Pilot Studies for the Active Comparator Osteoporosis Large Simple Trial (ATLAST)

描述（由申请人提供）：尽管批准用于预防和治疗骨质疏松症的治疗药物数量持续增加，但对成熟和较新的抗骨质疏松症药物的骨折风险降低和长期安全性知之甚少。大型简单临床试验（LST），也被称为实用性试验，包括随机化，但使用最低限度的纳入/排除标准，允许研究“真实的"患者人群，这些人群通常被排除在传统的随机对照试验之外。活性对照药物骨质疏松症大型简单试验（ATLAST）将是随机分配至FDA批准的抗骨质疏松治疗的患者的LST，该试验将研究不同社区人群的比较有效性和安全性结局。作为一项研究设计效率，ATLAST将通过与Medicare医疗索赔和Part D处方药数据的联系，包括对患者结局的纵向监测。为了促进未来ATLAST研究的成功实施，我们提出了一个试点和可行性测试，重点是开发和完善基础设施和患者招募过程。我们建议开发和测试使用与Mytrus合作开发的基于网络的技术的可行性，该技术将用于忙碌社区医生办公室。这项试点补助金的具体目标是：SA 1）开发完成ATLAST所需的新材料和修改现有材料，包括：a）定制和试点测试在安全的基于网络的数据收集平台上运行的交互式登记、知情同意和随机化软件，B）获得链接到Medicare数据所需的同意和受保护的健康信息，以及c）开发基于患者的骨质疏松症结果随访调查; SA 2）完成小型临床试验（即试点测试）的过程和方法开发的ATLAST研究的合作伙伴关系与样本的六个地理不同的社区一般做法，以测试接受和可行性的知情同意过程，随机化，随访调查，并在36名患者中创建Medicare查找器文件。从ATLAST试点研究中吸取的经验教训将促进ATLAST的全面推广，这将在以社区为基础的LST和骨质疏松症比较有效性研究中取得重大进展。

DESCRIPTION (provided by applicant): Despite continued increases in the number of approved therapeutics for prevention and treatment of osteoporosis, very little is known about the comparative fracture risk reduction and long-term safety of well-established and newer anti-osteoporosis drugs. Large simple clinical trials (LSTs), also known as pragmatic trials, include randomization but use minimal inclusion/exclusion criteria, allowing for study of 'real world' patient populations who are often excluded in traditional randomized controlled trials. The Active Comparator Osteoporosis Large Simple Trial (ATLAST) will be an LST of patients randomized to FDA approved anti-osteoporosis therapies that will study comparative effectiveness and safety outcomes in diverse community-based populations. As a study design efficiency, ATLAST will include the longitudinal surveillance of patient outcomes through linkage with Medicare medical claims and Part D prescription drug data. To facilitate the successful implementation of a future ATLAST study, we propose a pilot and feasibility testing that focuses on developing and refining the infrastructure and patient enrollment process. We propose to develop and test feasibility of using web- based technology developed in collaboration with Mytrus to be used in busy community physician offices. The specific aims (SAs) of this pilot grant are: SA 1) To develop new and to modify existing materials necessary for the completion of ATLAST including: a) customizing and pilot testing of interactive enrollment, informed consent, and randomization software running on a secure web-based data collection platform, b) obtaining consent and protected health information needed for linkage to Medicare data, and c) developing a patient-based osteoporosis outcomes follow-up survey; SA 2) To complete a mini-clinical trial (i.e. pilot test) of the processes and methods developed for the ATLAST study in partnerships with a sample of six geographically diverse community general practices to test the acceptance and feasibility of informed consent processes, randomization, follow-up surveys, and creation of Medicare finder files in 36 patients. Lessons learned from the ATLAST pilot study will facilitate the full- scale rollout of ATLAST that will provide major advances in community-based LSTs and osteoporosis comparative effectiveness research.