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Topeka, Kan. 66606

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Clinical Research Center Clinical Research Q&A

What is clinical research?

The Phases of Clinical Research:

  • Pre-clinical – Animal and laboratory testing 
    Investigational New Drug (IND) - Required application from a pharmaceutical company to the FDA to begin a clinical research study with a new product.
  • Phase I – Researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
  • Phase II – The experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
  • Phase III – The experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
  • Phase III - Further expands group of people to include drug to disease interactions and drug-to-drug interactions.
  • New Drug Application (NDA) – Application to the FDA for marketing approval or license. This occurs after completion of Phase I, II, III to market the drug for specified indication.
  • Phase IV – Post marketing studies to delineate additional information including drug’s risk, benefits, and optimal use.

*Source: National Institute of Health 

What are the different types of clinical studies?

Treatment trials – test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

Prevention trials – look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.

Diagnostic trials – are conducted to find better tests or procedures for diagnosing a particular disease or condition.

Screening trials – test the best way to detect certain diseases or health conditions.

Quality of Life trials (or Supportive Care trials) – explore ways to improve comfort and the quality of life for individuals with a chronic illness.

*Source: National Institute of Health

How are study participants protected?

The Stormont-Vail HealthCare Human Research Protections Program serves to protect the rights and welfare of human research participants in accordance with:

  • Clinical Research and the Protection of Human Research Participants
  • U.S. Department of Health & Human Services
  • The Common Rule
  • Food & Drug Administration
  • Code of Federal Regulations
  • International Code of Harmonization
  • Stormont-Vail HealthCare Institutional Review Board
  • Centrally affiliated Institutional Review Boards
  • Health Insurance Portability and Accountability Act (HIPAA)
  • Joint Commission
  • State of Kansas Laws

For additional information, please call: (785) 270-8619.

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