In fact, a higher percentage of black patients discontinued from the study compared to white patients due to these other reasons (patient decision, physician decision, sponsor decision, noncompliance, lost to follow-up, and criteria not met).
Of those who discontinued, significantly more white patients discontinued due to psychiatric worsening compared to black patients (P =.002) while significantly more black patients discontinued for "other" reasons (e.g., patient decision, physician decision, sponsor decision, noncompliance, lost to follow-up, and criteria not met, P =.014).
Role of the sponsor: Decisions concerning study design, data collection and analysis, interpretation of the results, the preparation of the manuscript, or the decision to submit the manuscript for publication resided with committees comprising WHI investigators that included NHLBI representatives.
This decrease was due not only to the U.S. EPA's recommendations to eliminate tests or to substitute tests with fewer or no animals but also to sponsors' declining to conduct additional testing recommended by the U.S. EPA and, in a few cases, to sponsors' decisions to drop tests they had originally proposed.
a. Execution is concerned with the practicalities of integration (e.g. does the intervention require new money, a local or national policy sponsor), decisions about the distribution of resources, costs and risks within the organisation, managerial decision-making regarding the adoption of the intervention, and formal and informal mechanisms for its evaluation.
In November 2006, UNICEF sponsored key decision-makers from Ethiopia, Kenya, Uganda, Zambia, Malawi, Mozambique and Madagascar to travel to Gadchiroli District in Maharastra State, western India, where they studied Dr. Abhay Bang's pioneering work on newborn care.
The most common reasons for noneligibility were sponsor decision, age <18 years, CGI-S score >3, or no olanzapine treatment before screening.
Reasons for discontinuation included physician decision 6 (2.1%), protocol violation 4 (1.4%), patient decision 5 (1.7%), AE 4 (1.4%), and sponsor decision 2 (0.7%) (Supplementary Fig. 2).
Reasons for early withdrawal included AE (n = 7), patient decision (n = 17), sponsor decision (n = 8), and loss to follow-up from the pateclizumab cohort (n = 2).
Recruitment was halted prior to completion of the planned accrual target of 228 patients because of sponsor decision to discontinue the program due to change in priorities.
Two further dose levels of losoxantrone without cyclophosphamide, 125 and 150 mg m−2 were studied, but the study was terminated before the MTD was reached because of a sponsor decision.
