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Can Data Help Improve Diversity In Clinical Trials?

Denise Bronner Ph.D., director of diversity, equity, and inclusion in clinical trials at Johnson & Johnson Innovative Medicine (JJIM) talks about some of the types of datasets that can be leveraged to improve diversity in clinical trials.

GUEST COLUMNISTS

Understanding Human Behavior To Help Improve Patient Adherence
In clinical trials, early dropout rate across all conditions still hovers around 30% and almost 70% of the protocol deviations are potentially linked to non-adherence. The BEAMER project, in part, sets to remedy that.
Release Testing Of AAV Gene Therapies For Clinical Trials
Adeno-associated virus (AAV) gene therapies that are designed to deliver a therapeutic transgene to patients are complex products that can be challenging to manufacture. Because of their complexity, a variety of analytical methods are required to ensure that these viral vectors are of high quality and purity, will function as intended, and have batch-to-batch consistency.
Improving Clinical Trials Accessibility For Patients With Disabilities
While increasing DE&I in clinical trials is essential to all individuals, this article speaks to considerations for removing barriers and improving trial accessibility for individuals with disabilities. Discussion includes combating stigma and bias, changing structural design, and more.
Identifying Digital Endpoints For Fatigue To Drive Better Clinical Care And Treatments
The absence of clear biological indicators for fatigue makes diagnosing and finding effective treatments difficult. Cambridge Cognition's Michele Veldsman, Ph.D. is working to develop better biomarkers to improve diagnosis, care, and treatment.
5 Habits For Ship-Shape Source Data
ALCOA+ — or Attributable, Legible, Contemporaneous, Original, and Accurate + Complete, Consistent, Enduring, and Available — is the basis for these must-follow tips from Moderna Senior Manager of R&D Quality Kaitlin Bova.
Addressing Barriers To Adolescent And Young Adult Participation In Cancer Trials
While the challenges of cancer diagnosis, treatment, and survivorship are well-known, adolescents and young adults (AYAs), ages 15-39, have specific hurdles. Challenges in clinical care that occur in this age group also are mirrored in research, where a deficit of AYAs are represented.
How To Measure Progress In Improving Clinical Trial Diversity
CTTI Diversity project’s makes recommendations for more diverse clinical trials and presents a maturity model to help sponsors develop or improve sustained clinical trial research infrastructure.
How Pfizer Prioritizes Diversity When Implementing Multiple Myeloma Trials
Every patient deserves the chance to feel seen, heard, and prioritized in research and care — and for Black individuals with multiple myeloma, it’s a matter of urgency.

CLINICAL TRIAL WHITE PAPERS

Reimagining Oncology Clinical Trials With Digital Biomarkers
In this paper, look at the perceived barriers to the adoption of wearables—and the major benefits that await sponsors that overcome them.

Boosting Patient Recruitment And Retention: Key Insights For Success
7/13/2023

Find out what sites, sponsors, and CROs within the global healthcare community had to say about their sentiment towards emerging clinical trial patient engagement trends in this 2023 Research Report: Global State of Patient Convenience.
Intelligent Automation For MDR & IVDR Content
6/27/2023

Learn how automation can help fulfill new MDR/IVDR requirements and optimize existing labeling and documentation operations while meeting compliance.
3 Themes And Takeaways From FDA’s Draft Guidance On DCTs
8/8/2023

Get our experts’ summary of recent regulatory guidance as well as recommendations for optimal decentralized clinical trial design and conduct.
De-Risk Development: Nonclinical Strategy And Study Design
5/18/2023

Whether you are a researcher, scientist, or industry professional, access these insightful guides and checklists that provide valuable advice and best practices for planning and executing nonclinical studies.
Machine Learning To Drive Clinical Trial Efficiency
8/16/2023

Read on as authors explore accessing real-time clinical trial data for proactive study management, using adverse event data to enhance safety and performance, and tools to improve design.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

Unraveling Duchenne Muscular Dystrophy
6/27/2023

Rare disease studies in remote locations often face logistical challenges to completion. Explore the effective impact personalized patient support services can have on clinical trial success.
College Of Medicine Sees A Cost And Resource Savings In Moving From Cash To Clincard
2/17/2023

Read about why distributing cash and checks can be extremely time-consuming, particularly when you are conducting numerous studies with hundreds of participants.
Emerging Biotech Saves Over $300K On Phase I Oncology Trial
4/24/2023

Discover how one platform was able to provide operational efficiencies, data integrity, and savings, enabling the advancement of a clinical program during economic uncertainty.
Roadmapping The Journey To Going Public For Life Sciences Companies
1/27/2022

Would going public be more manageable and low-risk if the right expertise and systems helped a company move through the process efficiently and established a firm foundation for its future? Learn more in the available article.
Solutions Support Endpoint Reliability In Pediatric Rare Disease Trial
8/15/2023

Dive into this case study where a pharmaceutical sponsor running a trial for a new treatment for a rare pediatric disease employed solutions and services dedicated to enhancing endpoint reliability.
Medicenna Gains Precedent-Setting FDA Approval
12/8/2022

Learn how Medicenna was able to leverage Synthetic Control Arm (SCA) to bolster Phase 2 findings and gain FDA approval to design a hybrid external control arm for their Phase 3 registrational trial.

More Clinical Trial App Notes & Case Studies

NEWSLETTER ARCHIVE

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CLINICAL LEADER CONTENT COLLECTIONS

With the advent of decentralized clinical trials and the increased fascination and exploration with technology-assisted processes bringing new data — and more of it — the importance of intentional data collection cannot be overstated. Our latest ebook from Clinical Leader brings you helpful articles on a topic that is arguably the most crucial part of the study process.

FOCUS ON PATIENTS

Developing A Diversity Action Plan That Actually Works

A successful diversity action plan (DAP) requires contributions of multiple cross-functional teams who are collectively well resourced and financed. Consultant Devra Densmore explains.
How To Measure Progress In Improving Clinical Trial Diversity

CTTI Diversity project’s makes recommendations for more diverse clinical trials and presents a maturity model to help sponsors develop or improve sustained clinical trial research infrastructure.
How Pfizer Prioritizes Diversity When Implementing Multiple Myeloma Trials

Every patient deserves the chance to feel seen, heard, and prioritized in research and care — and for Black individuals with multiple myeloma, it’s a matter of urgency.

EMBRACING DIVERSITY & INCLUSION

Age Diversity In Clinical Trials: Why It Matters

Clinical trials are essential for evaluating the safety and efficacy of new treatments before they are approved for use by patients. However, a new report from the International Longevity Centre (ILC), in collaboration with RBW Consulting, highlights a significant problem in the clinical trial process: the underrepresentation of older adults.
Clinical Trial Diversity, Flexibility Championed By The Food And Drug Omnibus Reform Act

The Food and Drug Omnibus Reform Act, signed into law by President Biden on Dec. 29, 2022, includes provisions intended to modernize clinical trials and are broadly divided into two categories: encouraging the enrollment of diverse populations and facilitating novel clinical trial designs.
AI And Healthcare Disparities: Driving A Wedge Or Closing The Gap?

The enthusiasm for the role of AI in upgrading global health and care provision is justified, provided we understand that the path to success is just as much about communication and collaborative development as it is about the raw potential of the technology itself. Because realizing this technological potential requires us to consider the role of people and processes in an integrated approach.