The reason why interim analysis is widely used is the soaring cost of clinical research and significant trial failures. In clinical trials and other scientific studies, interim analysis is often performed before the completion of the trial, and the intention of this analysis is to determine whether the trial is terminated prematurely or to adjust the sample size. Interim analysis of clinical trials keeps the decision process free of conflict of interest while considering cost, resources and meaningfulness of the project. This reasonable approach helps to analyze and predict the results of clinical trials. If necessary, such an interim analysis can also call for early termination or appropriate modification of the sample size, study design, or even early declaration of success.
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Our experts will help you to develop a clear and comprehensible plan to process the interim analysis of your trial. Based on this goal, the design of interim analysis for the various clinical trials constitutes most of our work.
The time of conducting an interim analysis affects the probability of the early termination and the number of subjects enrolled prior to the interim analysis. Thus, confirming the optimal time for interim analyses helps you minimize the expected sample size and reduce costs in confirmatory trials. However, confirming the best time to do the interim analysis is always a difficulty. According to relevant research, the optimal time of one interim analysis for the early termination is approximately two-thirds of the planned observations for the O Brien Fleming type, and approximately half of the planned observations for the Pocock type. We can analyze the best time for the interim analysis according to the different type of the trials, and help you complete the trials and reduce the cost.
Assessing the possible scenarios needs rich experience in clinical trials, and we will use techniques such as meta-analysis to rigorously evaluate directly related trials. At the same time, we will regularly record the likely relative efficiency of the treatments and the clinical benefits before a new treatment so that we can provide you with actual assessment of possible scenarios. Through the above methods, we can help you assess the possible scenarios, which will facilitate the smooth running of your trials.
Mortality and excessive toxicity are obvious points to stop trials, but lots of complex features such as quality of life are much more difficult to assess and analyze. We will assess and analyze nearly all the possible end points of the trials according to the results of the interim analysis. From this, we will make the decision to stop a trial or not based on early information.
We guarantee the confidentiality and sensitivity of our customers' data. We are committed to providing you timely and high-quality deliverables. At the same time, we guarantee cost-effective, complete and concise reports.
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References:
1. Kumar A, Chakraborty B S. (2016) ‘Interim analysis: A rational approach of decision making in clinical trial’, Journal of Advanced Pharmaceutical Technology & Research, 7(4):118-122.
2. KanaeTogo, ManabuIwasaki. (2013) ‘Optimal Timing for Interim Analyses in Clinical Trials’, Journal of Biopharmaceutical Statistics, 23(5):1067-1080.
3. O'Fallon J R. (1985) ‘Policies for interim analysis and interim reporting of results’, Cancer Treatment Reports, 69(10):1101.