About Our Clinical Studies Center:

Minnesota Clinical Study Center (MCSC) is an independent, privately owned clinical trials research center devoted to conducting clinical trials for hair, nail, and skin medications.  Board Certified Dermatologists evaluate and care for our research subjects.  Steven Kempers, M.D. is our Research Director and devotes 4 days a week to seeing our research participants.  Minnesota Clinical Study Center is located in Anoka County, one of the fastest growing counties north of Minneapolis, Minnesota.  MCSC has been conducting clinical trials for over 20 years. 

If you are interested in participating in one of our clinical trials as a research participant, please review the Information for Clinical Trial Participants section.  We are continually starting new and exciting trials that offer new treatments and promising drugs long before they are available to the public.  To see a current listing of clinical trials click here to be taken to our Current Research Studies page.  Please check back often.

If you are a Pharmaceutical Company looking to place a clinical trial, please review the Information for Sponsors section.

 

 

Information for Trial Participants

What is a clinical trial?

Clinical research trials are used to test and evaluate investigational drugs and treatments.   A new investigational drug or treatment must be shown to be both safe and effective before it can be considered for approval by the U.S. Food and Drug Administration (FDA).  A carefully monitored clinical research trial is the best way to find out if a new treatment is safe, effective, or better than medications that are already available.

    • Phase I trials are the first step in testing a new drug on people. These are small studies where everybody in the study is given the same drug. Phase I trials answer questions about the best way to give the drug and how much of it can be given safely. The study staff watches carefully for harmful side effects and other possible risks. 

    • Phase II trials are larger studies that continue to test the safety of the new drug. Phase II trials also begin to test how well the new drug works by comparing the new test drug with the standard treatment. In some cases, such as when there is no effective treatment for a condition, the new drug is compared to a placebo, that is, a treatment with no active ingredient. A placebo is sometimes called a "sugar pill."

    • Phase III trials are very large studies that are done if the new drug showed promise in Phase II studies.  Phase III trials compare a new drug with the standard treatment to see which one is more effective. In some cases the new drug is compared to a placebo. Side effects are also studied. Phase III trials are usually randomized. Randomization is a research method that helps prevent the results of a clinical trial from being biased. Participants agree to be randomly selected, that is, assigned by chance, to one group or another in the research study.

    • Phase IV trials may be done after the new drug or treatment is already approved for use by the Food and Drug Administration. These studies continue to test the effects of the drug on different types of people, and to look for long-term side effects.

Who can participate in a clinical trial?

Every clinical trial attempts to answer some very specific research questions.  To do this, each trial has certain requirements about health, age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.  You must meet the requirements of a particular trial to be an eligible volunteer.

 

Information for Sponsors

Minnesota Clinical Study Center is located approximately 35 miles north of the Minneapolis/St. Paul International Airport (see the map for location and directions).  MCSC has a large base of potential trial participants with a wide demographic variety.  Our recruitment strategies include:

 

  • Access to patient subjects through an affiliation with Associated Skin Care Specialists, P.A., one of the largest private dermatology practices in the United States.
  • Active database of previous research participants.
  • Focused advertising to select populations.
  • Consistent media advertisements using radio, newspaper, and flyers.

     

    Completion rates and enrollment for our studies are high and typically meet or exceed sponsor requirements.  We are frequently asked to enroll more than our original quota to help the sponsor reach national goals.

    Our principal investigator, Steven Kempers, M.D. is a board certified dermatologist with a broad range of experience.  Our support staff includes four full-time Research Coordinators, four certified through ACRP, a dedicated research subject recruiter, and a Regulatory Specialist/Supervisor.  We are experienced in Phase II through Phase IV levels.  Our facility has a laboratory for processing lab specimens, and we have a secured, locked storage room for investigational medications and supplies.  Our Research Coordinators are IATA certified to ship diagnostic specimens.

    Our Staff: 

    Principal Investigator:  Steven E. Kempers, M.D.

    Sub-Investigator:  Jane Lindholm, M.D.

    Sub-Investigator:  Erika Rabeni, M.D.

          Sub-Investigator:  Roger Weenig, M.D.

          Regulatory Specialist/Supervisor: Dawn Snow, LPN, CCRC

          Coordinator:  Alissa Prochniak, M.A., CCRC

          Coordinator:  Janet Rachel, RRT, CRC

          Coordinator:  Donna Roberts, R.N., CCRC

          Coordinator:  Barbara Schwandt, CCRC

          Receptionist/Recruiter:  Allison Horita