Clinical Trials and Covid 19
We have stressed that patient participation in a clinical trial is crucial to any trial’s success, but covid-19 is causing significant challenges.
The obvious challenges are:
- stay-at-home recommendations
- travel bans
- hospitals and clinics have restricted hours
- social distancing
Aside from these problems, there are even larger, logistical problems that you, the patient, needs to be aware of so that you can discuss this openly with your clinical trial coordinator.
Here are the 4 questions you should definitely discuss with your study coordinator.
Number 1 – ESSENTIAL VISIT
Clinical trials have a set schedule when participants need to be seen. If your area is under a stay-at-home order, then you and your coordinator should discuss if this is an essential visit or can it be missed?
If it is essential, then you need to be able to get to the research site? Ask your coordinator if the sponsor is offering a car service to shuttle you to and from the research site. Also ask if this fee is pre-paid or do you need to turn in a receipt to be reimbursed.
If your study coordinator has informed you that that your visit is not essential, then you need to discuss what happens if you miss the scheduled appointment.
- Does this jeopardize your study status?
- Does this require that you add more visits to your commitment?
- Does the timeline increase for you?
These are very important to know what is going to be required of you due to a missed visit. Make sure that you verify that any drug administration or survey assessment does not need to be completed if you miss a previously scheduled appointment.
NUMBER 2 – VIRTUAL VISIT
There may be a chance that the coordinator may ask you to complete some of the surveys for the study through a video channel like ZOOM. If you agree, be sure to inquire how secure and private this online visit is so that your privacy is maintained.
The coordinator may want to ship the medicine to you so that you continue on the correct dosing schedule. PLEASE take time to think this through. You should ask questions like these:
- How will it be guaranteed that you receive the drug?
- Do I need to sign for the medicine or can someone in your home sign for it?
- Do you know how to administer the drug correctly?
- If it is an injectable could it be possible to have the drug shipped to and administered by your local doctor or maybe through your local pharmacy.
- Does the medicine need to be refrigerated?
- What if you have young children at home or elderly people, how will you protect them?
It is important that you know what your personal capabilities are.
NUMBER 3 – The Institutional Review Board (IRB)
In our previous video, Clinical Trials 101, we discussed the importance of the IRB and their primary goal of protecting study participants like you. Be up front and ask what has the IRB approved? Before you agree to anything, confirm that the IRB has approved of all these procedures, it is documented, and you receive this new document.
NUMBER 4 – SUSPENSION
If the sponsor of the clinical trial you are currently participating in has suspended, or temporarily stopped the trial, you need to know sure if you will be required to restart from where you stopped OR do any of the procedures or assessments have to be repeated. If so, this will clearly impact you and your family.
I hope this information helps you make an informed decision with regard to your current situation and your continued support in clinical trials. These questions are intended to help you understand your new role and start the conversation with your clinical trial coordinator.