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Home > Our Research > FAQs

Research FAQs

Please review our list of frequently asked questions (FAQs) below to learn more about medical research. If you have questions that are not addressed in the FAQs, please contact one of the following persons.

To learn more about studies that are open for enrollment, please review the relevant research area on our website to see if any volunteers are needed. If you would like additional information on how to enroll for a study, contact:

Carla Erickson, RN, MS, CCRP
Director, Clinical Trials Training
612 873 6341
cerickson@mmrf.org

For current, prospective, or past research participants to discuss problems, concerns, or questions; obtain information; or offer input with an individual who was unaffiliated with the specific research protocol, please contact:

Frederick Langendorf, MD
Chair
612 873 6882
lange002@umn.edu

Karen Heim-Duthoy, PharmD
Vice Chair
612 873 6880
heimd001@umn.edu

Cindy Hanson
IRB Coordinator
612 873 6881
chanson@mmrf.org

Carla Erickson, RN, MS, CCRP
Director, Clinical Trials Training
612 873 6341
cerickson@mmrf.org

 

FAQs

What is clinical research?

What are clinical trials?

Why are clinical trials done?

What is the difference between a clinical trial and standard medical care?

What are the phases of clinical trials that use investigational drugs?

Why volunteer for a clinical trial?

Are clinical trials safe?

Are clinical trials overseen by a regulatory board?

What is a protocol?

What is informed consent?

Who may participate in a clinical trial?

What should you ask before entering a clinical trial?

What factors should you consider before entering a clinical trial?

Whom may I contact with further questions?

 

What is clinical research?
Research is a methodical investigation into a subject. Clinical research is carried out to obtain new knowledge of a disease or condition and to add to already known facts. New or improved medical treatments are often the result of clinical research. 

 

What are clinical trials?
A single clinical research study is called a clinical trial. Clinical trials are done with human volunteers. Clinical trials attempt to answer specific health questions.

There are different types of clinical trials. A clinical trial may study::

 

Why are clinical trials done?
It is not really known whether a new treatment or intervention offers any benefits to humans until the clinical research is complete. Federal law states that clinical trials must be conducted before a new drug or treatment may be marketed in the United States. 

 

What is the difference between a clinical trial and standard medical care?
Clinical trials are not the same as standard medical care. Standard medical care is the customary approach currently used in caring for the health of individuals. Clinical trials are research studies looking at potential new or improved treatments and interventions before they are marketed. 

 

What are the phases of clinical trials that use investigational drugs?
Each phase of a clinical trial has a different purpose.

Phase 1: Phase I trials initiate the introduction of a new drug in humans. Phase I trials usually involve 20-80 individuals and are closely monitored by the investigator and sponsor. These trials are designed to determine the safety of the investigational drug.  Side effects associated with increasing doses and the safe dosage range are studied. How the drug is absorbed, metabolized, and its mechanism of action in humans is also determined during a Phase I trial.

Phase II: Phase II trials begin the evaluation of a drug’s effectiveness for a particular condition or disease. Common short-term side effects and risks associated with the new drug are determined. Approximately 100-300 patients with the specific disease condition are enrolled into Phase II trials.

Phase III: Phase III trials are carried out after preliminary evidence from Phase I and Phase II trials suggests that the new drug is safe and effective. Phase III trials usually include several thousand individuals. Most Phase III trials are randomized and blinded. This means that the standard medical care for a disease (or placebo if appropriate) is compared to the study drug.  Often neither the subject nor the study investigator knows what the subject has received until the trial is completed. Phase III trials allow a more complete understanding of the drug’s effectiveness, benefits, and associated adverse reactions.

Post-Marketing – Phase IV: These trials may be carried out to monitor a drug’s long-term effectiveness and long-term side effects. The cost-effectiveness of the new drug therapy compared to other traditional therapies may also be studied.

 

Why volunteer for a clinical trial?
By taking part in a clinical trial, an individual can try a new treatment that may be better than those that already exist. Individuals can also help researchers better understand how the treatment works in diverse populations.

 

Are clinical trials safe?
Treatments used in a clinical trial have first been studied in laboratories and animal experiments.  Treatments that have acceptable safety reports and show the most promise are then moved into clinical trials. 

An individual must qualify for a clinical trial.  Inclusion and exclusion criteria (requirements such as age, previous medical history and type of disease) are used to determine whether a person may or may not be allowed to enter a clinical trial. An individual will be allowed to participate in the clinical trial if all inclusion criteria are satisfied. If an individual meets any of the exclusion criteria participation will not be allowed. Inclusion and exclusion criteria help identify appropriate participants and help to exclude those who may be put at risk by participating in a particular clinical trial. If an individual does not meet eligibility requirements for one trial that does not mean she or he cannot possibly participate in a different trial.   

Efforts are made to control risks to clinical trial participants. Some risk may be unavoidable because of the uncertainty fundamental to clinical research that uses new medical treatments or products. It is important that people make their decision to participate only after they have a full understanding of the entire process and the risks that may be involved.

 

Are clinical trials overseen by a regulatory board?
Clinical trial procedures are reviewed by Institutional Review Boards (IRBs). These boards are composed of at least five individuals that include scientists, doctors, nurses, pharmacists, and lay people. Every clinical trial that takes place must be approved by an IRB. The IRB reviews the clinical trial to ensure that appropriate steps are taken to protect the rights and welfare of the participants. If the risks to the participants are found to be too great the IRB will not approve the research or it will specify changes that must be made before the research can be done.

The IRB requires any new information about the clinical trial to be sent to it for review. If new information changes the risks to the participants the IRB may stop the clinical trial or require changes by the investigator to decrease the increased risk. In addition, at a minimum of every year an IRB requires the investigator to submit a summary of how the clinical trial is proceeding.  The IRB examines the summary and then decides if the clinical trial may continue to be conducted.

 

What is a protocol?
A protocol outlines exactly what is going to take place during a clinical trial. The protocol describes what is being studied and why it is an important question, how the research team will protect the health and safety of the participants, what procedures are planned and when they will be performed, possible risks and benefits to the participant, and how the data will be analyzed.

 

What is informed consent?
Potential participants in a clinical trial must be given complete information about the clinical trial before study procedures begin. The informed consent process provides an opportunity for the researcher and potential participant to exchange information and ask questions. Information that must be talked about with a potential participant is:

Individuals invited to enter a clinical trial are not obligated to participate. If an individual does enter a clinical trial the consent form must be signed by the participant before enrollment into the trial and before any study procedures can be performed. The signed informed consent means that the participant has had the opportunity to talk with the clinical research staff and has agreed to participate in the trial.

Trial participants have the right to leave a trial at any time. Participants also need to know that circumstances may arise under which their participation in a trial may be ended by the researcher without their consent.

 

Who may participate in a clinical trial?
Some clinical trials involve people with a particular illness or condition to be studied while other clinical trials ask for healthy volunteers. Each clinical trial has specific criteria that must be met before an individual may enter a clinical trial. Requirements as to age, gender, previous medical history, and other medical conditions are always outlined. In addition other inclusion and exclusion criteria are used to further refine who may enter into a clinical trial.

Volunteering for a clinical trial is no guarantee of acceptance into the trial. There is also no guarantee that a participant in a clinical trial will receive the treatment being studied unless specifically told that it actually is the treatment being studied.

 

What should you ask before entering a clinical trial?

 

What factors should you consider before entering a clinical trial?