Safety/Efficacy Featured Articles

  1. Eli Lilly Steps Up Focus On Autoimmune Diseases 10/5/2016

    Managing patients having an autoimmune disease can present special challenges for researchers, from correctly diagnosing the disease to recruiting specific patients for clinical trials. I recently spoke with Chin Lee, global senior medical director in the immunology therapeutic area at Eli Lilly and Company. Lee discusses his decision to move from academia to pharma and the challenges inherent in performing clinical trials on autoimmune disease patients.

  2. How Nektar Therapeutics Improves The Transactional Outsourcing Model 10/3/2016

    As pharma’s use of CROs continues to grow, so does the talk about outsourcing models. Today, one of the most popular models seems to be highly integrated strategic partnerships. Unfortunately, that model does not work for every company. Partnering agreements often seem to be built on a broad and sustainable pipeline, but for small- and mid-sized companies, that pipeline often does not exist.

  3. The High Price Of Failed Clinical Trials: Time To Rethink The Model 10/3/2016

    Back in 2014, a study in Nature Biotech showed that only 32% of drugs have a probability of making it to Phase 3 trials, and only one in 10 drugs overall actually makes it to market. Things haven’t improved since then. BIO recently put out a study reporting that the average overall likelihood of approval (LOA) by FDA from Phase I was 9.6 percent – a 1 in 10 chance. The rate is even lower for major disease areas like oncology.

  4. Adaptive Trials: Complex But Advantageous 9/28/2016

    When I speak with pharma executives on certain topics, it’s amazing to see the difference in where companies stand in terms of implementation. Adaptive trials is one of those topics. I will talk to one executive who will tell me it is one of the trends that will most impact the pharma industry in the coming year, and then talk to another who will tell me it’s old news and something they have been doing for years. Regardless of where you stand with adoption, one thing is clear: Adaptive trials have many advantages, but are also more complex.

  5. Clinical News Roundup: HHS To Provide More Info To Patients 9/23/2016

    Clinical News Roundup for the week of September 19, 2016 with stories on HHS and ClinicalTrials.gov, FDA approval of Exondys51, DCRI coordinating National Study of Childhood Health, and the world's largest breath-based clinical trial.

  6. CROs Can Be Indispensable As Pharma Companies Focus On Value 9/15/2016

    The healthcare industry’s transition to value-based care is putting a lot of pressure on pharmaceutical companies in terms of margins and the need to demonstrate improved outcomes at lower costs. In attempting to create breakthrough therapies and “beyond the pill” solutions with fewer resources, companies are demonstrating an increased appetite for outsourcing functions – and Contract Research Organizations (CROs) could be the beneficiaries.

  7. 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.

  8. 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.

  9. 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.

  10. 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.