As with many other scientific researches, clinical trials require that data collection for the purposes of the trial need not only be accurate but also highly reliable. This is because the data is expected to present important information regarding the performance and prospects of the drug in question. With respect to the trial in question, Activity Based Costing (ABC) would be the most appropriate to deliver the desired results. The ABC method has the advantage of enhancing the outsourcing and planning for the clinical trial unlike the traditional methods of costing (John and Frederick, 2007, p. 37). Recently, pharmaceutical manufacturers and medical services providers have increasingly applied the ABC method in clinical trials to enable them to develop and distribute new medical products in the shortest time possible while reducing the production cost (Ezekiel et al, 2008, p. 78). For the effectiveness of the trial, the ABC would be applied so as to significantly reduce the cost and testing plus review time as this would significantly affect the life of the drug’s patent protection.
ABC is occasionally referred to as a ‘bottom-up approach’ or alternatively, ‘project-management approach’ and uses a different approach from the traditional approaches. The approach is used to determine the efforts level of particular resources and in considerations of this case finances that are meant to perform the given task. The effort level is usually calculated basing on an algorithm developed through experience, time drivers, and cost analysis affecting each activity (DeRenzo, 2005, p. 123). The effort is thus calculated in ‘work hours’ and this forms the basis for deriving the costs for the trial by factoring in the cost per hour of the person(s) performing the task. Thus, by compiling all costs involve in carrying out each task through the trial project, the total cost of the project is derived. ABC is an appropriate method as it offers the advantage of carrying out the trial with a breakdown structure for the work and thus once the time scale for the project has been estimated, it becomes easier to manage the trial to ensure accurate information is obtained (Ezekiel et al, 2008, p. 67). Unlike traditional top-down methods, ABC is bottom-up and takes care of underlying assumptions which may be conflicting thus making the necessary adjustments and amendments to deliver the desired results.
As the trial is focused on the estimation of important quantity-the effectiveness of the new osteoporosis drug, a disease-specific outcome measure is used. This is so because the trial resembles such studies as, oncology trials for dose-finding which are meant to estimate dose-toxicity levels in clinically related fields (Stuart, 1991, p. 97). Outcome measures thus go beyond the characterization of objectives for clinical trials, analysis, interpretation, and description. Therefore there are a number of considerations in the evaluation of a clinical trial outcome and which are generally intuitive. These considerations establish the basics for an outcome’s selection depending on the methodology since the outcome’s role is usually analogous to the role of diagnostic criteria (John and Frederick, 2007, p. 149).
For reliable results, this trial would use a surrogate outcome measurement for measuring the most meaningful clinical outcome as it has the ability to measure the extent of the progress of the disease. The measurement is significantly related to the definitive clinical outcome and thus serves as a reliable outcome measurement method (Ezekiel et al, 2008, p. 51). Surrogate measurement has an advantage in that it is easily accessible in terms of cost, ease of measurement, and time. According to DeRenzo (2005, p. 87), an appropriate surrogate is one that is both a valid test for the null hypothesis stating no relationship between the drug and the osteoporosis treatment group and also relevant for the corresponding null hypothesis founded on the true endpoint.
To be useful for this study, the surrogate ought not to be merely correlated with the trial outcome. It is therefore mandatory that the surrogate be reflective of the effects of the drug administration on the definitive outcome. A surrogate type that is a disease marker is applied so as to respond to therapy to an extent and frequency that is related to the treatment’s efficacy (Stuart, 1991, p. 85). This can also be used with the third surrogate which is a marker that addresses the clinical advantage of treatment.
References
DeRenzo, E & Moss, J. (2005). Writing Clinical Research Protocols: Ethical Considerations. New York: Academic Press.
Ezekiel, J., Grady, C., Crouch, R., Lie, R., Miller, F & Wendler, D. (2008). The Oxford Textbook of Clinical Research Ethics. New York: Oxford University Press.
John, L& Ognibene, F. (2007). Principles and Practice of Clinical Research, 2nd Ed. New York: Academic Press.
Stuart. J. (1991). Clinical Trials: A Practical Approach. New York: John Wiley & Sons.