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823 S.W. Mulvane Suite 240
Topeka, KS 66606

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(785) 270-8619

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 Health 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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