Clinical Guest Contributors
-
Release Testing Of AAV Gene Therapies For Clinical Trials
11/29/2023
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.
-
Understanding Human Behavior To Help Improve Patient Adherence
11/29/2023
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.
-
Improving Clinical Trials Accessibility For Patients With Disabilities
11/29/2023
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
11/28/2023
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
11/28/2023
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
11/27/2023
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
11/22/2023
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
11/21/2023
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.
-
3 Steps To Improve & Measure Your Clinical Trial Patient Diversity Efforts
11/21/2023
Even with the increase in investment to improve clinical trial diversity, many clinical teams are unclear on how to develop an optimal set of metrics to measure the success of diversity initiatives. Here are three steps to support your efforts.
-
One Way To Address The Clinical Research Talent Shortage? With Nurses
11/20/2023
Now is the time to expand the clinical research talent pool by focusing on nurses, says consultant Janice "Jan" Nissen. Here, she outlines why they're a valuable resource and how to recruit them.