Sample size estimation in clinical trial
Every clinical trial should be planned. This plan should include the objective of trial, primary and secondary end-point, method of collecting data, sample to be included, sample size with scientific justification, method of handling data, statistical methods and assumptions. This plan is termed as...
| Main Author: | |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wolters Kluwer Medknow Publications
2010-01-01
|
| Series: | Perspectives in Clinical Research |
| Subjects: | |
| Online Access: | http://www.picronline.org/article.asp?issn=2229-3485;year=2010;volume=1;issue=2;spage=67;epage=69;aulast=Sakpal |
| _version_ | 1818493837882949632 |
|---|---|
| author | Tushar Vijay Sakpal |
| author_facet | Tushar Vijay Sakpal |
| author_sort | Tushar Vijay Sakpal |
| collection | DOAJ |
| description | Every clinical trial should be planned. This plan should include the objective of trial, primary and secondary end-point, method of collecting data, sample to be included, sample size with scientific justification, method of handling data, statistical methods and assumptions. This plan is termed as clinical trial protocol. One of the key aspects of this protocol is sample size estimation. The aim of this article is to discuss how important sample size estimation is for a clinical trial, and also to understand the effects of sample size over- estimation or under-estimation on outcome of a trial. Also an attempt is made to understand importance of minimum sample to detect a clinically important difference. This article is also an attempt to provide inputs on different parameters that impact sample size and basic rules for these parameters with the help of some simple examples. |
| first_indexed | 2024-12-10T17:59:09Z |
| format | Article |
| id | doaj.art-2ae2361458af48b28ec26ca51f3db8cd |
| institution | Directory Open Access Journal |
| issn | 2229-3485 |
| language | English |
| last_indexed | 2024-12-10T17:59:09Z |
| publishDate | 2010-01-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Perspectives in Clinical Research |
| spelling | doaj.art-2ae2361458af48b28ec26ca51f3db8cd2022-12-22T01:38:50ZengWolters Kluwer Medknow PublicationsPerspectives in Clinical Research2229-34852010-01-01126769Sample size estimation in clinical trialTushar Vijay SakpalEvery clinical trial should be planned. This plan should include the objective of trial, primary and secondary end-point, method of collecting data, sample to be included, sample size with scientific justification, method of handling data, statistical methods and assumptions. This plan is termed as clinical trial protocol. One of the key aspects of this protocol is sample size estimation. The aim of this article is to discuss how important sample size estimation is for a clinical trial, and also to understand the effects of sample size over- estimation or under-estimation on outcome of a trial. Also an attempt is made to understand importance of minimum sample to detect a clinically important difference. This article is also an attempt to provide inputs on different parameters that impact sample size and basic rules for these parameters with the help of some simple examples.http://www.picronline.org/article.asp?issn=2229-3485;year=2010;volume=1;issue=2;spage=67;epage=69;aulast=SakpalSample sizestatistically significantclinically significantType I errorType II errorpower |
| spellingShingle | Tushar Vijay Sakpal Sample size estimation in clinical trial Perspectives in Clinical Research Sample size statistically significant clinically significant Type I error Type II error power |
| title | Sample size estimation in clinical trial |
| title_full | Sample size estimation in clinical trial |
| title_fullStr | Sample size estimation in clinical trial |
| title_full_unstemmed | Sample size estimation in clinical trial |
| title_short | Sample size estimation in clinical trial |
| title_sort | sample size estimation in clinical trial |
| topic | Sample size statistically significant clinically significant Type I error Type II error power |
| url | http://www.picronline.org/article.asp?issn=2229-3485;year=2010;volume=1;issue=2;spage=67;epage=69;aulast=Sakpal |
| work_keys_str_mv | AT tusharvijaysakpal samplesizeestimationinclinicaltrial |