This might be difficult to quantify upfront (e.g. The complexities associated with adaptive designs may mean they require additional resource to develop and conduct.
Additionally, trials using adaptive designs are usually more complex and may require more effort to set up, manage, monitor, analyse, and close. One important area that has received less attention relates to the cost and resource needed to implement adaptive designs, which generally require interim analyses to be conducted quickly and to a high level of quality. Adaptive designs have been widely and successfully used in trials of COVID-19 prevention and treatment, which will likely lead to further demand for their use. Although there is still more to do, these barriers are being steadily addressed, especially for less complex adaptive methods.
#How to use the model resource software
These include lack of awareness of their purpose and potential, expertise, training, and availability of easy-to-use software for implementation, alongside a paucity of experiences in their delivery. Some barriers to increased use have already been identified ).
#How to use the model resource trial
The use of adaptive designs has been increasing in recent years although it still remains low when compared to traditional trial designs. Generally, they have one or more of the following objectives compared to traditional trial designs: (1) improving the power of the trial, (2) reducing the average sample size used and trial duration for a target level of power, and (3) improving outcomes of patients who are enrolled on the trial. There are many types of adaptive trial designs that can be used for different purposes. An adaptive design, according to the adaptive CONSORT extension, ‘offers pre-planned opportunities to use accumulating trial data to modify aspects of an ongoing trial while preserving the validity and integrity of that trial’. One important class of methods is adaptive trial designs. Because of this, there has been a big drive towards developing trial methods that can increase operational and statistical efficiency. The cost of conducting trials is high and is increasing it is a major factor behind the increasing costs of drug development and evaluation of non-pharmacological interventions. Informed by the results of this research, guidance for investigators and funders will be developed on appropriately resourcing adaptive trials.Ĭlinical trials are vital for demonstrating safety, efficacy, and effectiveness of interventions aimed at improving patient health. The percentage increase in costs for supporting an adaptive trial was generally modest and should not be a barrier to adaptive designs being cost-effective to use in practice. This work sheds light on additional resources required to adequately support a high-quality adaptive trial. The interviews identified possible explanations for differences, including (1) experience in adaptive trials, (2) the complexity of the non-adaptive and adaptive design, and (3) the extent of non-trial specific core infrastructure funding the CTU had. The percentage increase in resources varied across different CTUs. The highest increase was for statistical staff, with lower increases for data management and trial management staff. The median increase was between 2 and 4% for all scenarios, except for sample size re-estimation which was 26.5% (as the adaptive design could lead to a lengthened study period). ResultsĮstimated resources associated with conducting an adaptive trial were always (moderately) higher than for the non-adaptive equivalent. Interviews with 10 CTU staff who had completed the costing exercise were conducted by qualitative researchers to explore reasons for similarities and differences. This was calculated separately for the non-adaptive and adaptive version of the trial, allowing paired comparisons. statistics, data management, trial management). Each scenario represented a different type of adaptive design.ĬTU staff were asked to provide the costs and staff time they estimated would be needed to support the trial, categorised into specified areas (e.g.
Five scenarios were developed, derived from funded clinical trials, where a non-adaptive version and an adaptive version were described. We conducted a mock costing exercise amongst seven Clinical Trials Units (CTUs) in the UK. The Costing Adaptive Trials (CAT) project investigated which additional resources may be required to support adaptive trials. An important barrier to further increased use is a lack of understanding about which additional resources are required to conduct a high-quality adaptive clinical trial, compared to a traditional fixed design. Adaptive designs offer great promise in improving the efficiency and patient-benefit of clinical trials.
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