患有前列腺癌的退伍军人在科学上得不到充分的服务吗？描述在退伍军人事务部进行前列腺癌临床试验的途径

IF 2.4 3区医学 Q3 ONCOLOGY

Urologic Oncology-seminars and Original Investigations Pub Date : 2025-03-01 DOI:10.1016/j.urolonc.2024.12.028

Madison Krischak, David Elliott, Zach Landis-Lewis, Patrick Lewicki, Gretchen Piatt, Todd Morgan, Geoffrey Barnes, Alex Bryant, Megan Caram, Phoebe Tsao, Molly Harrod, Ted Skolarus, Anne Sales, Kristian Stensland

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引用次数: 0

摘要

临床试验促进了科学的发展，提供了创新的护理，有时这是癌症患者唯一的治疗选择。一些群体没有获得临床试验的机会，使他们无法获得参与试验的好处，并且可能被认为是“科学服务不足”。具体到患有前列腺癌的退伍军人，目前尚不清楚退伍军人事务部提供前列腺癌临床试验的频率和地点，以及哪些人可能在科学上得不到充分的服务。描述这些差距可以确定改善退伍军人获得癌症临床试验的机会，确保退伍军人获得临床试验登记的好处。为了了解准入方面的差距，我们评估了在ClinicalTrials.gov上注册的前列腺癌临床试验中VA站点的纳入情况。方法在2024年3月，我们使用Python脚本识别了2007年1月1日之后在ClinicalTrials.gov上注册的所有2-3期前列腺癌临床试验记录，并提取了试验站点信息。使用自定义算法来识别记录在ClinicalTrials.gov上的VA站点。我们确定了在每个VA进行的独特试验的数量，按试验阶段和总体试验状态分组。我们从VA目录（va.gov/directory）手动识别VA医院的总数，按唯一地址对医院进行分组，并手动删除重复的医院。然后我们描述了至少有1个临床试验的VA站点的比例，以及至少有1个VA站点的试验的比例。通过描述每个普查区至少有1项前列腺癌试验的VA设施的比例，我们进一步确定了试验可获得性的地理差异。结果在1884项注册的2期或3期前列腺癌临床试验中，118项（6%）包括至少一个VA位点。在353项3期试验中，55项（16%）包括至少1个VA位点。在159家VA机构中，66家（42%）至少进行了一项2期或3期前列腺癌临床试验，58家（36%）至少进行了一项3期试验。截至2024年3月，有53个VA站点（33%）正在进行3期前列腺癌临床试验，60个（38%）正在进行2期或3期前列腺癌临床试验，8个站点（5%）正在进行10项前列腺癌临床试验。在人口普查区内的退伍军人管理局站点，前列腺癌试验的可用性从新英格兰人口普查区10个退伍军人管理局站点中的3个到太平洋人口普查区19个退伍军人管理局站点中的10个不等。在退伍军人事务部接受治疗的退伍军人只有6%的前列腺癌临床试验机会。此外，只有不到一半的退伍军人医院是至少一项前列腺癌临床试验的场所，只有三分之一的医院进行了前列腺癌三期临床试验。在VA试验可用性方面存在一些地理差异，太平洋地区VA设施提供试验的比例高于新英格兰或中大西洋地区。这些研究结果表明，退伍军人目前在退伍军人事务部内的前列腺癌临床试验企业可能在科学上服务不足。确定策略以改善患有前列腺癌的退伍军人参与临床试验的机会，最好是在退伍军人事务部内，这应该是一个优先事项。这些策略也可能适用于改善VA内外其他癌症试验的登记情况。

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ARE VETERANS WITH PROSTATE CANCER SCIENTIFICALLY UNDERSERVED? DESCRIBING ACCESS TO PROSTATE CANCER CLINICAL TRIALS IN THE VA

Introduction

Clinical trials advance science and provide innovative care that is sometimes the only treatment option for people with cancer. Some groups do not have access to clinical trials, excluding them from the benefits of trial participation, and could be considered “scientifically underserved”. Specific to Veterans with prostate cancer, it is unclear how frequently and where prostate cancer clinical trials are offered within the VA, and who may be scientifically underserved. Describing these gaps could identify opportunities for improving Veteran access to cancer clinical trials, ensuring Veterans are afforded the benefits of clinical trial enrollment. To understand gaps in access, we assessed VA site inclusion in prostate cancer clinical trials registered on ClinicalTrials.gov.

Methods

In March 2024, using a Python script, we identified all phase 2-3 prostate cancer clinical trial records registered on ClinicalTrials.gov after January 1, 2007, and extracted trial site information. A custom algorithm was used to identify VA sites recorded on ClinicalTrials.gov. We identified the number of unique trials hosted at each VA grouped by trial phase and overall trial status. We manually identified the total number of VA hospitals from the VA directory (va.gov/directory), grouping hospitals by unique address and manually removing duplicates. We then described the proportion of VA sites hosting at least 1 clinical trial, and the proportion of trials with at least 1 VA site. We further identified geographic variation in trial availability by describing the proportion of VA facilities in each census division with at least 1 prostate cancer trial.

Results

Of 1,884 registered phase 2 or 3 prostate cancer clinical trials, 118 (6%) included at least one VA site. Of 353 phase 3 trials, 55 (16%) included at least 1 VA site. Of 159 identified VA facilities, 66 (42%) have had at least one phase 2 or 3 prostate cancer clinical trial, while 58 (36%) have had at least one phase 3 trial. As of March 2024, there were 53 VA sites (33%) with a currently active phase 3 prostate cancer clinical trial, 60 (38%) with an active phase 2 or 3 prostate cancer clinical trial, and 8 sites (5%) with >10 currently active prostate cancer clinical trials. Availability of prostate cancer trials at VA sites within census divisions ranged from 3 of 10 VA facilities in the New England census division to 10 of 19 VA facilities in the Pacific census division.

Conclusions

Veterans treated at VA facilities have access to only 6% of prostate cancer clinical trials. Further, less than half of VA hospitals are sites for at least one prostate cancer clinical trial, and only a third have had a phase 3 prostate cancer clinical trial. There was some geographic variation in VA trial availability, with a higher proportion of Pacific division VA facilities offering trials than New England or Middle Atlantic divisions. These findings suggest Veterans may be scientifically underserved by the current prostate cancer clinical trials enterprise within the VA. Identifying strategies to improve access for Veterans with prostate cancer to the benefits of participating in clinical trials, ideally within the VA, should be a priority. These strategies would also likely be applicable in improving enrollment to other cancer trials in and out of the VA.

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来源期刊

Urologic Oncology-seminars and Original Investigations 医学-泌尿学与肾脏学

CiteScore

4.80

自引率

3.70%

发文量

297

审稿时长

7.6 weeks

期刊介绍： Urologic Oncology: Seminars and Original Investigations is the official journal of the Society of Urologic Oncology. The journal publishes practical, timely, and relevant clinical and basic science research articles which address any aspect of urologic oncology. Each issue comprises original research, news and topics, survey articles providing short commentaries on other important articles in the urologic oncology literature, and reviews including an in-depth Seminar examining a specific clinical dilemma. The journal periodically publishes supplement issues devoted to areas of current interest to the urologic oncology community. Articles published are of interest to researchers and the clinicians involved in the practice of urologic oncology including urologists, oncologists, and radiologists.