It is well known that certain ethnic groups are routinely underrepresented in global clinical trials. But another data set now shows that some of those ethnic groups are also disproportionately consuming pharmaceuticals. Vladimir Misik, of VIARES Academy, explores why that is — and how to rectify it.
- Faster, Easier, and More Anxiety-Inducing: Are DHTs Harming Patients’ Mental Health?
- The 3 Stages Of Decentralized Trial Maturity
- The 5Vs Of Collecting Clinical Data
- How Flexibility Can Strengthen The Sponsor-Site Relationship
- How Do Cell & Gene Therapy Requirements Differ Between FDA & EMA?
- How One Pharma Exec Uses Her Father’s Cancer Experience To Better Patients’ Clinical Journeys
- Expanding Eligibility — And 6 More Tips For Improving Trial Diversity
GUEST COLUMNISTS
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How Do Cell & Gene Therapy Requirements Differ Between FDA & EMA?
This article examines the similarities and differences between how the FDA and the European Medicines Agency (EMA) approach cell and gene therapies. Where do the regulatory perspectives align and where do they diverge?
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How One Pharma Exec Uses Her Father’s Cancer Experience To Better Patients’ Clinical Journeys
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.
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Expanding Eligibility — And 6 More Tips For Improving Trial Diversity
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.
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Embracing Agility In Phase 2 Clinical Trials
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.
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The Holistic Guide To Supply Chain For Cell & Gene Therapy Startups
How does the cell and gene therapy supply chain team stay ahead of the expected changes and respond at the speed the developing program expects? Supplier selection, raw materials, built-in quality, warehousing and logistics, and traceability are all covered in this article.
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FDA Releases Final Guidance On Early-Phase Cell & Gene Therapy Trials
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.
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How Can Clinical Research Better Navigate Healthcare Deserts?
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?
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The Long-Term Impact Of COVID-19 On Clinical Trials: Part 2
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.
CLINICAL TRIAL WHITE PAPERS
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Insights On Clinical Trial Enrollment: Where We Are As We Head Into 2022
Explore the continued impact of the pandemic on clinical trial enrollment in Phase II and III studies to help the industry navigate the dynamic landscape in 2022 across four therapeutic areas (TAs).
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Accelerate Clinical Development With Patient-Centered Digital Endpoints12/16/2022
While biomarkers have improved trial efficiency in some cases, delve into why patient-centered clinical outcome assessments remain essential.
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How An AI/ML Data Strategy For Life Sciences Can Deliver Better Business Outcomes2/22/2022
Explore how data science and artificial intelligence / machine learning (AI/ML) driven predictive and prescriptive insights can help research teams cut the time and cost.
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The Rise Of Risk-Based Monitoring In The Clinical Trial Landscape5/25/2021
Risk Based Monitoring (RBM) is beginning to feature prominently as the go-to monitoring solution for clinical trials, combining the best of existing monitoring methods with the flexibility needed to keep studies on track.
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The Clinical Development Plan: Ensuring Success2/17/2022
For an early-stage pharma/biotech company, the Clinical Development Plan (CDP) can be extremely valuable and a key indicator of potential success of a program. This white paper highlights key components for developing and executing a clinical research strategy once the plan is in place.
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Fixing The Problem Of Representation In Clinical Research10/21/2021
The lack of demographic representation in clinical trials is a long-felt and well-known challenge for the research community. Whether the underrepresented communities are defined by gender, race, ethnicity, or socioeconomic status, their access is insufficient. Explore the challenges and data-driven strategies for recruitment.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Integrating Early-Phase Development Clinical Supply Manufacturing & Distribution5/10/2022
A tablet formulation was a solution when developing a new class of anti-infective medicine, allowing the integration of formulation development, clinical trial material (CTM) manufacturing, and supply and distribution to patients.
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Expanding Flexibility Of eCOA Data Collection With Controlled Interview Mode1/31/2022
By allowing the collection of ePROs by trained personnel during a remote interview, discover how the interview mode constitutes an additional data entry mode when clinical trial participants cannot go to the study site for a scheduled visit.
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Patient-Centric Approach And FDA Expertise Lead To Orphan Approval3/1/2022
An international company developing an orphan drug product needed a partner experienced in FDA interactions to help it navigate the U.S. regulatory process from beginning formulation to NDA approval. Find out how this was done in the available case study.
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Gaining Regulatory Approval Following A Single-Arm Phase I/II Study3/23/2022
A small biotech company engaged Veristat early in clinical development for help with a novel biologic being tested for treatment of an ultra-rare and aggressive hematologic malignancy with no available effective therapies. Discover what happens in this case study.
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Recruiting For Rezolute’s Pediatric Congenital Hyperinsulinism Trial6/13/2022
Rezolute faced a challenging task— to recruit pediatric patients for a clinical trial of an ultra-rare disease. In addition, Rezolute wanted to increase global awareness of the trial. Learn how a three-pronged approach was used to address these challenges and achieve randomizations.
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How Advocacy Groups Can Motivate, Mobilize Patients To Participate In Clinical Trials11/19/2021
Patients look to disease and advocacy groups as trusted resources, particularly when it comes to clinical trials. These groups have a responsibility to provide accurate, up-to-date clinical trial information — and counter misinformation. Communication is key.
NEWSLETTER ARCHIVE
- 02.07.23 -- How BMS Uses AI To Improve Study Design And Reduce Costs
- 02.07.23 -- Clinical Supply: Reducing Risk For Late Phase Delays
- 02.06.23 -- Raising Minority Enrollment With Creativity & Collaboration
- 02.03.23 -- 4 Pitfalls To Avoid With RWD For Regulatory Submissions
- 02.03.23 -- Gain Experience With Consulting & Regulatory Partners For Your Clinical Trials
CLINICAL LEADER CONTENT COLLECTIONS

The articles in this e-book all relate to the challenge of CRO selection. We hope you enjoy them and learn from the insights contained in them.
More Content CollectionsFOCUS ON PATIENTS
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Digital health technology (DHT) filled the communication gap created by physical distance during the pandemic, but have we created more space between participant and provider as we increasingly introduce and rely upon technology?
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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.
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Drug developers often talk about “patient centricity,” but most find it challenging to prioritize a patient-centric research approach in the earlier phases of drug development. A good place to start is by collectively measuring what matters most to patients — and COAs help get us there.
EMBRACING DIVERSITY & INCLUSION
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It is well known that certain ethnic groups are routinely underrepresented in global clinical trials. But another data set now shows that some of those ethnic groups are also disproportionately consuming pharmaceuticals. Vladimir Misik, of VIARES Academy, explores why that is — and how to rectify it.
-
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.
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With all the focus on patient diversity, are we actually seeing more diverse clinical trials? The answer might surprise you. Hear from Van R. Johnson as he shares meaningful and personal insights to help increase minority enrollment in clinical trials.