Clinical trialists must make the additional effort to estimate the minimum clinically important treatment effect that is relevant to practicing clinicians.
Such warehousing of clinically important covariates would serve as an important resource, allowing systematic reviewers and clinical trialists to explore nuances in treatment effect that might inform clinical decision making, and allowing for increased applicability of findings.
The basis for this review was discussions between scientists, clinical trialists, and regulatory representatives at the 10th Global CardioVascular Clinical Trialists Forum.
Major journals now require clinical trialists to register studies a priori and follow specific reporting guidelines.
Reputable American clinical trialists have staked their reputations on the validity of the Russian trials.
The participants included regulatory, industry and donor representatives and clinical trialists, epidemiologists and statisticians from both developed and developing countries.
Effectively evaluating disease-modifying effects in clinical trials has posed a problem for clinical trialists and drug development.
Tremendous advances in our understanding of pathogenesis of amyotrophic lateral sclerosis (ALS) have provided a rich pipeline of drugs for clinical trialists.
In response to growing concerns about the quality of clinical trials, a group of 30 experts including medical journal editors, clinical trialists, epidemiologists and methodologists identified 22 items for which there was evidence that inadequate reporting can introduce bias.
While no design achieves the perfect balance of sensitivity and efficiency, clinical trialists continue to work toward the goals of smaller and shorter trials so that more compounds can be studied concurrently.
As a result, clinical trialists are challenged to design studies that reflect these determinants of outcome, to optimize the patient's eventual clinical course both in the trial and in actual practice.
