Perspectives on clinical trial data transparency and disclosure
| Autor: | R.J. Anziano, Demissie Alemayehu, Marcia Levenstein |
|---|---|
| Rok vydání: | 2014 |
| Předmět: |
Clinical Trials as Topic
Health Information Exchange Drug Industry business.industry Management science Patient privacy Best practice Guidelines as Topic Disclosure General Medicine Public relations Transparency (behavior) Scientific integrity Data sharing Dilemma Clinical trial Data transparency Humans Medicine Pharmacology (medical) Guideline Adherence business Confidentiality |
| Zdroj: | Contemporary Clinical Trials. 39:28-33 |
| ISSN: | 1551-7144 |
| DOI: | 10.1016/j.cct.2014.07.002 |
| Popis: | The increased demand for transparency and disclosure of data from clinical trials sponsored by pharmaceutical companies poses considerable challenges and opportunities from a statistical perspective. A central issue is the need to protect patient privacy and adhere to Good Clinical and Statistical Practices, while ensuring access to patient-level data from clinical trials to the wider research community. This paper offers options to navigate this dilemma and balance competing priorities, with emphasis on the role of good clinical and statistical practices as proven safeguards for scientific integrity, the importance of adopting best practices for reporting of data from secondary analyses, and the need for optimal collaboration among stakeholders to facilitate data sharing. |
| Databáze: | OpenAIRE |
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