How can I make sure to receive study drug in a research trial and why does the study have placebos?

Medication Trial

Most Clinical Trials are “double blind”meaning that neither the patient nor the medical team know what medication or dose they are receiving until the study is over. Occasionally studies are “open label” where everyone knows what treatment the patient is getting. Less frequently studies can be single ” single blind” where one of the parties is aware of the treatment and the other is not.

In addition most trials involve a placebo which is a tablet that looks like the test medication but has no active ingredients. These trials compare the safety and efficacy of a new medication to a placebo or no treatment. This  can pose an ethical dilemma when a trial is evaluating a medical condition that has good medical options, hence participating in a trial may result in the individual not being treated for their medical issue

Occasionally trials use a comparator drug or different doses of the study drug  however the most effective way to test the efficacy and safety of a product is in a placebo controlled  double blind trial which  is ” the gold standard” .

I tell my patients that enrolling in a trial is important to help bring new safe treatment options to the market and does not always benefit those participating. Communication between the study team and study participant is crucial for a study to be successful.

-Dr. Howard Schwartz M.D. – Gastroenterologist

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Is it safe to participate in a clinical trial?  

Clinical Study

In general all research studies are designed to minimize the risk to the volunteers participating in the clinical trial. Most drug studies start evaluating the safety of the drug at the lowest dose and only move onto higher doses once a lower dose is found to be safe. During the trial, medical exams, office visits, laboratory and diagnostic test are unitized to monitor individuals safety and wellbeing while they are in a clinical trial.

It is important that you see your study doctor at every trial visit and let them know if you are experiencing any side effects from the investigational treatment. In my opinion, there are risks to any new treatment; however, if you have an informed volunteer with an experienced physician and a trial team, the study process works and the benefits out way the risks for most study participants.

Remember, as a study participant you can withdrawal or discontinue your study participation at any time for any reason without penalty or prejudice.

Thank you for following this series of articles. My goal is for you to be informed and have more knowledge about clinical trials. Don’t miss next week topic on study drug versus placebo.

 

-Dr. Howard Schwartz M.D. – Gastroenterologist

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What is an Informed Consent?

Informed Consent

So, suppose you want to participate in a clinical trial. When you inquire for more information and decide to come in for a screen visit you will be asked to sign what is called an Informed Consent. But, what exactly is this piece of document?

An informed consent for a clinical trial is a document that explains the risks and benefits to a volunteer about participating in a clinical trial. It is important to read and understand the consent and have time to ask any questions prior to signing the document. The informed consent should be looked as a process where the participant should interact with the investigator and his delegates so all parties understand their responsibilities and rights.

This document is developed by the research institute following FDA guidelines and is reviewed and approved by the Institutional Review Board prior to the start of the subject recruitment process and modified if additional risks or adverse effects are added to the tested product. However, even if you initially sign this document you always have the chance to withdraw from the study at any given time for any reason.

 

The FDA guidance lists the elements that should be included in the consent and they include:

  1. A statement explaining that the study involves research and what the purpose of the trial is.
  2. It should list what occurs at each study visit and if any experimental procedures is involved.
  3. Description of any potential risks from participating in the study.
  4. Description of potential benefits to study participants as well and to individuals with similar medical issues not participating in the study.
  5. Disclosure of other potential alternative treatments to participating in the study.
  6. Statement about volunteers information and records will be kept confidential and the FDA can inspect the records
  7. Statement about whether compensation is available if an injury occurs to someone participating in a trial and what process to follow if a medical injury or side effect occurs.
  8. A statement describing who to contact for study related questions and who to contact in case of injury.
  9. A statement that research is voluntary and that an individual can discontinue their participation for any reason at anytime without a penalty.
  10. A statement that research may contain unforeseen risks to both, the participant and potentially to an unborn fetus.
  11. Circumstances by which a participant can be discontinued from a study without their consent.
  12. Any potential costs from participating in a study.
  13. Statement that any knew information that is learned will be disclosed to participants.
  14. Number of participants in the study.

 

There are many people that are skeptical about participating in clinical trials because of safety reasons. It is important to remember that the main concern for any study site is to keep subject safe at all times. In my next blog I will discuss more about your safety during these types of studies. Stay tune for more!

-Dr. Howard Schwartz M.D. – Gastroenterologist

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What is a drug study or clinical trial?

Clinical Trial 2

When you hear radio or TV commercials promoting studies to test new drugs or products, have you ever wonder what do these studies exactly consist of? A clinical trial is the process by which a new drug or medical treatment is tested for safety and efficacy. Generally, trials are divided into Phase 1, 2, 3 and 4.

Phase 1 trials are conducted on healthy individuals and look primarily at safety and how the drug is metabolized in the body. Phase 2 trials are conducted in a small group of individuals and are used both, to learn more about safety and proof of concept and to see if the treatment works in subjects usually with a certain medical condition. Phase 3 trials are larger studies where medications are given to an increased number of individuals typically with a medical condition and typically are used by the FDA to decide on whether to approve a drug or not. Finally, Phase 4 trials are typically used to collect data after a drug is approved and used to answer some safety or efficacy questions at time of the drug approval.

When you inquire about any study that you would like to participate, all the study details will be given to you so you can make an educated decision whether to you want to get enrolled or not. This is usually called Informed Consent, which will be explained in my article for next week. Stay tuned!

-Dr. Howard Schwartz M.D. – Gastroenterologist

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