Several critical issues, including scientific rationale, clinical trial design, marker assessment methods, cost and feasibility have to be carefully considered in the validation of biomarkers through clinical research before they can be routinely integrated into clinical practice.
The second 'experiment' has been the use of large-scale biological models such as cancer cell lines to correlate mutations in cancer genes with drug sensitivity, such that one could begin to develop rationale clinical trials to begin to test these hypotheses.
As drug development and technology continues to improve, it will be important to design rationale clinical trials enrolling patient populations that represent the overall population, including racial minorities and the elderly, so that trial results can be appropriately extrapolated.
Further exploration of the molecular pathophysiology to design rationale clinical trials is essential.
The potential for NO to have beneficial effects has provided the rationale for trials of administration of NO donors in various diseases.
This is of significant concern and forms the rationale for trialling a different approach to preventing excessive weight gain in obese women.
The objectives and scientific rationale for the trial(s) will be described, and the status of the trial(s) (present accrual, planned closure date) will also be provided.
The top three motives for recruiting patients were: (1) the attractive scientific rationale of the trial (84%); (2) a design that was easy to explain to patients (79%); and (3) a pragmatic trial design in line with standard practice (76%).
The rationale for the trial stems from a surprising finding from the research team led by Dr. Steven Cummings, assistant dean for clinical research at the University of California, San Francisco.
The rationale for the trial is discussed and the main study outcomes are described.
