Frequently Asked Questions About Participating in Research

What is a clinical trial?

A carefully designed, systematic study of the safety and/or effectiveness of new, often innovative, healthcare options. A clinical trial is sometimes called a clinical research study. Clinical research studies often try to determine whether new medicines, procedures, equipment or therapies are safe or will help in treating, diagnosing, preventing or caring for people with specific illnesses or conditions.

Why are clinical trials important?

  • To find new advances in medicine
  • To find new ideas or approaches for treatment
  • To identify safety and effectiveness of treatments
  • To receive FDA approval for use of new drugs or devices
  • To find out which existing treatments might be better for certain patients, which might be the most cost-effective, or which might be easier to give

Why might I want to participate in a clinical trial?

There are many reasons why people participate in clinical trials, but here are a few reasons:

  • To help others
  • To help advance science or knowledge about a particular disease or treatment
  • To possibly improve their own health
  • To benefit from having a research team involved in their care
  • To receive treatment options that might not otherwise have been available to them or a physician outside the research facility

How do I participate in a clinical trial?

Either search trials locally and/or nationally to find a trial (for instance for a specific disease of interest). You should find the appropriate contact info there.

How are clinical trials conducted?

Study Protocol

  • The entire plan of the research study
  • Answers any questions you may have about the study
  • Safeguards medical and mental health of patients

Types of Studies

  • Testing one treatment in a group of patients
  • Testing two or more very similar groups who each receive a different treatment option such as:
    • Treatment of interest
    • Standard treatment for the disease (active control)
    • Inactive substance (placebo control)
    • No treatment at all
  • Randomized
    • Where the patient is assigned to either a treatment or a control group by chance
  • Single-blinded
    • Where the patient(s) are unaware of the treatment they are given, but the researchers know what treatment each patient is being given
  • Double-blinded
    • Where both the patient(s) and researchers are unaware of which treatment they are given

 

What else goes into conducting a clinical trial?

  • Doctor can remove you at any point from the study if the study treatment is not helping the patient
  • The patient can decide to withdraw at anytime
  • If the treatment is harmful or ineffective, or if one treatment is considerably better than the other the study will come to a halt earlier than anticipated
  • Results of a study are generally published in medical journals or on clinicaltrials.gov
  • Throughout the entire study the patient’s personal doctor is kept up to date about their progress in the study

Why are clinical trials divided into phases?

The four phases for clinical trials were designed because each phase has a special purpose in helping scientists answer different questions about the drug or therapy being tested.

 

Phase I

 

  • New treatment given to a small group (20-100)
  • Determine the safety of the drug therapy by:
  • How much is given (dosage)
  • What side effects occurred, if any
  • Volunteers in Phase I trials are generally healthy volunteers
Phase II

 

  • Medium size group (100-300)
  • Determine if the treatment has an effect on a particular disease state
  • Volunteers in a Phase II trial are typically those who have the disease or disorder of interest
  • If the treatment was determined to be effective in Phase II then it will move into Phase III
Phase III

 

  • Larger group (1000-10,000)
  • Compare the treatment with a placebo or with standard treatment(s) to determine which is more effective or if it is equivalent to the existing treatment
  • Phase III trials can last many years and involve thousands of volunteers
  • Once Phase III has been completed, the drug or device company will go to the FDA to request approval to sell the drug or device in the U.S. as a treatment for a particular disease
Phase IV

 

  • In Phase IV, the treatment has already been approved by the FDA and is ready for post-marketing
  • What do they look for during post-marketing?
  • To look at the treatment after it has been given to the general population to assess any side effects and safety issues that may not have been recognized in a Phase III trial
  • Continue to monitor the effects of the drug in a population of 3 million people in a Phase IV trial versus 3,000 people in a Phase III trial
  • Test to see if the drug may be useful to treat other diseases

 

 

 

Other Helpful Resources

  • MedlinePlus is an up-to-date authoritative database of medical information which includes a drug encyclopedia, medical dictionary, health directory, videos and tutorials and much more!
  • INresearch.org

INresearch.org is a registry of volunteers, both healthy and with health conditions, that wish to participate in research studies in Indiana. This registry was created to help Indiana citizens find and participate in health-related research studies of interest to them. The website does this by matching volunteers with researchers throughout the state.