Stephanie Chan wrote:
> I am preparing a talk on the pitfalls of early trial termination for my
> housestaff this week. Can you think of an example of a recent trial
> that was terminated early, inappropriately?
I have a page on early stopping of clinical trials
* http://www.pmean.com/category/EarlyStopping.html
and the list of outside resources on this page has a few articles that
you might find helpful.
Premature discontinuation of clinical trial for reasons not related to
efficacy, safety, or feasibility Commentary: Early discontinuation
violates Helsinki principles. Lievre M, Menard J, Bruckert E, Cogneau J,
Delahaye F, Giral P, Leitersdorf E, Luc G, Masana L, Moulin P, Passa P,
Pouchain D, Siest G, Boyd K. BMJ 2001: 322(7286); 603-606.
Selegiline, or the problem of early termination of clinical trials. The
clinical questions are not well answered, and probably never will be.
Breteler MM. British Medical Journal 1998: 316(7139); 1182-3.
Tamoxifen for the prevention of breast cancer. Important questions
remain unanswered, and existing trials should continue. Bruzzi P.
British Medical Journal 1998: 316(7139); 1181-2.
The Ethics of Early Stopping Rules: Who Is Protecting Whom? Cannistra
SA. Journal of Clinical Oncology 2004: 22(9); 1542-1545.
You might also find this case study interesting:
* http://ethics.ucsd.edu/workshops/CRW/cases/case2.htm
Also note as a counterpoint
Safeguarding patients in clinical trials with high mortality rates.
Freeman BD, Danner RL, Banks SM, Natanson C. Am J Respir Crit Care Med
2001: 164(2); 190-192.
which argues that several trials were not stopped early enough.
I try to include links to the full free text of articles when it was
available, but my page on early stopping needs a bit of updating.
--
Steve Simon, Standard Disclaimer
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