Clinical trial unfair termination due to the facility's holiday schedules and unavailabilities without prior information

Question

Hello, I am reaching out to consult about a clinical trial my mother was enrolled in. To abbreviate it, she has been enrolled into the clinical trial program back in August of 2024 and until a week ago, she was going through their screening process to determine the study eligibility. Due to the facility's busy schedules and holidays that the staffs required time off, the screening process was prolonged, and then just a couple days ago, we were told that due to the extended time of the screening process the facilitators determined my mother is no longer eligible to participate in the studies. The administrator, the doctor and we as a family were not informed that they had a required timeline for the screening process to be completed but however the headquarter determined that due to the extended time she is no longer eligible and we were delivered the news 2 days ago. Nothing in the writing stated the determination exams to be done within certain time.

James L. Arrasmith · Answer

It sounds like your mother’s disqualification from the clinical trial was unfair, especially since the delays were caused by the facility’s scheduling issues and holidays, not by her actions. If there was no written timeline provided for completing the screening process, then the decision to remove her from the study may be questionable. The lack of communication about this requirement adds to the frustration, as both your family and the doctor were unaware of any strict deadlines.   
 
One option is to request a formal explanation from the facility or the study’s headquarters. Ask for documentation showing where the time limit for screening is stated and why exceptions were not considered given the circumstances. You can also file a complaint with the Institutional Review Board (IRB) overseeing the trial, as they are responsible for ensuring that studies follow ethical guidelines and treat participants fairly.   
 
If your mother suffered harm or missed out on potential treatment because of this decision, you may want to consider speaking with a legal professional who can advise on possible next steps. Trials must follow clear protocols, and if they failed to do so, there may be grounds to challenge their actions. Keep all written communications and notes from conversations with the study staff, as this documentation could be important moving forward.

Q: Clinical trial unfair termination due to the facility's holiday schedules and unavailabilities without prior information