Clinical Trial Technology Editorial

  1. Duke & PCORI Use EHRs To Transform Clinical Trials
    7/11/2016

    PCORI (Patient-Centered Outcomes Research Institute) and the Duke Clinical Research Institute have launched the ADAPTABLE study, a patient-centric trial designed to assess the benefits and long-term effectiveness of aspirin dosing. With a budget of over $14 million, the trial will randomize and dose 20,000 patients while leveraging health systems, EHRs (electronic health records), and patients in an attempt to fundamentally transform clinical research.

  2. IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For June 2016
    7/8/2016

    Below are my top three articles downloaded on Clinical Leader for the month of June 2016. In case you missed them, please take this opportunity to see what everyone else was learning about the clinical tragedy in France, using source data verification as a quality control measure in trials, and where the industry stands on eSource implementation.

  3. GSK’s Bold Move Into Uncharted mHealth Waters
    7/6/2016

    While some sponsor companies continue to fret over the challenges of incorporating mobile and wearable technologies into clinical trials, GSK is one sponsor that has been boldly moving forward. GSK’s thinking and efforts in this area are certainly attributes that others should emulate.

  4. TMF Survey: Major Changes To Clinical Operations
    7/5/2016

    Every year Veeva’s Paperless TMF (trial master file) Survey provides insights into the state of electronic TMF (eTMF) adoption in clinical trials. This year marks the third year for the survey, which explores the life science industry’s progress in streamlining clinical trials and efforts to unify clinical operations.

  5. Clinical News Roundup: FDA Issues 3 Final Guidances For Expanded Access
    6/3/2016

    Clinical news roundup for the week of May 30 2016 with articles on FDA guidance for expanded access, writing an RBM plan, fixing clinical trial reimbursement, rethinking Phase 1 trials, IBM's Watson, and more.

  6. 3 Steps For More Effective Sponsor-CRO Partnerships
    5/31/2016

    Clinical Operations (ClinOps) leaders increasingly outsource critical components of their trials. By one estimate, 75% of pharmaceutical and biotechnology companies are now outsourcing data management and over 70% are outsourcing site operations. As a consequence of the growth of this practice, effective collaboration between Sponsors and their CROs has never been more critical for achieving clinical trial milestones on-time and within budget.

  7. eSource Implementation: Where Are We Now And Where Are We Going?
    5/25/2016

    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
    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.

  9. 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.

  10. Can Exco InTouch Bring Added Value To Oracle’s InForm?
    5/12/2016

    Oracle and Exco InTouch announced a partnering agreement that will integrate Exco InTouch’s ePRO patient engagement platform with Oracle Health Sciences’ InForm electronic data capture (EDC) system. The combination of the two platforms is expected to deliver enhanced workflow efficiency in clinical trials. But is the partnership truly a win for both companies?