Clinical Trials Discussion Guide

The COVID-19 pandemic may bring uncertainty and confusion about your participation in a clinical trial. Whether you are currently enrolled or newly enrolled, there may be possible changes to your study and how you are monitored. Research staff and personnel aim to update participants regularly, but you may have questions in the interim.

To help guide these conversations, we've outlined some questions below that may be helpful for you to ask your doctor and research coordinator. Remember: if you have any concerns about your safety with these trials, please discuss this with your research team.

Click the topic areas to see a list of questions you can discuss with your doctor.

Procedures/tests/blood work

Should I expect procedures for the trial to be postponed or rescheduled?
How will my scheduled procedures proceed during the pandemic? Will the study allow them to be postponed while allowing me to remain a participant?
I’ve finally found a trial and have gotten my hopes up for treatment. Will the trial still occur after this?
What precautions should I take in order to be able to complete these procedures/tests/blood work and keep myself safe?
Will I still be required to get blood work during the pandemic?
What should I do if I feel unsafe going to a drawing lab (Quest, LabCorp) for routine or scheduled blood work?
What is the plan of care if I am due for an endoscopy per my trial protocol during this time?

Attending clinic visits

With shelter in place orders in many states, can I still go to my scheduled clinic visit?
If I begin to feel symptoms, should I risk exposure to COVID-19 to go into my physician’s office, or should I request a telehealth visit?
How can I reach my doctor (clinical trial investigator) during this time and/or the person in charge of the specific trial?
Will the number of clinic visits decrease?
Is it safe to attend a clinic visit in person?
Will my clinic visits become virtual visits instead of in person visits?
If a clinic visit needs to occur, will the time the visit takes decrease? E.g. if there is an observation period after receiving medication, will that time be eliminated/decrease/stay the same?
How are office staff staying protected when interacting with patients?
Will clinic visits still be required on the same timeline?

Withdrawing from a trial

Will the trial continue, or will I be forced to withdraw?
Do I need to feel guilty or like a failure if I withdraw from the trial?
Am I ever stuck in a trial? Even after signing the waivers?
Will I be able to withdraw from one study and join another study immediately if that study is continuing?
Should I withdraw from the trial since I can’t physically attend visits?
If I decide to withdraw from the trial because I am uncomfortable participating due to the pandemic, how does this impact the study?
What are my options for treatment should I decide to withdraw?
If accommodations can’t be made, can I re-enroll in the study when this pandemic is over?
Should I withdraw from the trial if it could increase my risk for COVID-19 or other serious symptoms?

Obtaining study medication

Is it safe to have study medication administered in a clinic?
How do I now get my study medication?
If the study is put on hold for any reason, will I need to come into the office prior to changing medications?
Will I still need to come in to receive the study medication, or are there alternative ways to receive the medication?
Depending on the type of medication I am taking, will the process for receiving mediation change? E.g. if I am receiving IV medication, will a home nurse provide it at my home? Will I go to a different clinic to receive the medication? If it is subcutaneous, will I learn how to self-inject instead of going into a clinic?
Can I get my medications delivered, so that I can remain safe at home?
Will there be a way to have contactless medication pickup?
If the study is put on hold for any reason, would I be able to change medications during this period and re-enter the trial at a later date?
Will you tell patients if the medication they are on (or placebo) lowers the immune system?

Clinical trial patient experiencing COVID-19 symptoms

Will I know the difference between COVID-19 GI symptoms and IBD symptoms?
What should I do if I begin feeling symptoms of COVID-19 while enrolled in the trial?
Who should I contact if I start experiencing COVID-19 symptoms while I’m in the trial?
What should I do if I have symptoms of COVID-19?
If I feel like I have symptoms, do I automatically have to withdraw, no matter how far along I am? Is my trial on hold until the pandemic passes?
If I test positive for COVID-19, will I have to withdraw from the trial?
Does having symptoms of COVID-19 mean I need to withdraw from the trial?
Does contracting COVID-19 disqualify me for the study?
Should I remain home if I believe I am developing COVID-19 symptoms, and will the study site test me for COVID-19?
Should I report taking any additional medications to relieve symptoms of COVID-19? E.g. acetaminophen, and other cold and flu medications (prescribed or over the counter)?

Completing in-person surveys

Can I still be in the trial if I do not want to do any surveys and/or visits in person?
How often would I be expected to take a survey?
Can I complete the surveys for the trial online or during a virtual visit?
Will there be a way to do the surveys over the phone?
Can surveys be moved to a video call?

Safety and Risks

What kind of additional safety measures are being put in place to protect me if I come in for a visit? Is the site implementing additional screening measures such as taking temperatures or limiting the number of people coming in for visits?

Last updated 4/29/20