Since clinical trials are at the heart of what we do here at New England Research Associates, we thought we would talk about two of the basics of clinical trials; Clinical trial types, and clinical trial phases. Clinical trials help advance treatments for different conditions and can be done with or without an investigational medication or device.

Clinical Trial Types

Clinical trials can either be categorized into interventional or observational. Interventional trials evaluate a new investigational drug or device, a new medical procedure, or even compare different interventions to each other, to name a few. Observational trials are when a group of participants’ health outcome is assessed based on a research plan. They are not assigned any specific medication or device interventions. For example, a group of individuals can be observed to learn how lifestyles affect different health conditions.

Across the two clinical trial categories, there are several different types of trials. We have listed a few below:

  • Treatment – Involves an investigational medication, device, psychotherapy, surgical, or radiological technique.
  • Prevention– Vaccines, vitamins, minerals, and lifestyle changes that will prevent a condition from returning or developing.
  • Screening/Diagnostic– Looks at more efficient ways to identify a condition.
  • Quality of Life– These look into ways of improving the quality of life for those with chronic illnesses.
  • Genetic– Helps understand how genes and conditions are related, then deciding how likely someone is to get a condition based on genetic makeup.
  • Epidemiological– Where groups of participants are studied to identify patterns, causes, and control of conditions within those groups.

Clinical Trial Phases

Before an investigational drug or device can go through a clinical trial, it has to show promise of being a more effective treatment option. From there, clinical trials go through four different phases.

  • Phase I: This the first time an investigational medication or device is tested in people, so the treatment group will be small. This phase helps identify a safe dosage range, side effects, as well as safety and effectiveness. This phase often includes overnight stays during the dosing to ensure around the clock monitoring.
  • Phase II: The group size is increased, still evaluating the safety and effectiveness of the investigational treatment.
  • Phase III: Done with larger groups. The investigational treatment will be compared to other current alternatives. Safety, effectiveness, and side effects will continue to be monitored.
  • Phase IV: These are conducted after the investigational treatment is approved by the FDA. They continue to provide information on safety, effectiveness, and best use practices.

If you or someone you know is interested in participating in clinical research, we are seeking participants for a variety of conditions. Qualified candidates who participate may receive study-related care at no cost and compensation for time and travel. To learn more about these studies and to explore our other research opportunities, click HERE.

References:

https://www.fda.gov/patients/clinical-trials-what-patients-need-know/what-are-different-types-clinical-research

https://www.clinicaltrials.gov/ct2/about-studies/learn