1.32 Interim Clinical Trial/Study Report:
A report of intermediate results and their evaluation based on analyses performed during the course of a trial
.
What is interim study?
In clinical trials and other scientific studies, an interim analysis is
an analysis of data that is conducted before data collection has been completed
. Clinical trials are unusual in that enrollment of subjects is a continual process staggered in time.
What does a clinical study report include?
A clinical study report provides
a clinical and statistical description, presentations and analyses of the completed study
. The clinical study report should include an explanation of the critical design features, the plan, methods and conduct of the study, individual patient data and details of analytical methods.
What is the purpose of a clinical study report?
A clinical study report (or CSR for short) describes the endpoints or outcomes being researched,
provides details on how the data were collected and analyzed, and confirms whether the study endpoints were met or outcomes were achieved
.
What is the purpose of interim analysis in clinical trial?
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.
Is a clinical study report required?
CSRs are
required by regulatory authorities
to report and summarize the outcomes of a clinical study.
How do you summarize a clinical study?
The executive summary should include a
brief 3-4 sentence summary, key messages, and conclusions from the paper
. Include graphics or tables as needed. Remember to be concise and clear. Doctors, nurses, and clinical staff should be able to understand the information presented without additional explanation.
Is a interim report?
An interim statement is
a financial report covering a period of less than one year
. … Interim statements increase communication between companies and the public and provide investors with up-to-date information between annual reporting periods. These may also be referred to as interim reports.
What does interim mean in medical terms?
1. An intervening period. 2.
Temporary, preliminary, or provisional
.
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. See also: data.
What is case study report in clinical trials?
Definition of case report and clinical study
In medicine, a case report is
a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient
. Case reports may contain a demographic profile of the patient, but usually describe an unusual or novel occurrence.
What is clinical study protocol?
A clinical study protocol is
a document that describes the study objectives, design, methods, assessment types, collection schedules, and statistical considerations for analyzing the data
. The protocol also outlines steps for protecting subjects and obtaining quality data.
What does TLF mean in clinical trials?
Finally, all supporting reports in the form of
Tables, Listings and Figures
(TLF). Figures are also referenced as Graphs in which case the acronym becomes TLG.
What are the methods to perform interim analysis?
The three most commonly used techniques are
Pocock, Haybittle/Peto, and O’Brien/Fleming
. The differences among the three techniques mostly concern how much of the alpha is spent and when. FIGURE 15.40. Statistical boundaries for interim analysis.
Why are secondary endpoints studied?
Understanding Clinical Trials
Secondary endpoints answer
other relevant questions about the same study
; for example, whether there is also a reduction in disease measures other than death,
33
or outcomes rated by patients such as quality of life
34
.
What is a futility analysis in clinical trials?
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.
