Clinical Guest Contributors

  1. Why Are We Still Talking About Study Startup?
    10/3/2017

    Organizations are always looking to optimize the startup process so they can bring products to market quicker — getting potentially lifesaving drugs into the hands of patients is the primary goal — while also reducing each study budget so more products can be pursued to help other patient groups.

  2. Patient-Centricity: Driving Toward Value Metrics
    9/28/2017

    Patient-centricity and PCIs are emerging as high-value and high-priority industry goals. The three different approaches discussed in this article can help capture and quantify the benefits of a wide range of patient-centric initiatives in healthcare product development and health research.

  3. How Interested Is The FDA In Real-World Evidence?
    9/25/2017

    When the Clinical Leader team attended the 2017 DIA Annual Meeting in June, the topic we heard discussed more than any other was real-world evidence (RWE) — that is, information about a drug that is collected outside of clinical trials. RWE is not a new concept, but there are good reasons for all the current attention being paid to it in the pharma industry.

  4. Why Pharma Needs A New Approach To Patient Engagement In Drug Development
    9/21/2017

    Pharmaceutical companies face many challenges: developing life-changing products that meet the needs of patients, physicians, and payers; adhering to regulatory standards; and managing health technology and payer scrutiny, all while trying to satisfy investors. As drug prices seem to be continually rising, many health plans are shifting more of the cost-sharing burden to patients.  As a result, the patient is becoming more of a “consumer” in the traditional sense.

  5. Real-World Evidence & The 21st Century Cures Act — What You Need To Know
    9/19/2017

    When the Clinical Leader team attended the 2017 DIA Annual Meeting in June, the topic we heard discussed more than any other was real-world evidence (RWE) — that is, information about a drug that is collected outside of clinical trials. RWE is not a new concept, but there are good reasons for all the current attention being paid to it in the pharma industry. For one, the 21st Century Cures Act, enacted into law in December 2016, seeks to speed the FDA drug and medical device approval processes by shifting some of the evidentiary requirements, in certain instances, from clinical trials to post-market  — in other words, to “the real world.”

  6. 4 Ways To Listen Like A Linguist — And Improve Trial Inclusion
    9/14/2017

    Practical discussions around inclusion often go something like this: A sponsor is interested in anticipating potential barriers to enrollment based on a newly drafted protocol.

  7. Why You Should Care About Real-World Evidence (A Lot)
    9/12/2017

    When the Clinical Leader team attended the 2017 DIA Annual Meeting in June, the topic we heard discussed more than any other was real-world evidence (RWE) — that is, information about a drug that is collected outside of clinical trials. RWE is not a new concept, but there are good reasons for all the current attention being paid to it in the pharma industry. For one, the 21st Century Cures Act, enacted into law in December 2016, seeks to speed the FDA drug and medical device approval processes by shifting some of the evidentiary requirements, in certain instances, from clinical trials to post-market  — in other words, to “the real world.”

  8. Clinical Investigator Payment Best Practices
    9/11/2017

    Managing the investigator payment is one of the most challenging aspects of running a clinical trial. Major factors considered by pharmaceutical and biotech companies for investigator payments are therapeutic area of interest, duration of the trial, clinical phase, and patient enrollment.

  9. Can New York City Lead In Life Sciences?
    9/7/2017

    New York City has long aspired to become a life sciences hub, but while the city seems to have all the elements necessary to foster such industry growth, it has continually fallen short of this goal. 

  10. 5 Rules For Managing Relationships With Your CROs And Other Vendors In Clinical Trials
    9/5/2017

    Clinical research is becoming more and more complex due to many factors, including increased regulations, competition for patients, and cost of conducting clinical trials.  Most of the smaller pharmaceutical and biotech companies (sponsors) do not have the workforce to provide proper oversight of a clinical trial.  This forces companies to outsource much, if not all, of the trial oversight to contract research organizations (CROs) and service providers (vendors).