Featured Trial Design Editorial

  1. Study Rescue: How To Get Your Clinical Trial Back On Track

    Beth Harper has devoted more than 28 years of her life to the world of clinical research, including time at a sponsor, CRO, service provider, and start-up company while also serving as an adjunct associate professor at George Washington University. She is currently president of Clinical Performance Partners, where she works with companies to optimize study feasibility and site selection and helps to improve site relationship management practices. Although her passion is to work on proactive protocol and site performance optimization strategies, she will tell you that most of her time is spent rescuing studies. In this Q&A, Harper shares her insights on the factors that will lead to a study rescue and what companies can do to prevent that situation from arising.

  2. Clinical News Roundup: Should You Be Concerned About For-Profit Review Boards?

    Clinical News Roundup for the week of July 4, 2016 featuring for-profit institutional review boards, inefficiencies in clinical trials, smarter approaches to oncology trial design, clinical trial logistics, and integration between ClinicalTrials.gov and Drugs@FDA.

  3. GSK’s Bold Move Into Uncharted mHealth Waters

    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. With Aspire, BMS Puts Focus On Clinical Sites And Patients

    Patient and site relationships are a primary concern to pharma and bio companies. The desire to be a sponsor of choice to both groups, as well as CRO partners, is suddenly a hot trend in the industry. Bristol-Myers Squibb saw both of these trends coming years ago, and has been taking steps to improve those relationships.

  5. Iroko Uses Event Monitoring System To Power Phase 3 Trial Of VIVLODEX

    In a recently completed Phase 3 trial, efficacy was demonstrated in patients with osteoarthritis pain who were treated with VIVLODEX, a low-dose SoluMatrix NSAID product. The Medication Event Monitoring System (MEMS) was used in the study to accurately track when patients required additional pain-relieving medication and to show that patients using VIVLODEX required less rescue pain medication.

  6. Are You Familiar With The Framework For First-In-Human Testing?

    Although first-in-human dosing is a critical event in the clinical development pathway, Roger Mills believes few clinical trial personnel are familiar with either the theoretical or practical aspects of early human studies. A paper written by Jonathan Kimmelman titled “A Theoretical Framework for Early Human Studies: Uncertainty, Intervention Ensembles, and Boundaries” lays out some of those aspects.

  7. IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For May 2016

    Below are my top three articles downloaded on Clinical Leader for the month of May 2016. In case you missed them, please take this opportunity to see what everyone else was learning about Merck’s efforts to be a sponsor of choice, FDAs decision on Eteplirsen, and BMS’ success in clinical trials for Opdivo. 

  8. France Tragedy Update: Bial & Biotrial At Fault; EMA Reviews Guidelines

    After the clinical tragedy in France in January, the French Health Ministry has found blame with the two companies involved in the trial, noting Bial and Biotrial were at fault on several counts. The EU has guidelines in place to ensure that does not happen again.

  9. As Lawmakers And FDA Consider Patient Diversity, What Can Sponsors Do?

    Patient diversity is currently an important topic in clinical trials. The low percentage of patient participation in trials has long been a concern, but the even lower participation rates of women and other demographic groups is a bigger concern. Legislators and the FDA are now looking into ways to make trial participation more representative of the general population, but can sponsors and CROs be doing more?

  10. As CROs Merge, How Should You Assess And Manage Your Partners?

    Consolidation in the life sciences industry is a fact of life. The recent merger of Quintiles and IMS Health is just the latest in a string of consolidations. Research firm ISR Reports anticipates the merger activity will continue, with large CROs adding companies with complementary services and midsized CROs attempting to quickly gain scale. For sponsors, is this a good time to reevaluate existing CRO relationships?