Safety/Efficacy Featured Articles

  1. Novartis: Pragmatic Clinical Trials & RWE Gain Traction 8/28/2017

    In this Q&A, Sameer Tandon, head of strategic alliances and customer transactions in U.S. medical affairs for Novartis, shares some of the challenges of his job and what trends will shape the future of the medical affairs group. Tandon discusses real-world evidence, FDA, payers, working with CROs, procurement costs, and more.

  2. Senate Revises Right-To-Try, CUPA Still Gives Thumbs Down 8/21/2017

    In August, the Senate passed, via unanimous consent, a bill that claims to improve access to experimental drugs for patients. While the Senate made numerous changes to the original Right-To-Try (RTT) bill, the New York University School of Medicine Working Group on Compassionate Use and Pre-Approval Access (CUPA), which came out against the bill advanced by the House, remains steadfast in its opposition to the legislation.

  3. Looking For Hep C Patients? Try Your Local Prison 8/10/2017

    There are currently 2.7 million to 3.9 million Americans with hepatitis C. Many do not show symptoms until the disease is in its advanced stages, and more than half of those with the disease have not yet been diagnosed. This year alone, 19,000 Americans will die of complications from the disease. But what you may not know is that nearly one in five Americans with hepatitis C will spend time behind bars each year.

  4. DIA Trends: Technology, Trial Design, & Regulators 8/8/2017

    In his role as SVP and managing director, Americas for DIA Global, Sudip Parikh has the opportunity to look across the pharmaceutical industry at what companies are doing in regard to clinical trials. In this article, he shares his insights into what the industry can do to make trials more efficient and speed up the entire trial process.

  5. Clinical News Roundup: LabCorp To Acquire Chiltern 8/4/2017

    Clinical News Roundup for the week of July 30, 2017 with information on LabCorp acquisition of Chiltern, merger of INC Research and inVentiv Health, FDA Reauthorization Act, Right-To-Try legislation, and more.

  6. Use Extension Studies To Enhance Phase 3 Data 8/3/2017

    An open-label extension study is one that will lie between a double-blind, randomized controlled drug trial and FDA approval. The primary objective tends to be very different from a typical Phase 3 study, as the focus is on collecting more rigorous information on the long-term safety and tolerability of a new drug. These studies present unique challenges relating to study start-up, contracts, and selection criteria.

  7. Should We Rethink Randomized Clinical Trials? 8/1/2017

    If we want to accelerate the drug development process, is it time to reconsider randomized clinical trials? That was the main question asked at a recent colloquium that included industry leaders from pharma networks, academia, patient groups, major medical centers, and the FDA.

  8. Janssen's Encouraging HIV Vaccine Trial Results 7/26/2017

    Johnson & Johnson announced encouraging clinical data from a first-in-human study for an investigational HIV-1 vaccine regimen. The vaccine regimen, in development at Janssen Pharmaceutical Companies, appeared to be well-tolerated by subjects and elicited HIV-1 antibody responses in 100 percent of the participants.

  9. Analgesic Trials: Improving The Quality Of Patient-Reported Outcomes With Central Rating Review Part 2 7/12/2017

    One of the factors contributing to the risk for sponsor companies in analgesic trials is the difficulty in measuring the severity of pain symptoms during trials in a valid and reliable way. The experience of pain is, of course, subjective and is more receptive to placebo response than any other symptom (Gracely, 2009; Berthelot, 2011). Meanwhile, the scientific community has conflicting views on the validity and reliability of Patient-Reported Outcome (PRO) assessments gathered directly from patients. Read how sponsors can ensure that PRO assessments are scientifically sound and will support evidence requirements for marketing approval and reimbursement. Part two of a two part series.

  10. Analgesic Trials: Improving The Quality Of Patient-Reported Outcomes With Central Rating Review 7/12/2017

    One of the factors contributing to the risk for sponsor companies in analgesic trials is the difficulty in measuring the severity of pain symptoms during trials in a valid and reliable way. The experience of pain is, of course, subjective and is more receptive to placebo response than any other symptom (Gracely, 2009; Berthelot, 2011). Meanwhile, the scientific community has conflicting views on the validity and reliability of Patient-Reported Outcome (PRO) assessments gathered directly from patients. Read how sponsors can ensure that PRO assessments are scientifically sound and will support evidence requirements for marketing approval and reimbursement. Part one of a two part series.