Safety/Efficacy Featured Articles

  1. 3 Things You're Doing That Drive Your Sites Insane! 9/15/2016

    Many pharma companies have become focused on becoming a sponsor of choice. We believe this comes from the recognition that partnerships are a two-way street. In order for the industry to conduct trials faster, more efficiently, and at a lower cost, sites and CROs need to be better partners to pharma. At the same time, however, pharma needs to be a better partner to sites and CROs. Still, many wonder what it means exactly for a sponsor to be a better partner.

  2. SCDM Best Practices Now Available To Nonmembers 9/13/2016

    Data managers are critical to the clinical research process. It’s the data they collect which will ultimately determine whether a new drug gains FDA approval. Recognizing that, the Society for Clinical Data Management (SCDM) was established to work with the teams creating clinical trials, writing the protocols, and identifying the information that needs to be captured. Over the years, the information gathered by SCDM members has been incorporated into a guide book of Good Clinical Data Management Practices, which SCDM is now making available to nonmembers as well as association members.

  3. Patient Engagement: An Essential Strategy For Pharma 9/12/2016

    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.

  4. How To Incorporate Digital Technologies In A Clinical Protocol 9/9/2016

    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.

  5. Craftsmanship In Clinical Trial Study Design 9/7/2016

    To be a successful clinical researcher, you need to coalesce expertise across a variety of domains — statistics, data management, project management, clinical operations, product safety, regulatory, medical writing — as you design, prepare, execute, and troubleshoot throughout the trial.

  6. Can Better Patient Experiences Lead To Better Medicines? 9/7/2016

    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.

  7. Clinical News Roundup: U.S. To Start Trials For Dengue Vaccine 9/2/2016

    Clinical news roundup for the week of August 29, 2016 with articles on clinical trials for dengue vaccine, Dr. Reddy’s patient-centric platform, patient recruiting via tablet apps, Leapcure and Scientist.com partnership, Validic joining forces with SAP, and heart disease drugs in clinical trials.

  8. Israel's Emergence As A Go-To Market For Conducting Clinical Trials 9/1/2016

    Driven by the steep costs of hosting clinical trials in the United States and Western Europe, pharmaceutical companies have increasingly turned to global markets to conduct trials over the last decade. During that timeframe, Israel has emerged as an attractive market – bolstered by its high-quality medical infrastructure and well-trained physician workforce, diverse patient population and widespread adherence to Good Clinical Practice (GCP) standards.

  9. Phase I Clinical Supply Landscape: Trends, Demarcation And Security 8/30/2016

    The core addressable early phase market is USD 11.9 billion growing with a CAGR of 2 – 3 percent. Early-phase trials are outsourced at greater than 60 percent by pharma, as the trials are costly and small in number. The supply market for early phase is comprised by CROs, research centers, and academic institutes. The market size that is comprised by the CROs is estimated to be around USD 8 billion, which is about 67 percent of the early phase market.

  10. JDRF Hopes Technology Will Solve Patient Recruitment Challenge 8/30/2016

    Derek Rapp, the president and CEO of JDRF, is familiar with the challenges patients face when trying to find a trial. Rapp cites statistics noting 80 percent of all trials are delayed due to recruitment issues. Over the next decade he expects the number of trials to increase. The primary mission of JDRF is to accelerate therapies reaching the marketplace that will help patients living with diabetes and to ultimately find a cure. Therefore, anything the organization can do to speed up trials is time well spent and a win for the group and its members.