System and method for continuous data analysis of an ongoing clinical trial

Abstract

System and method of continuously analyzing trial data of an ongoing clinical trial is provided. A statistical analysis is performed on a trial database containing subject trial data. If the result of the statistical analysis does not exceed a predetermined threshold value, then the statistical analysis is repeated while the clinical trial is ongoing. In a blinded clinical trial, a grouped database is generated from the trial database and a blinding database prior to performing the statistical analysis. The grouped database groups the subject trial data according to the study groups. The ability to continuously monitor and analyze the trial data for statistical significance in tandem with data collection while the trial is ongoing provides many benefits to the researchers because the trial database no longer becomes the bottleneck in obtaining useful results and statistical analysis can be conducted on a near real-time basis without having to wait until completion of the trial.

Description

TECHNICAL FIELD OF THE INVENTION [0001] This application relates to data processing of clinical trial data and more specifically a system and method for statistically analyzing the clinical trial data. BACKGROUND OF THE INVENTION [0002] In the United States, the Food and Drug Administration (FDA) oversees the protection of consumers exposed to health-related products ranging from food, cosmetics, drugs, gene therapies and medical devices. Under the FDA guidance, clinical trials are performed to test the safety and efficacy of new drugs, medical devices or other treatments to ultimately ascertain whether or not a new medical therapy is appropriate for widespread human consumption. [0003] More specifically, once a new drug or medical device has undergone studies in animals, and results appear favorable, it can be studied in humans. Before human testing is begun, findings of animal studies are reported to the FDA to obtain approval to do so. This report to the FDA is called an applicat...

AI Technical Summary

Problems solved by technology

This could skew the data and outcome of the clinical trial to favor the medication under study, by the selection of subjects who are most likely to perform well with the medication.

However, these methods lead to several challenges, since they prevent the clinical trial sponsor from tracking key information related to safety and efficacy.

Unfortunately, because the study arm assignments are blinded, there is no way to separate out subjects and their data into corresponding groups for purposes of performing comparisons while the trial is being conducted.

Since many clinical trials may last for time periods extending for years, it is conceivable to have a treatment toxicity go unnoticed for prolonged periods without intervention.

These parameters, including both key variables and study endpoints, cannot be analyzed by comparison between study arms while the subjects are randomized and blinded.

This poses potential problems in ethics and statistical analysis.

Conversely, when available, it is considered unethical to withhold such treatments.

For example, if a medication were to be identified that eradicated the Human Immunodeficiency Virus (HIV), it would be unethical to allow diseased patients to continue suffering and even die of the illness, while the medication was being clinically tested for purposes of government approval.

At present, when clinical trials are randomized and blinded, identification of a particularly effective treatment may not be realized until the entire clinical trial is completed.

Another related problem is statistical power.

When too few subjects are enrolled into the study arms, there is the risk of the study not accruing enough subjects to enable the null hypothesis to be rejected, and thus not reaching statistical significance.

Although this maintains data collection integrity, there are inherent inefficiencies in the system, regardless of the outcome.

While that moment ma...

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