The Proposed Rule for U.S. Clinical Trial Registration and Results Submission

Zarin, Deborah A.; Tse, Tony; Sheehan, Jerry

doi:10.1056/nejmsr1414226

Cited by 89 publications

(60 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…This pattern is also reflected in the growing rate of registered phase 2 and 3 trials. The implementation of laws regulating the necessity of and improvements in clinical trial registration might be responsible for the apparent growth in the number of glaucoma trials [34] . Furthermore, even in the re-gions where clinical trials are regulated and compulsory, laws tend to exclude all trial types, e.g., phase 1 trials and device trials.…”

Section: Discussionmentioning

confidence: 99%

Open-Angle Glaucoma: Drug Development Pipeline during the Last 20 Years (1995-2015)

et al. 2017

View full text Add to dashboard Cite

Objectives: To analyse drug development for open-angle glaucoma during the last 20 years. Methods: Research was performed by referring to clinical trials registered at the International Clinical Trials Registry Platform (ICTRP). A search for the condition “open-angle glaucoma” with the intervention “drug” was performed. We included trials registered from 01/01/1995 to 01/01/2015, only involving studies in phases 1, 2, and 3. Only studies resorting to novel treatment strategies (either novel drugs or yet-untested fixed associations of approved medication) were considered. Results: We recorded 158 studies for the condition of open-angle glaucoma with a drug-based intervention; 65 of the studies reported phase 2 trials and 74 reported phase 3 trials. Pharmaceutical companies were the primary sponsors of 95.3% of the trials. Most of the studies (66.5%, n = 105) involved a new drug, and the remainder (33.5%, n = 53) tested fixed drug associations. The bulk of the trials (n = 99, 62.7%) involved the use of prostaglandin analogues, either as a comparator or a study drug. In descending order of frequency, the studies conducted involved Rho-kinase inhibitors (n = 15), carbonic anhydrase inhibitors (n = 14), β-blockers (n = 7), angiostatic steroids (n = 6), α₂-adrenergic agonists (n = 4), 5-HT_2A receptor agonists (n = 4), and NMDA receptor antagonists (n = 2). A cyclin-dependent kinase inhibitor, an LIM-domain kinase 2 inhibitor, an A1 adenosine receptor agonist, catechin, macrolide, saffron, and seawater were each tested in 1 clinical trial. Conclusion: Research into the medical treatment of glaucoma indicates the use of prostaglandin analogues. However, there are a significant number of trials testing other drug classes, particularly Rho-kinase inhibitors. This new focus could lead to a potential increase in the number of therapeutical options for the management of glaucoma in the future.

show abstract

Section: Discussionmentioning

confidence: 99%

Open-Angle Glaucoma: Drug Development Pipeline during the Last 20 Years (1995-2015)

et al. 2017

View full text Add to dashboard Cite

show abstract

“…The manufacturers did not provide the reports upon our request, and to obtain them from the FDA would have required a Freedom of Information Act request, which can be time-consuming and can lead to production of redacted reports. There have been movements for greater transparency of clinical trials, both in the US and EU, from both governmental and professional organizations [42], but ClinicalTrials.gov and similar efforts often do not extend to bioequivalence studies [43]. The methods and data from bioequivalence studies comparing brand-name and generic drugs that are submitted to a regulatory authority for approval should be routinely made available immediately upon the approval of the generic drug, as is now increasingly occurring for newly approved brand-name drugs.…”

Section: Discussionmentioning

confidence: 99%

Modified Regulatory Pathways to Approve Generic Drugs in the US and a Systematic Review of Their Outcomes

Kesselheim

Fulchino

Isaman

et al. 2015

Drugs

View full text Add to dashboard Cite

Pharmaceutical manufacturers sometimes raise scientific concerns related to potential generic versions of their drugs; however, in the six cases we reviewed, these companies did not follow up the pre-approval concerns they raised with any methodologically rigorous post-approval testing using clinical endpoints. Despite their pre-approval controversy, experience with these generic drugs provides reassurance of their clinical interchangeability. Systematized post-approval study of certain generic drug bioequivalence determinations is needed.

show abstract

“…Registries enhance transparency by providing an inventory of studies that are in progress or have been completed. [8][9][10] Empirical analyses of prospective registration of studies (defined here as registration of investigational studies prior to enrollment of the first patient or, for observational studies, prior to initial analyses) can inform on the time between study completion and publication, the number of unpublished studies, the fidelity of studies to registered protocols, and the congruence of study results between registry records and publications. [11][12][13][14] This methods report assesses the value of searching ClinicalTrials.gov and ICTRP registry records in a systematic review of dietary supplements.…”

Section: Background and Objectivesmentioning

confidence: 99%

Supplemental Project to Assess the Transparency of Reporting Requirements: Omega-3 Fatty Acids and Cardiovascular Disease

Legault¹

2017

View full text Add to dashboard Cite

The Proposed Rule for U.S. Clinical Trial Registration and Results Submission

Cited by 89 publications

References 14 publications

Open-Angle Glaucoma: Drug Development Pipeline during the Last 20 Years (1995-2015)

Open-Angle Glaucoma: Drug Development Pipeline during the Last 20 Years (1995-2015)

Modified Regulatory Pathways to Approve Generic Drugs in the US and a Systematic Review of Their Outcomes

Supplemental Project to Assess the Transparency of Reporting Requirements: Omega-3 Fatty Acids and Cardiovascular Disease

Contact Info

Product

Resources

About