Adaptive Clinical Trial Analysis

Adaptive Clinical Trial Analysis

Adaptive clinical trial refers to an experimental design that modifies some aspects of the experimental design dynamically after the clinical trial starts, according to the information accumulated in the trial, without damaging the validity, scientificity and integrity of the trial. The purpose of adaptive trials is to identify drugs or devices that have therapeutic effects more quickly and to focus on the appropriate patient population of the drug. The adaptive modifications that can be made during clinical trial implementation are included in Figure 1.

Adaptive Clinical Trial Analysis

Figure 1. The adaptive modifications of adaptive clinical trial

Adaptive design has been widely used in clinical trials in recent years because of its incomparable advantages, but the statistical analysis to it is still a difficult process. Our experts will analyze various factors and select appropriate statistical methods to help you complete the analysis of adaptive clinical trials.

Our Services

Our experts will help you to develop a clear and comprehensible plan to process the analysis of adaptive clinical trials. Based on this goal, we will provide the services as follows:

  • The adjustment of the sample size

In general, the sample size is determined before the formal start of the trial based on the estimate of the minimum amount of effect of clinical significance between the treatment and control groups and the estimated variance between the participants. Incorrect initial parameters can lead to underpowered design. These parameters are better estimated using interim data, and then the sample size is adjusted according to these estimates to achieve desirable study goals. We will use effective statistical methods to re-evaluate the sample size to accurately adjust the sample size of the experiment.

  • The adjustment of therapeutic dose

We will adjust the experimental scheme appropriately according to the information accumulated in the trial, and one of the most important parts of that is adjusting the therapeutic dose. The common dose-finding designs include but are not limited to continuous reappraisal (CRM), average continuous reappraisal (BMA-CRM) of Bayesian models, and excessive control escalation (EWOC) designs. Our experts will select appropriate statistical methods for you to help you adjust the therapeutic dose.

  • The adjustment of the allocation of treatment among groups

The adjustment of the allocation of treatment among groups brings a higher possibility that more patients would be assigned to more effective treatments, thus improving the individual ethics of the trial and benefiting the patients participating in the trial. We usually use Bayesian adaptive randomization designs to process this service. We will use an equal randomization phase at the beginning of the trial to gather information on treatment efficacy, and then calculate the posterior probability that each treatment has the highest therapeutic effect. After those steps, the next new patient can be randomized to a treatment with a randomization probability that is proportional to the associated posterior probability. Our experts will conduct reasonable investigation for you to carry out adaptive randomization.

  • The determination of stopping the trials

Generally, a trial starts with a large sample size at early stage, but if the cumulative data indicates that a large sample size is not required, we can terminate the trial early. Furthermore, if the study is unlikely to achieve its main goal, we can help you to make a decision to stop the study. This can save resources and prevent participants from being exposed to the limited value of treatment. Our experts will systematically analyze the accumulated data to accurately determine whether to terminate the experiment.

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.

If you are unable to find the specific service you are looking for, please feel free to contact us.

1. Elsäßer A, Regnstrom J, Vetter T, et al. (2014) ‘Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency’, Trials, 15(1), 383.
2. Zang Y, Lee J J. (2014) ‘Adaptive clinical trial designs in oncology’, Chinese Clinical Oncology, 3(4).
3. Scott A. Elman, James H. Ware, Alice B. Gottlieb, et al. (2016) ‘Adaptive Clinical Trial Design: An Overview and Potential Applications in Dermatology’, J Invest Dermatol, 136(7):1325-1329.

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