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Clinical Trials - FAQs


I’m interested in a particular trial – when can I start?

Although it’s wonderful that you are interested in participating in a clinical trial, your interest alone is not enough. There are inclusion and exclusion criteria that prospective participants must meet in order to join a particular study – these may include a specific age group, stage of disease, years since diagnosis or whether you are on medications and if so, what type among many others. Whether or not you qualify may be explored through a phone interview, following an in-person assessment or after initial testing. But don’t be discouraged if you don’t qualify. There are likely a number of other clinical trials that are a good fit.


Is joining a clinical trial safe?

All clinical trials are designed to follow a strict protocol that is subject to federal regulations and are scrutinized to make sure that the safety and rights of participants are protected. Prior to beginning any study, the risks, potential benefits and alternatives must be reviewed in enough detail with you that you are able to give what is called “informed consent”. By giving consent you are agreeing to participate with the suggested protocol but you may withdraw at any time if necessary.


What questions should I ask?

As part of the informed consent process there are a number of pieces of information you may wish to have. For example:

- What intervention are they testing in the trial and how do they determine who will receive it?

- What are the chances you will receive a placebo?

- What are the risks and benefits believed to be of the intervention compared to the treatment you are already receiving?

- What tests and / or procedures will you have to do?

- What are the potential discomforts?

- What are my rights as a participant in the study?

There are also a number of logistical issues that need to be sorted out.

- How long is the study?

- How many visits will you have to make?

- Is their any compensation? Will my expenses be covered?

- Who do I call if I have any questions or concerns?

Only once you are satisfied that your concerns have been addressed to your full satisfaction, should you give informed consent to participate.


Can I stop a clinical trial once I start?

Although it is obviously ideal for all participants to complete the trials they begin, you may stop taking part at any time. There are many life circumstances that can arise – occupational or family issues, changes in your health status and so forth that may require you to withdraw. Things can change which is completely understandable.


What are my rights as a trial participant?

You have the right to not take part in a research study or drop out at any time. You have the right to know about any change in protocol or new information that may pertain to the study. You have the right to ask questions and should receive answers to you satisfaction in a timely manner.


Will I get paid for participating in a clinical trial?

Every trial and research group has a different policy when it comes to compensating participants. Most will reimburse you for any costs related to the trial itself such as transportation to and from their center. Some will provide a small additional stipend. You can find out this information from the trial coordinator directly.


Do I still see my own doctor?

Although you may see a physician that is part of the research trial in which you are enrolled, you will still need to follow up with your regular doctor for your ongoing care. It is important to advise your own doctor of your involvement in a study in case they need to communicate with the researcher regarding any change in management or medications.


What happens once this trial ends?

Following completion of the trial, the investigators will gather, analyze and document their findings and will usually submit the results for publication. They may also choose to convey the findings to those that participated in the study or you may have to pursue the results yourself. If the intervention is successful then it may be further evaluated in the next phase of study for which you may qualify .


If you found benefit from the intervention you received, it is unlikely you will be able to continue with it outside of the clinical trial (there may be a few exceptions but they are uncommon). That having been said, the trial itself may lead to the medication or procedure being available to the patient community once it passes further rigorous evaluation and approval for general use.


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Dr. Soania Mathur

Instagram: Unshakeable_MD 

Twitter: @SoaniaMathur

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soaniamathur@unshakeablemd.com

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