Insights On Trial Design

  1. The Current Biomarker Landscape In Immuno-Oncology

    Dr. El Mustapha Bahassi, Associate Director of Clinical Laboratories at Medpace gives an overview of Central laboratories and the evolving world of immuno-oncology as well as current immuno-oncology biomarkers and detection methods.

  2. Bringing Real World Evidence Into Clinical Research

    Life sciences companies are embracing the essential roles that real world data (RWD) and the generation of real world evidence (RWE) play in the development of new treatments for patients.This paper will explore three areas where RWD and RWE are being applied to improve the design and execution of clinical studies.

  3. Confronting The Challenges Of Rare Disease

    This paper is intended as a discussion of the commonly encountered hurdles in studying rare diseases and how a cohesive and holistic approach can mitigate issues and help bring new treatments to patients.

  4. 5 Critical Steps In Developing Your Clinical Supply Chain

    Clinical supply chain planning is imperative, as it allows you to develop a strategy and best practices for quickly and efficiently delivering goods to support all the needs of the trial. But, where do you begin?

  5. Importance Of Chain Of Custody Documentation For Biologics

    Preventing patients from receiving “counterfeit, diverted, sub-potent, substandard, adulterated, misbranded, or expired drugs” is a critical element of the mission of the US Food and Drug Administration (FDA). Chain of custody for genetic and cell therapies differs and is more complex than for traditional pharmaceuticals, and the requirements for documentation vary as well.

  6. Not Enrolling Enough? How To Rescue Your Recruitment

    A common issue regarding “faltering” studies – studies that are not satisfying their time, cost, and quality parameters – is poor recruitment. Recruitment issues can delay deadlines and jeopardize the drug’s ultimate approval, if left unresolved. If your study is struggling because of recruitment issues, here are some considerations that can be used to rescue your clinical trial.

  7. Compensating Participants In Clinical Research: Current Thinking

    New research on how people make decisions about research participation, and new approaches to the question of payments and compensation to participants, bring a new perspective; are payments to participants actually too low? This paper explores this question, and whether we should, in fact, worry much less about restricting compensation for research participants.

  8. Removing Barriers: Reimbursement And Compensation For Participation In Oncology Clinical Trials

    Approximately 20% of cancer clinical trials will never be completed, because they fail to enroll enough participants to be able to answer the research question. Read this white paper to learn the impact that participant payments may play on clinical trial recruitment.

  9. Untapped Potential: Asia-Pacific’s Growing Role In Biotech Drug Research

    For all its demographic promise, the Asia-Pacific (APAC) region has been slow to emerge as a center for US and EU biotech clinical drug research. Patient access in this region is now a strong motivator. Read further observations about the future of the APAC region in biotech drug research.

  10. Is Gut Microbiome Behind Our Next Breakthrough Therapy?

    We’re now only beginning to understand how the microbiome influences our health and behavior and vice versa. As we learn more about its connection to a host of diseases and disorders, we expect to see specific bacterial molecules as potential druggable targets.