The Basis of Conducting Clinical Trials for Medical Research

The Basis of Conducting Clinical Trials for Medical Research

If you read or listen to the news daily, you’ve likely heard reports about the latest clinical trials underway for an array of diseases and chronic conditions, from ebola to pulmonary arterial hypertension.

Clinical trials are essentially research studies that examine how patients respond to new drugs, biological products, therapies, or medical devices. During each clinical trial researchers aim to answer scientific queries as to:

  • Disease prevention.
  • New screening and diagnosis methods.
  • Compare new and old treatments to disease.

Each clinical trial has strict protocol around what type of volunteer patients vs. healthy individuals can take part, and depending on the condition, trails may require certain age groups, ethnicities, and genders. Every clinical trial in North America is overseen by a medical body (a combination of community leaders, statisticians, and physicians) known as the Institutional Review Board (or IRB) as well as regulated by the Food and Drug Administration (FDA) and the federal government, who is responsible for the review and approval of what clinical trials will take place, and also monitors each trial as far as the progress and results, concerning the following:

  • Is the study ethical?
  • Are the rights and welfare of study participants protected?
  • Are the trial risks less compared to the potential trail benefits?

Clinical research involves patients suffering from numerous diseases and chronic conditions, but it also requires healthy study participants as well in order to aid research in disease prevention, and improving the overall health care system as a whole. The most common clinical research is done on the following:

1. Health services trials
Health service clinical trials examine the efficiency of the health care system as far as costs, access to services, access to health care providers, costs, and positive and negatives outcome of health care. Findings will inform new, more efficient health care processes and outcomes.

2. Behavioral health care trials
With a rise in the rates of mental health issues in North America, behavioral health trials aim to better understand human behavior and how it’s linked to specific health conditions and diseases.

3. Epidemiology clinical trials
Epidemiology clinical research evaluates new approaches to disease prevention and treatment using randomized, controlled, double-blind trials to better understand disease causes, progression, patterns, and treatments in specific participant groups.