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Are You Involved in a Clinical Study? Here’s How to Take Your Medications Safely

Rivka Siden and Kim Redic

Medications used in clinical studies include both medications that have not yet been approved by the U.S. Food and Drug Administration (FDA) as well as FDA-approved medications that are being tested for safety and effectiveness to treat new or different health conditions.

If you are participating in a clinical study and are taking a study medication, here is some important information on how to safely take, handle, and store it:

What do I need to know about being in a clinical study?

  • Your study medication may be available to patients with other diseases and information on its use may be available in ads and on websites. However, because you are taking this medication as part of your participation in a clinical study, you must follow the instructions that the study team gave you.
  • Some clinical studies use a "control group" to determine if the investigational treatment is effective. In these studies, you may be randomly assigned to receive the standard treatment or a placebo instead of the investigational medication.
  • A placebo is an inactive tablet, capsule, or other treatment. In clinical studies with control groups or placebos, you and your doctor may not know which medication you are taking. Even if you may be taking placebo, it is important to take your study medication exactly as directed.
  • More information about your study medication and how to contact the study team is included in the "Informed Consent" document you signed at the beginning of the clinical study.

How should I take the study medication?

  • Take your study medication exactly as instructed. This will ensure your safety while also allowing the study team to receive accurate information from your participation.
  • If you are taking medications orally, it's important that you swallow each tablet or capsule whole. Do not chew, crush, or open the medication unless the study team tells you that you can do that. If you cannot swallow the study medication, contact your study team to ask about other approved ways to take it.
  • If you miss a dose or vomit up a dose, check the instructions that the study team gave you or contact the study team as soon as you can to find out what you should do.
  • Some medications may require special handling. Check with the study team for information on how to handle your medication, including whether you should use gloves and what to do if there are spills or accidental contact.
  • Be sure to bring all bottle(s) or container(s) (including empty containers) to each clinic visit or if you are admitted to the hospital. Do not dispose of any study medication yourself.
  • If you receive a drug diary or a study log, fill it out completely and accurately. In the drug diary, be sure to list any doses that you missed or vomited and any side effects that you felt.
  • Include your study medication in the list of medications you take. Tell your pharmacist and primary care doctor about your study medication so that they will have an accurate list of all your medications.

How should I store the study medication?

  • Keep the study medication in the original container. Do not transfer the medication to another container or to a medication box.
  • Store your medication in a safe place, away from other family medications or food, and out of the reach of children and pets.
  • Check the medication label to see if you need to store it in a specific place like the refrigerator or if you need to protect it from light. If your medication needs to be stored in the refrigerator, use a zip-top bag to keep it away from food. If the medication needs to be protected from light, place it in a brown paper bag
  • If your medication must be stored at room temperature, store it away from excessive heat and moisture and out of direct sunlight. Do not store your medication in the bathroom. 
  • When you travel, do not store the medication in the car to avoid exposure to extreme temperatures. When you fly, take the medication in your carry-on luggage to ensure that the temperature is controlled and to avoid losing the medication.

When do I need to contact the study team?

  • Before starting a new medication (including over-the-counter medications and herbal supplements),
  • If you feel that you are having side effects from taking the study medication,
  • If you have any questions or concerns about the study or study medication, or
  • If you are not sure how to take the study medication.

Where can I find more information on clinical studies or study medications?

By Rivka Siden, M.S., Pharm.D., Clinical Pharmacy Specialist, and Kim Redic, Pharm.D., BCPS, Manager, University of Michigan Health-System Research Pharmacy, Ann Arbor, MI