Challenges to Recruiting Men on Active Surveillance for Prostate Cancer in Clinical Chemoprevention Trials.
Challenges to Recruiting Men on Active Surveillance for Prostate Cancer in Clinical Chemoprevention Trials.
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患者和公众参与临床试验对于发现和测试预防或治疗疾病（包括癌症）的新药的有效性和安全性至关重要。尽管据估计，>70%的美国人倾向于参加临床试验，但参加临床试验的成年癌症患者不到5%。我们和其他人已经观察到临床试验中招募和累积的几个挑战。本文的目的是回顾我们在确定方案和患者水平挑战方面的经验，以招募前列腺癌患者参加在综合癌症中心进行的临床癌症化学预防试验。我们在这里报告，我们已经采取了克服这些挑战，招募临床试验受试者的当代策略。这些战略可以更好地使研究团队选择，重点和投资于最有成效和效率的战略，以招募目标人群，以实现招聘目标。临床试验在循证医学中发挥着至关重要的作用，当严格的科学方法被用来发现和测试新药的有效性和安全性，以预防或治疗疾病，包括癌症。因此，参与临床试验成为成功完成这些试验的关键。尽管据估计，>70%的美国人倾向于参加临床试验，但参加临床试验的成年癌症患者不到5%。因此，倾向于参加临床试验的人与实际参加临床试验的人之间存在很大差距。与针对积极监测（AS）的前列腺癌（PCa）男性的试验一样，目标人群大多超过50岁，其他人在临床试验中观察到招募和累积的几个挑战。参与率目前无法获得男性的初级和二级化学预防试验。此外，由于不可预见的环境因素，如大流行或其他自然紧急情况，可能严重影响经济、个人财产、旅行和研究相关程序的人与人之间的接触，因此需要不断识别这些挑战，并确定化学预防试验中招募障碍的解决方案，以确保及时完成早期试验。最近关于大流行对临床试验招募的影响的研究表明，与癌症治疗试验相比，癌症预防试验受到的负面影响相对更大。本手稿的目的是回顾我们在综合癌症中心（CCC）进行的这项癌症化学预防试验中持续评价方案和招募AS受试者治疗PCa的患者水平挑战的经验，并报告我们在这项试验中继续招募受试者的当代策略。我们提供了当前试验的数据作为示例，同时讨论了改善整体临床试验招募的未来策略。这些策略可以为当代癌症化学预防试验的未来设计提供信息，此外，还可以更好地选择，重点关注和投资于招募目标人群最有效和最有效的策略。
Patients and public participation in clinical trials is critical to discovering and testing the effectiveness and safety of new drugs to prevent or cure diseases, including cancer. Although it is estimated that >70% of Americans are inclined to participate in clinical trials, less than 5% of adult cancer patients participate in clinical trials. We and others have observed several challenges with recruitment and accrual in clinical trials. The goal of this manuscript is to review our experience in determining protocol and patient level challenges to recruiting prostate cancer patients in clinical cancer chemoprevention trials conducted in a Comprehensive Cancer Center. We report here, contemporary strategies that we have adopted to overcome these challenges to recruit subjects in clinical trials. These strategies can better enable research teams select, focus and invest in strategies that are the most productive and efficient for recruiting target populations to meet recruitment goals. Clinical trials play a critical role in evidence-based medicine, when rigorous scientific methodology is utilized to discover and test the effectiveness and safety of new drugs to prevent or cure diseases, including cancer. Participation in clinical trials thus becomes key to successful completion of these trials. Although it is estimated that >70% of Americans are inclined to participate in clinical trials, less than 5% of adult cancer patients participate in clinical trials. There is thus a large gap between those inclined to participate in clinical trials and actual participation in clinical trials. As with trials targeting men with prostate cancer (PCa) on active surveillance (AS), where the target population is mostly over 50 years of age, others have observed several challenges with recruitment and accrual in clinical trials. The participation rate is currently unavailable for men on primary and secondary chemoprevention trials. Additionally, with unanticipated environmental factors such as a pandemic or other natural emergencies that may severely impact the economy, personal property, travel and person-to person contact for study-related procedures, there is a need to continuously identify these challenges and determine solutions to recruitment barriers in chemoprevention trials to ensure timely completion of early phase trials. Recent studies regarding the impact of the pandemic on clinical trial recruitment have shown that cancer prevention trials were relatively more negatively impacted compared to cancer treatment trials. The goal of this manuscript is to review our experience in continuously evaluating the protocol and patient level challenges to recruiting subjects on AS for PCa in this cancer chemoprevention trial conducted at the Comprehensive Cancer Center (CCC) and report the contemporary strategies that we are utilizing to continue to recruit subjects in this trial. We provide data from our current trial as an example while discussing future strategies to improve overall clinical trial recruitment. These strategies can inform future design of contemporary cancer chemoprevention trials and, additionally, better select, focus and invest in strategies that are the most productive and efficient for recruiting target populations.
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