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Related Concept Videos

Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...

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A Problem in NIH and Federally Funded Prostate Cancer Interventional Clinical Trials.

Dawood H Sultan1, Diana G Ghebrezadik2, Desiree S Smith2

  • 1Mercer University, College of Health Professions, Atlanta, GA, USA. sultan.nuba@gmail.com.

Journal of Racial and Ethnic Health Disparities
|August 8, 2023
PubMed
Summary

Federally funded prostate cancer trials rarely address type 2 diabetes (T2D) and obesity in African American men. This oversight highlights a critical gap in research funding priorities for these high-risk populations.

Keywords:
African American menClinical trialsDiabetesNIHObesityProstate cancer

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Area of Science:

  • Oncology
  • Public Health
  • Clinical Trials

Background:

  • Obesity is a significant risk factor for prostate cancer (PCa) recurrence, progression, and mortality, particularly in African American (AA) men.
  • Obesity is linked to more aggressive PCa in AA men compared to White American (WA) men.
  • Type 2 diabetes (T2D), often a consequence of obesity, further reduces survival odds for AA PCa patients.

Purpose of the Study:

  • To evaluate if federally funded prostate cancer (PCa) clinical trials have incorporated interventions for type 2 diabetes (T2D) and obesity.
  • To identify research gaps in addressing comorbid T2D and obesity within PCa clinical trials, especially for African American men.

Main Methods:

  • Analysis of completed, federally funded (NIH or other federal agency) interventional PCa clinical trials conducted in the USA.
  • Inclusion criteria: trials involving males aged 18-64 years with reported study protocols.
  • Examination of intervention modalities to determine if obesity and T2D control were addressed.

Main Results:

  • Out of 47 analyzed trials involving 5802 men (15.8% AA, 84.2% WA), none specifically targeted T2D treatment.
  • Only 4.25% of trials (2 out of 47) examined weight loss and diet interventions for obesity.
  • The majority of trials (85.1%) utilized pharmaceutical therapies or clinical procedures unrelated to T2D or obesity management.

Conclusions:

  • Federally funded PCa clinical trials show a significant deficit in addressing T2D in AA men.
  • Minimal efforts were made to control obesity, with only a small fraction of trials including relevant interventions.
  • There is a critical need for increased federal funding to prioritize research on managing comorbid T2D and obesity in AA men with PCa.