CONTRACEPTIVE CLINICAL TRIALS NETWORK, CLINICAL EVALUATION OF LARC METHODS TO DETERMINE COMPARATIVE EFFECTIVENESS, ACCEPTABILITY, AND SAFETY.

避孕临床试验网络，对 LARC 方法进行临床评估以确定比较有效性、可接受性和安全性。

• 批准号: 10412886
• 负责人: Dart Clint
• 金额: $ 235.34万
• 依托单位: HEALTH DECISIONS INC
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-23 至 2023-07-22
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10412886
• 关键词: Age; Benefits and Risks; Biological; CCL20 gene; Case Report Form; Clinical; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical Trials Network; Collection; Computers; Conduct Clinical Trials; Confidentiality of Patient Information; Contraceptive Agents; Contraceptive methods; Contractor; Contracts; Counseling; Data; Data Analyses; Data Collection; Data Management Resources; Databases; Development; Device Approval; Devices; Drug Approval; Electronic Mail; Elements; Enrollment; Evaluable Disease; Evaluation; Food and Drug Administration Drug Approval; Frequencies; Geographic Locations; Good Clinical Practice; Guidelines; Individual; Institutional Review Boards; International; Investigational New Drug Application; Manufacturer Name; Masks; Measurement; Medical; Methods; Monitor; Monitoring Clinical Trials; National Institute of Child Health and Human Development; Non obese; Obesity; Participant; Patients; Performance; Pharmaceutical Preparations; Phase; Preparation; Principal Investigator; Procedures; Protocols documentation; Randomized; Readability; Regulation; Relative Risks; Reporting; Research Personnel; Safety; Schedule; Secure; Serious Adverse Event; Services; Site; Specific qualifier value; Statistical Data Interpretation; System; Task Performances; Telephone; Travel; United States Food and Drug Administration; Update; Visit; Woman; Work; arm; base; clinical research site; comparative; comparative effectiveness; contraceptive efficacy; diaries; follow-up; innovation; laboratory facility; medication safety; meetings; member; multi-site trial; novel therapeutics; patient population; product development; protocol development; quality assurance; recruit; reproductive; research clinical testing; symposium; technical report; web site

To provide statistical and clinical coordination as well as monitoring of clinical trials, including services and support related to protocol development, data collection, database preparation, data analysis and preparation of clinical study reports of clinical trials of selected products for contraception in women. The objective of this Task Order is to obtain valid and reliable data to determine the contraceptive efficacy and safety of drugs and devices for use in obese and non-obese women of reproductive age. In addition to clinical evaluation and monitoring, the main work consists of database preparation, data analysis, preparation of the final Clinical Study Reports associated with the approved protocols, and preparation of a comprehensive Comparative Final Clinical Study Report comparing the different LARC methods evaluated in the four trials.

提供统计和临床协调以及临床试验监测，包括与方案制定、数据收集、数据库准备、数据分析和编制选定女性避孕产品临床试验的临床研究报告相关的服务和支持。 本任务指令的目的是获得有效和可靠的数据，以确定用于肥胖和非肥胖育龄妇女的药物和器械的避孕有效性和安全性。除了临床评价和监测外，主要工作还包括数据库准备、数据分析、与获批方案相关的最终临床研究报告的准备，以及比较四项试验中评价的不同LARC方法的综合比较最终临床研究报告的准备。