Clinical Trial Technology Editorial

  1. Lexicon Uses Patient Input To Support Primary Endpoint

    When Lexicon Pharmaceuticals began planning for a clinical trial on neuroendocrine tumors, there were two things it hoped to accomplish. First, it wanted to incorporate patient voice into the trial design. Second, the company wanted to incorporate some type of mobile technology into the trial to help track feedback from patients.

  2. Innovative Patient Study Examines Effect Of Drug Use In Pregnant Women

    In 2009 the European Medicines Agency (EMA) launched PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium), a new research program designed to strengthen the monitoring of the benefit risk of medicines in Europe. Stella Blackburn, vice president and global head of risk management for QuintilesIMS, was heavily involved with this groundbreaking study and discusses key findings of it with Clinical Leader.

  3. Clinical News Roundup: Almac And inVentiv Health Partner On IRT

    Clinical news roundup for the week of December 4, 2016 with information on Almac partnering with inVentiv on IRT, ERT acquiring Exco In Touch, and the 21st Century Cures bill passing the Senate and moving on to the White House.

  4. 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with information on artificial intelligence running clinical trials, the UPS acquisition of Marken, efforts to track unpublished trial data, clinical success with the Zika virus, Takeda’s digital health efforts, and more.
  5. Lilly Makes It Easier For Physicians To Become Investigators

    As the global head of clinical innovation for Eli Lilly and Company, Katherine Vandebelt knows there are many things pharma needs to do better. No drug can make it to market without first navigating the clinical trials process, which creates a burden on the physicians involved. Therefore, it should come as no surprise to anyone involved in the process that many physicians will oversee one trial and then opt to no longer take part in them.

  6. SCRS: Site/Sponsor Relationship Needs Improvement

    At the 2016 SCRS (Society for Clinical Research Sites) Global Site Summit, Christine Pierre, president of SCRS, shared the results of a survey conducted of site professionals from around the world. The survey is conducted every year, just prior to the summit, to gauge the opinion of site professionals on various issues and trends. If the results are any indication, there is still room for improvement in sponsor/site relationships.

  7. PatientsLikeMe And Duke Bring Novel Approach To ALS Trial

    Can the peptide Lunasin help to reverse the debilitating effects of ALS? After one patient (and three experts) noted it could, PatientsLikeMe and the Duke ALS Clinic decided to get involved. Their novel trial will feature an unlimited number of patients, sharing of all patient data, and electronic patient reported outcomes. It also eliminated the use of a placebo.

  8. Clinical News Roundup: Sanofi Invests To Bring Clinical Trials Home

    Clinical news roundup for the week of October 21, 2016 with information on Sanofi and Science 37 bringing clinical trials to the home, SCRS Eagle Award winners, a precision master trial for AML, promoting trials to patients, stopping the progression of Alzheimer’s disease, and more.

  9. 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.

  10. TransCelerate Seeks To Improve Clinical Trial Quality

    TransCelerate Biopharma is all about collaboration. The group’s goal is to identify, prioritize, design, and facilitate the implementation of solutions to help sponsors efficiently and effectively produce needed medicines for patients. In this interview Deb Driscoll, VP of quality assurance at Merck and lead of the TransCelerate QMS (quality management system), discusses how the initiative hopes to improve quality in clinical trials.