Time to mandate data release and independent audits for all clinical trials
| Autor: | Ian E. Haines, George L Gabor Miklos |
|---|---|
| Rok vydání: | 2011 |
| Předmět: |
Male
medicine.medical_specialty Time Factors Alternative medicine Antineoplastic Agents Audit Risk Assessment Disease-Free Survival Neoplasms Statistical analyses medicine Humans Intensive care medicine Drug Approval Medical Audit business.industry Australia General Medicine Patient data Mandatory Reporting Survival Analysis Clinical trial Clinical Trials Phase III as Topic Mandate Female Periodicals as Topic business Data release |
| Zdroj: | Medical Journal of Australia. 195:575-577 |
| ISSN: | 1326-5377 0025-729X |
| DOI: | 10.5694/mja11.10599 |
| Popis: | reduces costs.Definitive proof of therapeutic benefit relies on freely accessible, high-quality data and their independent evaluation. Unfortunately, open access to de-identified patient data and statistical analyses remains unavailable, so only limited verification of claims emanating from commercially sponsored clinical trials is possible. This restriction reinforces concerns about reporting of trials in general, as “overestimation of the clinical benefit of a drug” is well documented. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Plný text