Insights On Trial Design

  1. Clinical Labeling: Looking Ahead
    3/18/2019

    As we enter the 2019 labeling landscape—with changing regulations and slashed submission timelines—producing labels with 100% accuracy is proving to be increasingly complex and load-bearing for clinical supply teams. In the months to come, here are a few key topics that we are keeping an eye on.

  2. Incorporating The Patient Voice To Improve Ulcerative Colitis Recruitment
    3/11/2019

    Dr. Joan Meyer, Covance Executive Director of Strategy & Planning for Inflammation, Infectious Diseases and General Medicine, discusses her team’s efforts to better understand patients’ opinions about inflammatory bowel disease trials and develop patient-centered clinical strategies to improve study recruitment.

  3. Advancing A Diabetes Multi-Registration Program
    3/11/2019

    A large pharmaceutical company asked Covance to support their studies for a diabetes Phase III program specifically to register a drug to treat Type 2 Diabetes. Read how Covance utilized its rich central laboratory services database and helped the sponsor achieve first patient in (FPI) ahead of schedule for all studies in the program and beat historical industry performance across a number of key metrics.

  4. Optimizing Protocol Design And Enhancing Patient Enrollment
    3/8/2019

    An emerging biopharmaceutical company was designing a Phase II trial in patients who had Type 2 Diabetes, Stage 3 chronic kidney disease (CKD) and macroalbuminuria. They were uncertain about how to balance the selection of the right patients for their trial endpoints with the ability to achieve rapid subject recruitment. Read how LabCorp de-identified clinical laboratory data helped evaluate the protocol feasibility and the overall design of the study while also making an adjustment in eligibility criteria was forecast to double the eligible patient pool – without impacting study endpoints.

  5. Closed Loop Technology And Integrated Expertise Mitigates Risk
    3/4/2019

    Discover how Almac helped one pharmaceutical company streamline processes and remove risk from their multiple clinical trial applications while maintaining data integrity with One Unified Clinical Trial Supply Solution.

  6. Digital Recruitment Solutions
    2/28/2019

    Whatever your goal may be, online marketing can be integrated into your strategy to help make recruitment a success this fall. Read on to learn how social media and text messaging programs can help support your traditional recruitment campaigns.

  7. Sponsor Revamps Clinical Trials Website, Sees 13% Conversion Rate
    2/25/2019

    A Top 20 sponsor, eager to be more patient centric, decided to build a new, dedicated clinical trials website. The site is mobile friendly, has a robust search function, and uses simple navigation and language. Site metrics reflect increased traffic, engagement and conversion.

  8. The Placebo Problem In Pain Research Keeping Up With The ‘Mrs Joneses’
    2/22/2019

    Pain trials are uniquely challenging because they rely so heavily on patients’ own assessments. While researchers will always need to account for the placebo effect when studying indications as subjective as neuropathic pain, there are ways to increase the likelihood of achieving objective trial outcomes.

  9. Genetic Counselors - Helping Researchers Brace For The Silver Tsunami Of CNS Disorders
    2/22/2019

    Genetic testing is making it easier to identify patients for clinical trials. However, genetic testing in the context of clinical trials raises raise important ethical issues, including ones related to informed consent and disclosure of results. Genetic counselors can play a crucial role in helping sponsors address these operational and ethical issues, making trials more efficient, more patient-centered and, ultimately, more successful.

  10. Invert To Convert: Rethinking Patient Recruitment And Enrollment Strategies
    2/22/2019

    Overall, the landscape of patient recruitment and enrollment have become highly specialized and data-driven. They demand a specialized, data-driven approach that nurtures potential participants and delivers bottom-line results, quickly and within budget. Read how an Enrollment Assistant can reduce the site’s workload, accelerate enrollment and make the entire recruitment process more efficient.