Featured Trial Design Editorial

  1. 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.

  2. 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.

  3. Can Better Patient Experiences Lead To Better Medicines?

    When Thomas Goetz co-founded digital health company Iodine, his goal was to show how the patient experience is not just an optional thing to track but a requirement that sponsor companies must understand in today’s information-rich world of medicine. He is now attempting to turn patient experiences into better medicines by combining data and design to help patients locate the best treatments.

  4. mHealth Panel: Make Progress, Not Excuses

    I recently moderated a couple panel discussions at the 2016 eyeforpharma Data Quality & Technology in Clinical Trials conference in Philadelphia. One of the panels was on the use of mobile and wearable technologies in clinical studies. While many sponsors continue to cite concerns over regulatory issues, other companies are moving forward with their adoption. But what are the main concerns companies face, and how can they be best overcome?

  5. Overcome The Increasing Complexity Of Clinical Logistics

    Clinical trials have become more complex than ever. Although there is still some debate around exactly how complex they have become, trials today seem to have more endpoints, procedures, eligibility criteria, protocol amendments, and investigator sites than just 10 years ago. Add adaptive trials to the mix, and clinical supply executives have more to worry about than ever before. Perhaps it’s time to make your clinical supply chain as flexible as your trials.

  6. IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For July 2016

    Below are my top three articles downloaded on Clinical Leader for the month of July 2016. In case you missed them, please take this opportunity to see what everyone else was learning about GSK’s bold moves into mHealth, the efforts of Duke and PCORI to transform clinical trials, and the coming mHealth tsunami.  

  7. Will Liquid Biopsies Transform Oncology Clinical Trials?

    Epic Sciences says it has developed a technology that CEO Murali Prahalad believes will transform oncology trials by identifying and characterizing circulating tumor cells. Those cells have been long recognized as a key part of cancer metastasis. Tumors shed these cells into the circulatory system where they then travel to different parts of the body and, under the right conditions, become the genesis of new tumors.

  8. Can We Make Clinical Research More Useful?

    Of the approximately one million papers on clinical research published to date, most are not useful. “Waste across medical research has been estimated as consuming 85 percent of the billions spent each year,” says John Ioannidis in an article titled, “Why Most Clinical Research Is Not Useful.” He points out that most published research is false and more of it needs to be made true. If true, what can we all do to make it better?

  9. Why The Explosive Growth In Post-Approval Research?

    Post-approval research, also known as Phase 4 trials, is a segment of the clinical space that is growing very fast. Research shows that 13.7 percent of total R&D expenditure by pharmaceutical and biotechnology firms in 2014 was spent on conducting post-approval studies. In fact, post-approval research has been growing faster than any other area of clinical research.

  10. Are Your Clinical Trials Prepared For The Coming mHealth Tsunami?

    Excitement around mHealth technologies has been building for years. While initial apprehension kept many companies from jumping into the space, sensors are finally starting to make it onto patients. In this Q&A, Glen de Vries, president of Medidata Solutions, discusses progress the industry has made, concerns that remain, and what the future holds for mobile and wearable technologies.