executing trials. But while we often hear references to disruptions in clinical trials, it can often be difficult to identify exactly what is disrupting the process.

  3. In A Clinical Trial, Can Fitness Trackers Actually Track Fitness?

    Many in the clinical space have been anxiously waiting for wearable devices to make it into clinical trials. The benefits they might provide to patients can be great, and we seem to be solving problems related to privacy and data collection. But how accurate are many of the devices currently on the market?

  4. France Tragedy Reminds Us Phase 1 Researchers Must Live With Tragic Results

    The recent clinical research tragedy in France that resulted in the death of one patient and the hospitalization of four others shocked many who work in the clinical research space. The adverse effects experienced by the previously healthy patients, reportedly involving deep brain bleeds, were both rare and disturbing.   

  5. FDA And NIH Release Draft Clinical Trial Protocol Template

    The FDA and NIH are requesting public comment on a draft clinical trial protocol template that has been released for Phase 2 and Phase 3 IND (investigational new drug)/ (investigational device exemption) studies. The template contains instructional and sample text for NIH funded investigators to use when writing protocols. 

  6. The Future Of Data And Technology In Clinical Trials

    In advance of its upcoming Data & Technology in Clinical Trials 2016 conference, eyeforpharma has released a report on the future of data and technology adoption in clinical trials. An Industry View Point: The Future of Leveraging Data & Technology in Clinical Trials takes a detailed look at the impact of data collection and analysis methods, current challenges, and patient centricity.

  7. Allergan’s Open Science Business Model Leads To Successful IBS Study

    In January 2016, The New England Journal of Medicine published the results of a pivotal Phase 3 study of VIBERZI (eluxadoline), a treatment for adults suffering from irritable bowel syndrome (IBS) with diarrhea. The results were from two randomized, multicenter and multinational double-blind, placebo-controlled trials.

  8. France Tragedy: Molecule Likely Caused “Off Target” Effect

    While many questions still surround the clinical tragedy in France, which resulted in the death of one patient and the hospitalization of four others, it seems certain at this point that the molecule administered to the patients is to blame.

  9. Quintiles VP: We Must Transform Clinical Development To Meet Challenges

    Making his introductory remarks as Chairperson for the 5th Annual CROWN Congress in Philadelphia earlier this year, Martin Giblin, VP of Data Science, Safety and Regulatory Operations for Quintiles, painted a bleak view of some of the challenges currently facing the pharma industry, and what we must do to meet them.

  10. New Biologics Create Need For Patient-Friendly Injectors

    Analysts forecast that by the end of 2016, 50 percent of the top 100 drugs on the market will be biologics. Currently more than 900 biologic drugs are in development to treat a broad range of conditions, including cancers, immunologic disorders, and rare and chronic diseases. That the majority of new injectable treatments are biologics will present a new challenge in delivery of the medicines.