Clinical Guest Contributors

  1. ClinicalTrials.gov: To Get Better Results, Talk To The Real Audience
    10/11/2018

    While controversy continues to simmer over who is accountable for posting results on ClinicalTrials.gov, perhaps the “results debate” masks the more challenging problem: ClinicalTrials.gov is not working for its intended audience.

  2. Why All The Hype Around Real-World Evidence? Here’s What You Need To Know
    10/9/2018

    This is part 2 of a two-part roundtable Q&A on real-world evidence (RWE) in the 21st century. In this installment, our experts discuss how RWE is utilized, why real-world data (RWD) analyses are getting more attention, and what the recent attention means for the future of medical practice and drug development. RWD analyses are utilized to generate insights about a medicine’s effectiveness, safety, and associated costs.

  3. R&D Data Sharing: Where We Are & Where We Need To Go
    10/4/2018

    The clinical research industry has been slow to efficiently use and repurpose data collected in clinical trials. The lack of ease, both from an ethos and technical perspective, with which pharmaceutical companies can access and share data can lead to lengthier product development, untapped study findings, and reduced collaboration between industry stakeholders. As trials become increasingly complex and costly, it is especially important to develop approaches that facilitate and encourage R&D data sharing. This not only helps clinical trial sponsors to create better informed clinical development plans and run smaller, more efficient trials, but allows patients to enroll in trials sooner and, therefore, bring innovative new therapies to the market faster.

  4. What Is Real-World Evidence, Anyway? Industry Experts Weigh In
    10/2/2018

    This is the first article in a two-part roundtable Q&A on real-world evidence (RWE) in the 21st century. In this first installment, we will explore common misconceptions surrounding real-world evidence (RWE), what should be considered to achieve good real-world data (RWD) analyses, and the impact this data can have on clinical treatment and regulatory development.

  5. 5 Major Challenges In CRO Outsourcing — And How To Overcome Them
    9/27/2018

    This is part 3 of a three-part article series on how best to procure, manage, and implement best practices in the complicated CRO market.

  6. Monitoring Adverse Event Reporting On Social Media — Should You Outsource?
    9/25/2018

    The ubiquitous nature of mobile devices means mining and monitoring social media channels and managing the challenges associated with them through technology, process management, and tactical outsourcing need to be considered standard operating procedure for clinical trials professionals and organizations.

  7. Beyond Informed Consent — How To Better Engage Millennials (And Others) In Clinical Trials
    9/20/2018

    Companies developing new healthcare products for Millennials have implemented a lot of the pieces of the puzzle of how to serve them better; unfortunately, disconnects in how those pieces link together to track the entire patient journey reduce the effectiveness of those efforts.

  8. How Novartis Developed An Agile Approach To Rapid Study Startup
    9/13/2018

    Over the last four years, the U.S. Medical Operations group of Novartis Oncology — in collaboration with internal clinical partners — has been transforming the study startup process for Novartis-sponsored studies.

  9. Clinical Trial Networks: Overcoming The Complexities Of Regenerative Medicine Studies
    9/13/2018

    The FDA’s RMAT and breakthrough designations have created a streamlined environment for product sponsors. To effectively leverage this regulatory policy environment, sponsors must conduct high-quality clinical trials that are often operationally complex. Clinical trial networks, capable of managing the array of regenerative medicine technologies, are well suited to manage this complexity.

  10. 5 GCP Compliance Mistakes To Avoid With Job Descriptions, CVs, & Org Charts
    9/11/2018

    When it comes to GCP audits and inspections, low-hanging fruit says a lot about the tree.