数据质量的改善可以提高效率并降低开发成本:药量计CRO的观点
Amparo de la Peña1, Jill Fiedler-Kelly2, Rebecca L Humphrey2
1Simulations Plus, Inc., Research Triangle Park, PO Box 12317, Durham, North Carolina, 27709, USA. amparo.delapena@simulations-plus.com.
The AAPS journal
|December 5, 2025
概括
高质量的数据对于有效的药物开发至关重要. 合同研究组织 (CROs) 由于质量问题而花费大量时间和资源来清理赞助商数据,强调需要改进数据管理实践.
科学领域:
- 药理计量和药物开发研究
- 临床研究中的数据管理
背景情况:
- 药物开发是一个漫长而昂贵的过程,严重依赖高质量的数据.
- 合同研究组织 (CRO) 在管理和分析药物赞助商的数据方面发挥着至关重要的作用.
- 基于模型的药物开发 (MIDD) 需要强大而可靠的数据集来准确预测和决策.
研究的目的:
- 评估数据管理活动对模型信息化药物开发 (MIDD) 成果的影响.
- 评估CRO在评估赞助商提供的数据质量的基础经验.
- 为了确定与准备分析准备数据集相关的时间和成本.
主要方法:
- 在提供数据管理服务的32家公司中,向44名药物测量专业人员分发了一项调查.
- 匿名调查包括11个问题 (9个选择题,2个开放题),重点是数据质量评估和数据集准备.
- 分析了17个参与CRO的答案,以确定共同的数据质量挑战和时间支出.
主要成果:
- 65%的CRO报告说,由于格式问题,缺少数据和不一致性,赞助商提供的数据很少可用 (<10%).
- 超过50%的人认为缺乏清晰的数据定义和规范是数据质量差的主要原因.
- 每个数据集的数据清理成本从750美元到6000美元不等,需要3到24小时的编程时间.
结论:
- CROs投入了大量的时间和财务资源来纠正质量差的赞助商数据.
- 虽然自动化数据质量检查提高了效率,但它们无法完全解决所有数据完整性问题.
- 改善沟通,协作和系统方法,包括自动化和人工智能,对于提高药物开发数据质量至关重要.
相关概念视频
01:12Analysis of Population Pharmacokinetic Data
657
Analysis of population pharmacokinetic data involves studying the behavior of drugs within diverse populations to understand their pharmacokinetic parameters. Traditional pharmacokinetic methods typically involve collecting samples from a few individuals and estimating these parameters. While these methods are commonly used, they have limitations in capturing the variability in drug response among individuals or heterogeneous populations. Population pharmacokinetics is employed to address these...
657
01:20Measurement of Bioavailability: Pharmacodynamic Methods
217
Pharmacodynamic methods provide insights into a drug's effects on physiological processes over time and play a crucial role in understanding bioavailability and therapeutic efficacy. These methods can be broadly classified into acute pharmacological and therapeutic response approaches, each with distinct mechanisms and applications.The acute pharmacological response method directly correlates a drug's physiological effects, such as ECG or pupil diameter changes, to its time course in the body.
217
00:59Model-Independent Approaches for Pharmacokinetic Data: Noncompartmental Analysis
297
Noncompartmental analyses offer an alternative method for describing drug pharmacokinetics without relying on a specific compartmental model. In this approach, the drug's pharmacokinetics are assumed to be linear, with the terminal phase log-linear. This assumption allows for simplified analysis and interpretation of the drug's behavior in the body.
One important characteristic of noncompartmental analyses is that drug exposure increases proportionally with increasing doses. This...
One important characteristic of noncompartmental analyses is that drug exposure increases proportionally with increasing doses. This...
297
01:01Dosage Regimens: Partial Pharmacokinetic Parameters
135
It is not uncommon for complete drug pharmacokinetic profiles to remain elusive in pharmacokinetics. This necessitates certain educated assumptions by pharmacokineticists to determine appropriate dosage regimens without comprehensive pharmacokinetic data from animal or human studies. One prevalent assumption is setting the bioavailability factor, denoted as F, to 1 or 100%. This assumption caters to the scenario where a drug doesn't achieve full systemic absorption, resulting in the patient...
135
01:14Analysis Methods of Pharmacokinetic Data: Model and Model-Independent Approaches
463
Drug disposition in the body is a complex process and can be studied using two major approaches: the model and the model-independent approaches.
The model approach uses mathematical models to describe changes in drug concentration over time. Pharmacokinetic models help characterize drug behavior in patients, predict drug concentration in the body fluids, calculate optimum dosage regimens, and evaluate the risk of toxicity. However, ensuring that the model fits the experimental data accurately...
The model approach uses mathematical models to describe changes in drug concentration over time. Pharmacokinetic models help characterize drug behavior in patients, predict drug concentration in the body fluids, calculate optimum dosage regimens, and evaluate the risk of toxicity. However, ensuring that the model fits the experimental data accurately...
463
01:16Bioequivalence Data: Statistical Interpretation
183
Body:The statistical interpretation of bioequivalence data is a significant aspect of pharmaceutical research. Bioequivalence refers to the absence of any significant difference in the rate and extent to which the active ingredient in pharmaceutical products becomes available at the site of drug action when administered at the same molar dose under similar conditions. This helps determine if different drug products have similar absorption rates, ensuring their interchangeability.Statistical...
183