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The decision to stop enrollment of new patients in the trial followed a favorable recommendation by an independent data and safety monitoring board that found positive results based on 1,520 patients.
Any deficiencies identified were immediately corrected, with an option to stop enrollment until major deficiencies were corrected.
Nonetheless, the incidence was noticeably lower than expected when designing the trial, leading the study team to stop enrollment in Nigeria and to expand the trial to South Africa, a country with a much higher background HIV incidence.
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Lilly, based in Indianapolis, said results were so encouraging, it had stopped enrollment in the Phase 3 trials.
In March, Osiris stopped enrollment in a trial testing Prochymal as a treatment for Crohn's disease, saying it was unlikely the drug would be better than a placebo, because of a high positive response to the placebo.
There would be subsidies for those who have financial difficulty getting private coverage we could pay for it by redirecting regular tax expenditures, gaining administrative savings through one-stop enrollment for clients, electronic transfers of medical records and improvements in the health care information technology spectrum, and ending unneeded hospital emergency room visits.
Nor will PASSport serve as a one-stop enrollment system for parents confused by the plethora of class and school choices, application forms and application deadlines.
We stopped enrollment after patient 34, however, because there had been no dropouts.
A total of 104 patients were randomized to the efavirenz arm, and 64 were randomized to the nevirapine arm (the Data Safety Monitoring Board stopped enrollment of patients into the nevirapine arm after the first interim analysis but allowed enrollment to continue in the efavirenz arm).
Data for 69,274 randomly assigned infants were available in the REST clinical database at the time the Data and Safety Monitoring Board determined that the study had satisfied its criterion for stopping enrollment associated with the primary safety endpoint assessing the risk of intussception among vaccine recipients.
In January 2003, VHA established a policy to stop enrolling Priority Group 7 veterans after January 16, 2003 due to the increase in enrollment and lack of resources.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com