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利用外部来源的数据和从先前完成的研究中收集和分析的数据,使用建模和模拟和其他方法来支持以儿科为重点的监管承诺
Nancy A Sherman1, Kevin D Wolter2, Elena Soto3
1Internal Medicine Clinical Development, Pfizer Inc., 66 Hudson Blvd., 13Th Floor, New York, NY, USA. nancy.sherman@pfizer.com.
Therapeutic innovation & regulatory science
|January 21, 2026
概括
利用外部数据和先前的内部研究可以克服临床试验招聘的挑战. 该战略补充了数据缺口,增强了监管提交,以成功完成试验.
科学领域:
- 临床研究是临床研究.
- 监管事务 监管事务
- 数据科学是数据科学.
背景情况:
- 临床试验面临着许多挑战,包括罕见疾病,有限的地点,复杂的程序,以及儿科研究中的父母同意问题.
- 这些困难可能会阻碍监管承诺的成功及及时实现.
- 补充试验数据的策略对于满足监管要求至关重要.
研究的目的:
- 审查成功纳入外部数据的临床试验和监管承诺.
- 评估在监管提交中使用以前完成的内部研究数据的情况.
- 突出这些策略在克服常见临床试验障碍方面的潜力.
主要方法:
- 对临床试验和监管承诺进行了审查.
- 确定了使用外部来源数据的实例.
- 分析了之前完成的内部研究数据的包含.
主要成果:
- 外部来源的数据和完成的内部研究的数据可以补充临床试验数据.
- 这种方法可以增加监管提交的可靠性.
- 该战略有效地解决了招聘障碍和其他挑战造成的差距.
结论:
- 利用外部数据和先前的内部研究数据是一个有价值的策略.
- 这种方法可以显著提高监管提交,特别是当面临招聘困难时.
- 建议提高对这些数据补充技术的认识和采用.
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