Pharmaceuticals and Cancer

制药与癌症

• 批准号: 8306337
• 负责人: LAUREL A HABEL
• 金额: $ 31.55万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-05-14 至 2014-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8306337
• 关键词: Adult; Adverse drug effect; Adverse effects; Animals; Antineoplastic Agents; Calendar; California; Carcinogens; Caring; Chemopreventive Agent; Child; Computerized Medical Record; Computers; Data; Databases; Diagnosis; Drug Prescriptions; Electronics; Ensure; Exposure to; Funding; Generations; Health; Health Planning; Healthcare; Hospitalization; Human; Institute of Medicine (U.S.); Investigation; Laboratories; Link; Low Prevalence; Malignant Neoplasms; Medical; Outpatients; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacy facility; Positioning Attribute; Process; Progress Reports; Publications; Publishing; Records; Reporting; Request for Applications; Resources; Risk; Safety; Screening procedure; Signal Transduction; Staging; Surveillance Program; System; Testing; United States Food and Drug Administration; Visit; Work; World War II; base; cancer diagnosis; cancer risk; carcinogenicity; cost; design; drug development; drug market; member; neoplasm registry; post-market; programs; response; safety study

DESCRIPTION (provided by applicant): A growing proportion of children and adults take medication regularly, yet relatively few drugs have undergone significant post-marketing surveillance for adverse effects, including elevated cancer rates. The main objective of our originally funded proposal was to identify commonly prescribed drugs that are associated with lower or higher rates of cancer and examine whether these associations deserved further study. The study was conducted within Kaiser Permanente of Northern California (KPNC), a prepaid, integrated health plan with over 3.2 million currently active members. We conducted surveillance analyses (i.e., hypothesis generating) of the 230 most commonly prescribed drugs (at least 30,000 recipients from 1994-2003) with a special focus on the 115 drugs not examined in our previous program of surveillance of drugs for carcinogenicity, as well as several more in-depth analyses of drug-cancer associations (i.e., hypothesis testing). In this Renewal application, we are requesting funding to continue our surveillance of commonly prescribed drugs for carcinogenicity, as well as to examine selected drug-cancer associations of potential importance. This Renewal application builds on a drug surveillance program conducted within KPNC since the late 1970s. Specifically, we propose to: 1) Continue surveillance of commonly used prescription drugs for possible carcinogenic effects (i.e., hypothesis generation) among KPNC members with computer-stored pharmacy records since 1994, and 2) Conduct studies of selected drug-cancer associations found in the above screening analyses or from reports of human or animal studies (i.e., hypothesis testing). During the calendar period of the Renewal over two million of our members will be prescribed one or more drugs and approximately 18,000 members will be diagnosed with cancer per year for a total of approximately 320,000 cancers diagnosed among members during the period of study (1994-2013). The KPNC membership and databases continue to provide a unique resource for cost-efficient surveillance of a large number of prescription drugs for possible carcinogenic effects and for more in-depth studies of specific drug-cancer associations. The membership is large, stable, ethnically diverse, and receives virtually all of its health care from the pre-paid, integrated medical care program. Hard copy and electronic medical records are available with information on prescribed medications, cancer diagnoses, laboratory tests, and outpatient visits and hospitalizations. PUBLIC HEALTH RELEVANCE: New drug development continues at a rapid pace and a growing proportion of children and adults in the US take one or more medications on a regular basis. Yet despite growing public and scientific concern about potential health risks, there has been relatively little surveillance of commonly prescribed drugs for adverse effects, including elevated cancer rates. The Kaiser Permanente of Northern California surveillance program has been designed to detect signals of potential cancer risk associated with commonly prescribed drugs and to conduct more in-depth investigations of specific medications. Our program provides a valuable mechanism to identify early signs of possible carcinogenic effects of the most commonly used medications or reassurance as to their safety in this regard.

描述（由申请人提供）：越来越多的儿童和成人定期服用药物，但相对较少的药物经历了显着的上市后不良反应监测，包括癌症发病率升高。我们最初资助的提案的主要目标是确定与较低或较高癌症发病率相关的常用处方药，并检查这些关联是否值得进一步研究。这项研究是在北方加州的Kaiser Permanente（KPNC）内进行的，这是一个预付费的综合健康计划，目前有320多万活跃成员。我们进行了监测分析（即，假设生成）的230种最常用的处方药（从1994-2003年至少30，000名接受者），特别关注在我们以前的致癌性药物监测计划中未检查的115种药物，以及对药物-癌症关联的几种更深入的分析（即，假设检验）。在这次更新申请中，我们要求提供资金，以继续监测常用处方药的致癌性，并检查选定的具有潜在重要性的药物与癌症的关联。该更新申请建立在KPNC自20世纪70年代末以来进行的药物监测计划的基础上。具体而言，我们建议：1）继续监测常用处方药的可能致癌作用（即，假设生成），以及2）对在上述筛选分析中或从人类或动物研究报告中发现的选定药物-癌症关联进行研究（即，假设检验）。在续约的日历期间，我们将为超过200万名会员开具一种或多种药物，每年约有18，000名会员被诊断患有癌症，研究期间（1994-2013），会员中诊断出的癌症总数约为320，000例。KPNC的成员资格和数据库继续提供一个独特的资源，用于对大量处方药的可能致癌作用进行成本效益高的监测，并对特定药物与癌症的关联进行更深入的研究。会员人数众多，稳定，种族多样，几乎所有的医疗保健都来自预付费综合医疗保健计划。提供硬拷贝和电子病历，其中包括处方药物、癌症诊断、实验室检查、门诊和住院信息。公共卫生相关性：新药开发继续以快速的步伐和越来越多的比例在美国的儿童和成人采取一种或多种药物定期。然而，尽管公众和科学界对潜在的健康风险越来越关注，但对常见处方药的不良反应（包括癌症发病率升高）的监测相对较少。北方加州Kaiser Permanente监测项目旨在检测与常用处方药相关的潜在癌症风险信号，并对特定药物进行更深入的调查。我们的计划提供了一个有价值的机制，以识别最常用药物可能致癌作用的早期迹象或保证其在这方面的安全性。