Glaucoma clinical trial design: A review of the literature
The purpose of this article is to review the prior research evaluating design techniques for glaucoma clinical trials to help ophthalmologists and pharmaceutical sponsors better develop literature-based studies that are cost- and time-efficient. We performed this study using known published articles...
| Main Authors: | , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wolters Kluwer Medknow Publications
2014-01-01
|
| Series: | Perspectives in Clinical Research |
| Subjects: | |
| Online Access: | http://www.picronline.org/article.asp?issn=2229-3485;year=2014;volume=5;issue=3;spage=108;epage=114;aulast=Stewart |
| _version_ | 1818980723635257344 |
|---|---|
| author | William C. Stewart Jeanette A. Stewart Lindsay A. Nelson |
| author_facet | William C. Stewart Jeanette A. Stewart Lindsay A. Nelson |
| author_sort | William C. Stewart |
| collection | DOAJ |
| description | The purpose of this article is to review the prior research evaluating design techniques for glaucoma clinical trials to help ophthalmologists and pharmaceutical sponsors better develop literature-based studies that are cost- and time-efficient. We performed this study using known published articles by the authors and literature found on Pub Med. We included 24 articles that analyzed specifically the results of clinical trial methods and/or interpretation. This review found that studies have evaluated glaucoma specific aspects of glaucoma clinical trials including: Predicting the results of later phase clinical trials based on early phase clinical trials and animal studies; protocol design parameters such as intraocular pressure, inclusion criteria, method of pressure measurement, study population, and side effect evaluation; and study planning issues such as number of clinical sites as well as subjects, dropout rates, estimated serious adverse events, and protocol violations. This review suggests that the medical literature supports some aspects of glaucoma clinical trial study design. Additional design features might be derived from government regulations, guidance, as well as agency contacts, consultants, and clinical community standards. Study design decisions that must be made beyond the aforementioned resources should be made carefully, with appropriate consultation as needed, considering the risk/benefit ratio to the study. However, more research is needed to better evaluate the design procedures and methods involved in glaucoma clinical trials to best provide a cost- and time-efficient study while achieving quality efficacy and safety results. |
| first_indexed | 2024-12-20T17:19:58Z |
| format | Article |
| id | doaj.art-4dac3c0a07a04db9bc60562d46120b82 |
| institution | Directory Open Access Journal |
| issn | 2229-3485 |
| language | English |
| last_indexed | 2024-12-20T17:19:58Z |
| publishDate | 2014-01-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Perspectives in Clinical Research |
| spelling | doaj.art-4dac3c0a07a04db9bc60562d46120b822022-12-21T19:31:53ZengWolters Kluwer Medknow PublicationsPerspectives in Clinical Research2229-34852014-01-015310811410.4103/2229-3485.134306Glaucoma clinical trial design: A review of the literatureWilliam C. StewartJeanette A. StewartLindsay A. NelsonThe purpose of this article is to review the prior research evaluating design techniques for glaucoma clinical trials to help ophthalmologists and pharmaceutical sponsors better develop literature-based studies that are cost- and time-efficient. We performed this study using known published articles by the authors and literature found on Pub Med. We included 24 articles that analyzed specifically the results of clinical trial methods and/or interpretation. This review found that studies have evaluated glaucoma specific aspects of glaucoma clinical trials including: Predicting the results of later phase clinical trials based on early phase clinical trials and animal studies; protocol design parameters such as intraocular pressure, inclusion criteria, method of pressure measurement, study population, and side effect evaluation; and study planning issues such as number of clinical sites as well as subjects, dropout rates, estimated serious adverse events, and protocol violations. This review suggests that the medical literature supports some aspects of glaucoma clinical trial study design. Additional design features might be derived from government regulations, guidance, as well as agency contacts, consultants, and clinical community standards. Study design decisions that must be made beyond the aforementioned resources should be made carefully, with appropriate consultation as needed, considering the risk/benefit ratio to the study. However, more research is needed to better evaluate the design procedures and methods involved in glaucoma clinical trials to best provide a cost- and time-efficient study while achieving quality efficacy and safety results.http://www.picronline.org/article.asp?issn=2229-3485;year=2014;volume=5;issue=3;spage=108;epage=114;aulast=StewartClinical trialglaucomatrial designtrial methods |
| spellingShingle | William C. Stewart Jeanette A. Stewart Lindsay A. Nelson Glaucoma clinical trial design: A review of the literature Perspectives in Clinical Research Clinical trial glaucoma trial design trial methods |
| title | Glaucoma clinical trial design: A review of the literature |
| title_full | Glaucoma clinical trial design: A review of the literature |
| title_fullStr | Glaucoma clinical trial design: A review of the literature |
| title_full_unstemmed | Glaucoma clinical trial design: A review of the literature |
| title_short | Glaucoma clinical trial design: A review of the literature |
| title_sort | glaucoma clinical trial design a review of the literature |
| topic | Clinical trial glaucoma trial design trial methods |
| url | http://www.picronline.org/article.asp?issn=2229-3485;year=2014;volume=5;issue=3;spage=108;epage=114;aulast=Stewart |
| work_keys_str_mv | AT williamcstewart glaucomaclinicaltrialdesignareviewoftheliterature AT jeanetteastewart glaucomaclinicaltrialdesignareviewoftheliterature AT lindsayanelson glaucomaclinicaltrialdesignareviewoftheliterature |