Third, evidence from the first analysis of the ATAC (Arimidex, Tamoxifen Alone or in Combination Trialists Group) trial supports the use of aromatase inhibitors such as anastrozole for the adjuvant treatment of early breast cancer in postmenopausal women (Baum et al, 2002).
These data and the analyses by Matikainen et al. (20) and the Cholesterol Treatment Trialists' Collaborators (21) strongly support aggressive lowering of LDL-C in individuals with diabetes.
Supported by the COST funding, aphasia trialists from multidisciplinary backgrounds have created a forum to share knowledge, resources, support consensus generating activities, foster early-stage researchers, disseminate new research developments and plan coordinated transnational programmes of aphasia research.
A recent joint statement of trialists and scientific associations further supports this point of view (12).
The use of organ failure free days to determine patient-related morbidity surrogate end-points in paediatric trials has been supported by influential paediatric trialists in the current low mortality paediatric critical care environment[ 52].
With provisional enthusiasm expressed by NIDDK and financial support from the American Diabetes Association, clinical trialists D.M.N., J.B.B., Hertzel C. Gerstein, Rury R. Holman, Richard Kahn, S.E.K., J.M.L., and Bernard Zinman designed a preliminary proposal in early 2009.
Also, trialists may not consider if the outcome supports what the trial aims to clarify and may therefore, inappropriately, choose a surrogate as a result of lack of guidance on trial design.
The problems related to placebo treatment are supported by thorough criticism of trialists and sponsoring companies performing placebo-controlled trials in the prophylaxis of postoperative nausea and vomiting [ 13, 14] – trials that all provided sufficient antiemetic rescue medications for all participants!
However, researchers also need some scope for flexibility and contingency in planning PPI: our finding that some trialists expanded their sometimes already detailed plans supports the need for flexible and iterative approaches to PPI in order to accommodate the unexpected and respond to opportunities and difficulties as they arise.
