{ Study Design and Protocol Development }
A randomized, controlled trial can provide the most compelling evidence that a medicine or treatment under study causes an expected effect on human health. DaVita Clinical Research (DCR) scientists work with you to design a study formulated from the very beginning with the requirements and preferences of regulatory agencies in mind. DCR scientists are thoroughly knowledgeable in the regulations, requirements, and report formats of FDA and other regulatory agencies and can help design trials with the best chance of approval.
Whether comparing a compound to placebos or the prevailing standard of care, DCR can help evaluate alternative study designs, calculate sample sizes and sampling times, recommend randomization and blinding techniques, and advise on the formulation of parameters. From this, a protocol is developed describing the scientific rationale, objective, methodology, statistical considerations, and organization of the planned trial.
