Drug Treatment Studies – Washout Period
What is a Washout?
When a subject is asked to stop taking some or all medications prior to beginning a drug treatment study, this is called a drug washout.
Safety of Washout Studies
- Washouts are appropriate depending upon the disease to be studied and the nature of the proposed protocol.
- Washout studies require balancing the likelihood of harm, the effectiveness of monitoring, and the potential severity of the risk(s) to be avoided.
- When subjects are being washed out from a FDA approved and indicated drug, the individual investigator should clearly define the nature and degree of risk to the subjects and include risk management procedures in the research plan.
- The following issues should be clearly addressed by the investigator and determined to be appropriate by the IRB before the IRB should consider approval of the study:
- when a subject would be withdrawn from the study,
- the frequency of monitoring,
- whether monitoring is in person or by telephone,
- the criteria for managing a subject in the event of worsening, and
- how 24 hour-per-day, 7 day-per-week, medical care is made available in the event of questions, emergencies, worsening, or withdrawal from the protocol.
- To the extent that the investigator demonstrates that the subjects' safety is monitored at all times and provisions are made for immediate rescue if needed, the IRB will consider approval of the study.
- Once an approval is granted, the investigator is bound to follow the risk management procedures as with any other provision of the approved protocol. The risk management procedures should be in the written protocol, with the same level of detail as in the protocol itself.