What is a non-inferiority study?

What is a non-inferiority study?

Active control trials aim to demonstrate that treatments of interest have either superior effects or similar effects to the control. If the intent of a study is to demonstrate that an experimental treatment is not substantially worse than a control treatment, the study is known as a noninferiority trial.

How do you determine non-inferiority?

Noninferiority trials are used to assess whether the effect of a new drug is not worse than an active comparator by more than a noninferiority margin. If the difference between the new drug and the active comparator does not exceed this prespecified margin, noninferiority can be concluded.

How do you choose non-inferiority margin?

In order to demonstrate non-inferiority, the recommended approach is to pre-specify a margin of non- inferiority in the protocol. After study completion, a two-sided 95% confidence interval (or one-sided 97.5% interval) for the true difference between the two agents will be constructed.

What is null hypothesis clinical trial?

Recall that the null hypothesis (H0) is a stated value of the population parameter that is set up to be refuted. For example, in a clinical trial with an intervention and a control group, the null hypothesis generally proposes that the intervention and control are equally as effective or ineffective.

What is P-value in clinical trials?

In statistical science, the p-value is the probability of obtaining a result at least as extreme as the one that was actually observed in the biological or clinical experiment or epidemiological study, given that the null hypothesis is true [4]. There are two hypotheses, the null and the alternative.

What is Alpha in a clinical trial?

The probability of making an error is called α (“alpha”) and the probability of avoiding error is 1–α. Rather than specify alpha ahead of time, many people like to look afterwards and see what the risk of Type I error is for the data actually obtained. This is called the p–value.

What is a futility analysis?

The term ‘futility’ is used to refer to the inability of a clinical trial to achieve its objectives. In particular, stopping a clinical trial when the interim results suggest that it is unlikely to achieve statistical significance can save resources that could be used on more promising research.

What is Alpha spending?

Alpha-spending is an approach of distributing (spending) the type I error (denoted alpha) over the duration of a sequential A/B test. Alpha-spending makes it possible to perform sequential testing while maintaining the overall error probability of the procedure.

What is interim analysis in clinical trials?

The term ‘interim analysis’ is used to describe an evaluation of the current data from an ongoing trial, in which the primary research question is addressed, and which has the potential for modifying the conduct of the study. …

What is a futility boundary?

A futility boundary (futility stopping boundary, rarely futility limit) is a statistical decision boundary used in sequential testing such as an AGILE A/B test. A binding futility bound is calculated in such a way, that the error guarantees hold if any boundary cross results in an immediate termination of the A/B test.

What is interim data?

Scientific information that is studied part way through a medical research project to see whether there are hazards associated with the study or clear benefits from one treatment or another.

Why is interim data analysis important in action research?

Interim analysis of accumulating trial data is important to protect participant safety during randomized controlled trials (RCTs)

What is group sequential design?

A group sequential design is a type of adaptive design where the number of patients isn’t set in advance. Patients are divided into an equal number of groups and data is analyzed at pre-determined points in the trial. A stopping rule specifies when and why a trial might be halted at these points

What interim means?

for, during, belonging to, or connected with an intervening period of time; temporary; provisional: an interim order; an interim job.

What does interim mean in medical terms?

1. An intervening period. 2. Temporary, preliminary, or provisional. Medical Dictionary, © 2009 Farlex and Partners.

How do you use the word interim?

Interim in a Sentence ?

1. While my car is in the shop, I think I’ll borrow Dad’s Corvette for getting around during the interim.
2. You should be cured of your cold within fourteen days, but take these pills in the interim to help with your symptoms.

What is an interim summary?

Definition of Interim summary A segment of instruction that reviews recent learning to reinforce prior information.

What does report status interim means?

temporary measuremant

What is the purpose of an interim report?

Interim statements are financial reports produced by firms covering a period of less than one year. The goal is to keep shareholders and analysts more up-to-date and in regular communication with corporate management, and to alert the public to material changes to the company in a timely fashion

Why is interim reporting needed?

“Timely and reliable interim financial reporting improves the ability of investors, creditors and others to understand an enterprise’s capacity to generate earnings and cash flows, its financial condition and liquidity.”

How do you write an interim report?

You may be required to produce an interim report as part of a larger project, such as your final Individual Project….Your interim report should:

1. State your aims and objectives.
2. Explain your research.
3. Show what you have achieved.
4. Demonstrate the steps to complete the project on time.

What is popular report?

Definition. Popular reports are reports that aim at informing citizens about the financial condition of the state/ local government in a convenient and friendly manner. They are expected to be concise, short in length, and present public sector accounting information in a simplified way.

Who is required to prepare interim financial statements?

About. An interim financial report is a complete or condensed set of financial statements for a period shorter than a financial year. IAS 34 does not specify which entities must publish an interim financial report. That is generally a matter for laws and government regulations.

What is a summary report?

A summary report is a short, written communication which may have a variety of purposes, such as: To brief the reader on the details of a particular event. To analyse a particular issue, draw conclusions and make recommendations. To convince the reader of the importance of taking a particular course of action.