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class="col"><div class="content--overview"><p>欢迎来到加利福尼亚大学旧金山分校（简称“UCSF”）！在这里，医生和研究人员不断寻找新的方法来预防和治疗疾病。为此，我们的科学家采用了一种称为“临床试验”的研究方式。</p><p>开展临床试验的目的在于了解某种治疗是否有效以及是否安全。作为世界一流的研究中心，UCSF 拥有数百项临床试验。其中许多临床试验在 UCSF 医疗中心完成，该中心是美国最好的医院之一。</p><p>本网站提供有关 UCSF 正在进行中的试验的信息。您还可通过本网站联系一些招收新志愿者的试验团队。</p><p>确保患者安全是在 UCSF 开展临床试验的首要任务。我们的研究人员遵守<a href="https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics">美国国家卫生研究院 (NIH)</a> 的严格规定。您可从 <a href="https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics">NIH 网站阅读有关临床试验的详细信息</a>，了解临床试验是否适合您或您的亲人。请注意，临床试验可能仅以英语提供。</p><p>本网站包含来自 <a href="https://www.ucsf.edu/">UCSF</a>、<a href="https://clinicaltrials.gov/">ClinicalTrials.gov</a> 和其他来源的信息。</p><h2>谁可以参加</h2><ul><li>试验所需的人员将取决于试验本身及试验所尝试回答的问题。</li><li>不论年龄、性别、种族或民族，所有人都可加入临床试验。</li><li>参加的人有的是健康的，有的则患有疾病。</li></ul><h3>健康志愿者</h3><p>健康志愿者是指没有已知重大健康问题的人。</p><ul><li>一些临床试验会包含健康志愿者。</li><li>健康志愿者通常不会因加入临床试验而获得直接的健康益处。患病志愿者患病志愿者患有已知的健康问题。此类人员可加入临床试验，帮助研究人员了解或治疗该病症。</li><li>尽管此类人员可能会因加入临床研究而获得直接的健康福利，但参与的主要目的是帮助医生了解某种治疗是否有效。</li><li>一般而言，参与者会在 I 期和 II 期研究中接受新治疗。</li><li>一般而言，一些参与者会在 III 期研究中接受新治疗，而其他参与者会继续接受目前的治疗。 <ul><li>不保证参与者会接受哪种治疗，因为这是由电脑随机决定的，</li><li>目的在于公平比较新的治疗和目前的治疗。</li></ul></li></ul><h3>入选/排除标准</h3><p>必须满足相关条件才能加入研究。这些条件因研究而异。这些条件通常以年龄、性别、疾病类型、疾病进展程度、过往治疗及其他医学问题等为依据。</p><ul><li>“入选标准”是指有关加入研究的条件。 <ul><li>例如，某项临床研究可能要求仅包含 65 岁或以上的女性。</li></ul></li><li>“排除标准”是指有关阻止相关人员加入研究的条件。 <ul><li>例如，如果某人拥有特定健康问题，则他/她无法加入特定临床研究。</li></ul></li></ul><p>这些排除标准不针对个人，而是用于找到可能会获益的人员、排除可能会受到伤害的人员以及帮助研究人员找到所需的信息。</p><h2>试验流程</h2><p>临床试验是涉及治疗和人的一类研究。临床试验可帮助研究人员回答类似如下的问题：</p><ul><li>新的治疗或医疗器械是否安全？</li><li>新的治疗是否达到其目的？</li><li>新的治疗是否比目前的治疗好？</li><li>哪些患者会从新的治疗中获益最多？</li></ul><p>试验不一定会为非英语母语人员提供支持。请询问研究团队是否可以让家人或亲人陪伴您，或他们是否提供经过翻译的资料。</p><h2>合理预期/后续步骤</h2><p>如果您对参与 UCSF 临床试验感兴趣，您可以：</p><ul><li>在网站中搜索适用于您的试验。搜索试验时包含您的语言，例如“糖尿病普通话”</li><li>通过本网站告知研究人员您感兴趣。</li><li>研究人员会使用您提供的联系信息与您联系。</li><li>研究人员会告知您关于研究的详细信息。</li><li>您可以向研究人员提出任何问题。</li><li>研究人员会问您一些问题，了解您是否“符合资格”，即您是否为该研究所需的参与者。</li><li>如果您符合资格且仍然想要加入，研究人员会为您报名。</li><li>您需要查看并签署知情同意书。 <ul><li>知情同意书上会列出您的权利。</li><li>知情同意书上会列出可能的益处和伤害。</li><li>知情同意书上会列出您需要在研究中完成的事项。</li><li>这通常包括前往 UCSF 接受治疗和检测。</li><li>就诊和检测的次数及类型因研究而异。</li></ul></li><li>您拥有明确的权利，并可随时出于任何理由停止参与研究。详细了解您的权利。</li></ul><h2>有关临床试验的详细信息</h2><p>临床试验按“期”分阶段完成。在每一期，研究人员都会尝试回答一个不同的问题。每一期都需要一组不同的参与者，因此，一名参与者一次仅可加入一项试验。</p><ul><li>I 期：是否安全？ <ul><li>这是第一次针对患者测试新的治疗，因此参与者不会太多。</li><li>主要目标在于了解治疗是否安全。</li><li>I 期研究的参与者可以是健康个体，也可以是患病个体。</li></ul></li><li>II 期：是否有效？ <ul><li>一旦确定治疗是安全的，即可开展 II 期研究来了解治疗是否有效。</li><li>II 期研究的参与者通常多于 I 期研究的参与者。</li></ul></li><li>III 期：是否比目前的治疗好？ <ul><li>III 期研究将新的治疗与目前的治疗对比，了解哪种治疗更安全及更有效。</li><li>III 期研究拥有较多参与者，有时可能达到数千人。</li><li>III 期研究表明治疗有效且安全后，美国食品药品监督管理局 (FDA) 会对其进行审核并批准。</li></ul></li><li>IV 期：还会发生什么？ <ul><li>治疗通过 FDA 批准并开始使用后，研究人员可能会开展 IV 期研究。</li><li>IV 期研究的目的在于了解该治疗是否对其他病症有用或是否会出现长期问题。</li></ul></li></ul><h3>主要有两种类型的临床研究：</h3><ul><li>一种是观察性研究，指研究人员不采取任何与研究相关的医疗行为。如果需要，患者根据常规临床方案接受治疗。参与这些研究的人员会在一段时间内接受监测，研究团队会收集关于参与者的数据并进行研究。</li><li>另一种是介入性临床试验，指研究人员采取行动来预防、更好地了解或治疗某种疾病。他们会测试新药物或其他治疗的安全性和有效性。介入性临床试验遵守严格的规定来保护患者。</li></ul><p>如需详细了解临床试验的一般信息，请参阅 UCSF 和美国国家卫生研究院的这些页面。</p></div> </div> </div> <div class="row"><div class="col-sm-12"> </div></div></div> </main><footer class="mt-auto" role="contentinfo" data-nosnippet><div id="ucsf--footer--body"><div class="container" data-nosnippet><div 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