Clinical studies/trials costs

CEO, Stephen Hoffman and VP for clinical studies, Michael Gerber of Alios Therapeutics guided RSR 13 through a series of phase-one and phase-two clinical trials for radiation treatment of brain tumors and for potential use in cardiopulmonary bypass surgery [46, 51-55]. Considering the cost of running a phase-three clinical trial, only one was possible. The very positive phase-two results for use of RSR 13 to treat metastatic brain cancer provided the impetus for selecting that indication for a phase-three trial. 

The use of estimates of treatment effect based on indirect comparisons when there is a common comparator has recently been shown on many occasions to agree with the results of head-to-head clinical trials (Song et al. 2003). Clearly a more challenging situation exists where there is not a common parameter, for example, in a recent study of the relative cost effectiveness of newer drugs for treatment of epilepsy (Wilby et al. 2003). In this study, Bayesian Markov chain Monte Carlo models for multiparameter synthesis were used (Ades 2003). Here, complex models were used to analyze a set of clinical studies involving a series of clinical alternatives, including the two alternatives of interest. 

The best evidence about the effects of chemical exposure on human health would come from clinical trials, but they are generally not used because of ethical concerns about experimentation on humans. Even when clinical drug trials are conducted, the prohibitive cost of large studies means that the smallest incidence change that can be detected is about 1 percent. 

The CATIE project will evaluate the clinical effectiveness of atypical antipsychotics in the treatment of schizophrenia and of Alzheimer s disease. Although antipsychotics were first introduced for the treatment of schizophrenia, they are now used for many other disorders. It is unclear how effective they are and, most important, in view of their rather high cost, how favorably they compare to the first generation of antipsychotics, all of which are available in generic (and thus much less expensive) forms. The CATIE (Clinical Antipsychotic Trials in Intervention Effectiveness) study has specific aims, including the determination of long-term effectiveness and tolerability of the atypical antipsychotics, compared to each and to a typical or classic antipsychotic. At this... 

The number, type, and cost of clinical studies or trials (including number of patients and sites) required in each phase of development to complete the project ... 

A well planned simulation project increases the likelihood of providing meaningful and timely simulation results that will enhance the design and improve the efficiency, robustness, power, and informativeness of preclinical and clinical studies. An increase in the efficiency and power of clinical trials should reduce the number of studies and time needed to complete the drug development process with the resultant reduction in cost of pharmacotherapy to the consumer. 

Only ABLC and liposomal amphotericin B have been approved for use in proven candidiasis. Both in vivo and clinical studies indicate that these compounds are less toxic but as effective as amphotericin B when used in appropriate dosages. Nevertheless, their higher cost and the paucity of randomized trials in proven invasive candidiasis limit their front-line use in these infections. ... 

Among a highly diverse collection of study conduct service providers—from academic medical centers to dedicated and part-time independent investigative sites— SMOs appear well positioned to meet growing demands for faster development cycle time, improved data quality, and controlled clinical trial costs. Conceptually, SMOs vie to support their positioning through the following mechanisms ... 

Comparisons for total clinical trial costs can also be made among countries (Fig. 42.2) may come as a surprise to many that the UK, on the basis of this evidence, comes out the most expensive, although the relatively lower cost of Italy and Spain is more expected. A wider variation in the relative costs of studies for both Europe and the USA is seen. It should be emphasized that these relative costs do not depend on the length and complexity of the study, but are reflective of the fee levels expected by the physicians running the studies and, to a lesser extent, the cost of the investigative procedures. 

The attractiveness of China and India is primarily due to their lower operational costs relative to the US, Europe or Japan - especially for clinical trials, though there is increasing awareness that these are potential markets for the future. Clinical studies help raise the awareness and demand for an improved standard of care with both physicians and patients. The general costs for clinical trials in China are much lower than those in the major pharmaceutical markets (49J. Current thinking suggests that in terms of general rurming costs, chnical... 

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