Concomitant Medications and the Rest of Their Care

Part of Sub-Investigator (SUBI) Training: Working With the Site Team.

About 2 minutes. Free, in your language, no account needed.

Participants have lives and other doctors

They see a general practitioner, get prescriptions elsewhere, buy things over the counter and take supplements.

Most of that never reaches the trial record unless somebody asks properly.

Ask in a way that finds things

"Any new medicines?" misses a lot. It misses supplements. It misses herbal products. It misses painkillers bought over the counter, and anything a specialist started.

Ask about each category, and ask about stops as well as starts.

Prohibited medications need checking, not remembering

Protocols list prohibited and restricted medications. The list is longer than anybody recalls.

Check it when something new appears, especially where interactions with the study intervention are plausible.

A prohibited medication already taken is reported, not hidden

It is a deviation, and it may affect whether that participant's data can be used for some analyses.

Reported, the sponsor can assess it. Unreported, it is a confounder nobody knows about.

Tell the other clinicians

The participant's other doctors need to know they are in a trial. They may prescribe something prohibited. They may need to know about the intervention in an emergency.

A study card, a letter to the general practitioner, and a note in the shared record.

Changes are dated

Start and stop dates matter for attribution. "On ibuprofen" with no dates proves nothing either way about timing.

Care outside the study is still their care

Being in a trial does not pause everything else. Participants get other illnesses. They need other treatment. The protocol is not a reason to withhold it.

Where treatment conflicts with the protocol, that is a discussion, and the patient comes first.