Clinical trial database

Definition

A clinical trial database is a structured collection of data that contains information about clinical trials, including study protocols, participant demographics, outcomes, and results. This type of database serves as a critical resource for researchers, regulatory bodies, and other stakeholders to access and analyze data from numerous trials, promoting transparency and improving the quality of clinical research.

5 Must Know Facts For Your Next Test

1. Clinical trial databases are essential for ensuring that clinical trial data is easily accessible and can be systematically analyzed by researchers and regulators alike.
2. These databases often include metadata about each trial, such as phase, type of intervention, outcomes measured, and funding sources.
3. Many regulatory bodies require the submission of clinical trial data into public databases to enhance transparency and protect participants' rights.
4. Data from clinical trial databases can be used to perform meta-analyses, helping to identify trends and efficacy across multiple studies.
5. The availability of robust clinical trial databases is crucial for harmonization efforts among international regulatory bodies, facilitating global collaboration in drug development.

Review Questions

• How do clinical trial databases contribute to the transparency and integrity of clinical research?
  • Clinical trial databases enhance transparency by providing public access to detailed information about ongoing and completed trials, which helps ensure that researchers conduct studies ethically and that results are reported accurately. By allowing stakeholders to review protocols, participant demographics, and outcomes, these databases encourage accountability among researchers. Additionally, the integrity of clinical research is strengthened when data can be verified independently by regulatory bodies or other organizations through these databases.
• Discuss the role of regulatory bodies in maintaining clinical trial databases and how this impacts global harmonization efforts.
  • Regulatory bodies play a crucial role in establishing guidelines for the creation and maintenance of clinical trial databases. They ensure that data is standardized, accurate, and accessible to promote consistency across regions. By aligning their requirements with those of international partners, these organizations contribute to global harmonization efforts in the pharmaceutical and medical device industries. This cooperation allows for a more efficient drug approval process and supports collaborative research initiatives across different countries.
• Evaluate the significance of good clinical practice (GCP) in relation to the functionality of clinical trial databases.
  • Good Clinical Practice (GCP) is significant for the functionality of clinical trial databases as it establishes standards that ensure the ethical conduct of trials and the reliability of data collected. Compliance with GCP guidelines ensures that data entered into these databases is credible and represents true findings from studies. This credibility is vital for researchers analyzing aggregated data from multiple trials, as it informs regulatory decisions and guides treatment options for patients. Therefore, GCP not only influences individual trials but also enhances the overall trustworthiness of clinical trial databases in guiding future research directions.

Related terms

Clinical trial registry: A publicly accessible database that provides information on ongoing and completed clinical trials, including their purpose, recruitment status, and results.

Good Clinical Practice (GCP): An international quality standard that ensures the ethical and scientific quality of clinical trials and the integrity of data collected.

Regulatory submission: The process through which pharmaceutical or medical device companies submit clinical trial data to regulatory agencies for approval before marketing their products.