Featured Trial Design Editorial

  1. Can Sharing Clinical Notes Increase Patient Engagement And Retention?
    2/25/2016

    If patients are more engaged with a study, and take more of an ownership role in their health and data, it’s believed they will become more attached to the study and the treatment. Some pharma companies are even looking into the possibility of patients being able to review and delete their own data. But what about notes that are recorded by a physician during a patient’s visit to a clinic? Should that information also be shared with patients?

  2. Will Cyclobenzaprine Be A Solution For Fibromyalgia Patients?
    2/22/2016

    Seth Lederman, M.D. has worked with many patients with fibromyalgia as a physician, and knows they have waited long enough for relief from its symptoms. “Those symptoms can quickly take over their lives,” he says. “Fibromyalgia is considered to be a pain disorder but it’s much more than that.”

  3. Clinical Trial Complexity, Diversity, And Right To Try Continue To Impact Pharma
    2/16/2016

    If it’s the first quarter of a new year, chances are that Michael Martorelli and his research team at Fairmount Partners has been hard at work preparing their annual questions issue of the Pharmaceutical Outsourcing Monitor. With the latest issue addressing 16 questions addressing pharma and biopharma companies for 2016, he once again does not disappoint readers. 

  4. Biopharma Trends That Will Impact The Industry In 2016
    2/9/2016

    The beginning of the year is always a good time to take a look ahead at the trends most likely to impact the industry in the coming months. One area that is changing quickly, and which promises to impact clinical trials in the coming years, is biopharma. I recently spoke with Jim Esinhart, CEO of Chiltern, about some of these trends, including study protocols, big data, mergers, and new technologies.

  5. In Pharma Mobile Technology Makes Gains, Patient Enrollment Remains A Struggle
    2/4/2016

    A new report has been released by Insight Pharma Reports with some eye-opening results sure to get the attention of clinical executives. The Patient Enrollment & Recruitment Market Study performed a survey of 100 clinical trial professional staff members regarding their experiences with patient enrollment and recruitment.

  6. Report: EMA Recommendations Were Not Followed In France
    2/1/2016

    ANSM, the national drug safety agency in France, has issued a timeline of the events that culminated in the death of one trial participant and the hospitalization of five others at a clinical trial performed at clinical research firm BIOTRIAL. As was speculated by researchers at the UK’s Royal Statistical Society (RSS) last week, the timeline confirms that all six of the volunteers who were hospitalized after the study received an escalation of the dose at the same time.

  7. FDA Sets Priorities For 2016: Quality, Participation, Transparency
    1/25/2016

    Last year the FDA took action to support the inclusion of diverse populations in trials. Sex, age, and race/ethnicity are just three demographics the agency took a close look at in regard to trial data. In August, the agency published an Action Plan designed to address three specific priorities.

  8. Home Clinical Trial Visits – A Patient Centric Solution
    1/20/2016

    The continuing rise of patient-centricity within the drug development industry is a crucial consideration for sponsors when designing their clinical development plans. With initiatives such as the FDAs Patient-Focused Drug Development Program, patient experience and voice within a clinical trial is becoming increasingly important.

  9. MDR-TB Study Requires A New Approach To Trials
    1/19/2016

    Otsuka Pharmaceutical has been an industry leader in TB drug development for over 30 years. The company is currently focused on MDR (multidrug-resistant)-TB, which refers to a form of the disease that is resistant to at least the two main first-line drugs available on the market.

    In a recent clinical trial, many of the sites lacked proper personnel, training, and equipment. Learn how the company overcame these challenges to make the trial a success.  

  10. Do Your Clinical Trial Participants Feel Like Valued Customers?
    1/13/2016

    According to Roslyn F. Schneider MD, MSc, Global Patient Affairs Lead at Pfizer, patients can often have a feeling of being powerless, and be left with the impression they are there to serve the drug development process, and not the other way around. “There are times when it seems we are asking patients for their opinions simply so we can paste them in a pre-defined place in an existing system,” she says. “That is not how a company should be treating one of its most critical stakeholders. As an industry we need to continue to find new ways to incorporate participant feedback in a way that is good for patients, their families, and caregivers. This will be beneficial for our companies and societies as a whole since all of these stakeholders are very closely aligned.”