Clinical Guest Contributors

  1. The 3 Stages Of Decentralized Trial Maturity 2/1/2023

    Decentralized clinical trials (DCTs) offer clear benefits to patients and the overall success of the trial, but it can be difficult to know how to address this challenge. This three-stage framework approach will enable you to assess your organization’s current clinical trial innovation maturity and build a plan from there.

  2. The 5Vs Of Collecting Clinical Data 1/26/2023

    Not all data is created equal. Our data strategies need to be commensurate with the risks, complexity, and value of the data collected. If the true value of data is to be realized, it must be collected and captured in accordance with the five “V” dimensions: volume, variety, velocity, veracity, and value.

  3. How Flexibility Can Strengthen The Sponsor-Site Relationship 1/25/2023

    In 2020, Freenome launched PREEMPT CRC to test the early diagnosis of colorectal cancer using a multiomics platform. Leveraging key soft skills like flexibility and respect for others' differences, Freenome successfully enrolled more than 40,000 patients across 200+ sites.

  4. How One Pharma Exec Uses Her Father’s Cancer Experience To Better Patients’ Clinical Journeys 1/23/2023

    Until pharmaceutical executive Christina DiArcangelo's father became a Stage 4 oncology patient, she wasn't wholly aware of the shortcomings of clinical trials. Now, buoyed by personal experience, she's dedicating her professional and personal pursuits to improving the patient experience.

  5. Expanding Eligibility — And 6 More Tips For Improving Trial Diversity 1/20/2023

    It is no secret that people who are ethnically diverse are underrepresented in clinical trials, and that is a trend that needs to change. But how? Discover six ways you can increase trial diversity starting now.

  6. Embracing Agility In Phase 2 Clinical Trials 1/19/2023

    Phase 2 clinical trials are like software development. How so? Ivanna Rosendal explains the connection and makes the case for using a now-ubiquitous software development workflow to improve clinical data management.

  7. FDA Releases Final Guidance On Early-Phase Cell & Gene Therapy Trials 1/18/2023

    The cell and gene therapy development process involves screening different variants of a product type. To aid this process and to ensure that suitable evidence is gathered so that effective variants of the product are taken through to later-stage trials, the FDA has produced a final guidance, Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial.

  8. How Can Clinical Research Better Navigate Healthcare Deserts? 1/17/2023

    Large swaths of the U.S. remain healthcare deserts, where access to clinical sites, pharmacies, and hospitals is limited. This contributes to underrepresentation in clinical research. What are the roles of technology and community outreach, and what are some current industry efforts to address it?

  9. The Long-Term Impact Of COVID-19 On Clinical Trials: Part 2 1/16/2023

    The COVID-19 pandemic is helping create a “new normal” for the life sciences industry regarding the policies, procedures, and processes of clinical trials. In Part 1, we discussed five factors that more directly impact the clinical trial process and patients. In Part 2, we will discuss six factors that focus on organizational structure and the broader industry. 

  10. Avoid Launch Delays By Planning For An FDA-Required REMS 1/13/2023

    Picture this: The FDA accepts a manufacturer's NDA, and the manufacturer plans for its impending launch. But shortly before the anticipated approval, the FDA notifies the manufacturer that a Risk Evaluation and Mitigation Strategy (REMS) program is required to market the product. Now what?