Halaseh Sattam A, Al-Karadsheh Amro, Mukherji Deborah, Alhjahaja Abdelrahman, Farkouh Ala'a, Al-Ibraheem Akram, Gheida Ibrahim Abu, Al-Khateeb Sultan, Al-Shamsi Humaid, Shahait Mohammed
Urology Department, Torbay Hospital, Torbay and South Devon NHS Foundation Trust, Newton Rd, Torquay TQ2 7AA, UK.
General Medicine, Lincoln County Hospital, United Lincolnshire Hospitals NHS Trust, Greetwell Rd, Lincoln LN2 5QY, UK.
Ecancermedicalscience. 2023 Nov 13;17:1629. doi: 10.3332/ecancer.2023.1629. eCollection 2023.
Prostate cancer is the second most common form of cancer and a leading cause of cancer-related death in men. In an era of evidence-based medicine, clinical trials play a critical role, and adherence to best practices is crucial in managing complicated and non-communicable diseases, such as prostate cancer. For this reason, extrapolating research conducted in high-income countries (HICs) to low-middle-income countries (LMICs) may lead to incorrect findings or treatment plans for patients in these areas. Unfortunately, clinical trials in LMICs face several challenges in terms of design, funding and recruitment. This study aimed to examine clinical trials on prostate cancer in LMICs, including the scope of these trials, the type of interventions being tested and funding sources.
A search of the Cochrane Library Controlled Trials Registry was conducted between January 2010 and June 2021 using keywords including: 'prostate cancer', 'prostate adenocarcinoma' and 'prostate tumour'). The trials were classified into either HICs or LMICs based on the World Bank Atlas classification. A descriptive analysis was performed to determine the characteristics of the trials.
A total of 3,455 clinical trials for prostate cancer have been conducted globally, with 542 (15.68%) conducted LMICs. Most of these trials (89%) were registered in upper-middle-income countries, with none being conducted in low-income countries. The majority of trials were prospective studies (98.1%), with 65.2% being randomised and 57% being phase III. Of the trials, 48.4% aimed to recruit fewer than 500 participants. The main source of funding was pharmaceutical companies in 78.1% of the cases, followed by institutional funds (16.1%) and public funds (5.8%). At the time of the search query, 74.6% of the trials were inactive, with 37% completed, 5% terminated due to insufficient funding and 75% terminated due to medical inefficacy or poor accrual. The majority of trials (88.2%) were interventional, with only 6% focusing on screening and prevention, and 2% designed for palliative care.
This study sheds light on the challenges faced in conducting clinical trials for prostate cancer in LMICs. The findings underline the need for improved support from international organisations and pharmaceutical companies to bridge the gaps in prostate cancer research and facilitate collaboration between researchers in LMICs and other countries.
前列腺癌是男性中第二常见的癌症形式，也是癌症相关死亡的主要原因。在循证医学时代，临床试验发挥着关键作用，在管理诸如前列腺癌等复杂的非传染性疾病时遵循最佳实践至关重要。因此，将在高收入国家（HICs）开展的研究推断至低中收入国家（LMICs）可能会导致这些地区患者的研究结果或治疗方案出现错误。不幸的是，低中收入国家的临床试验在设计、资金和招募方面面临诸多挑战。本研究旨在考察低中收入国家前列腺癌的临床试验，包括这些试验的范围、所测试的干预措施类型以及资金来源。
于2010年1月至2021年6月期间在Cochrane图书馆对照试验注册库进行检索，使用的关键词包括：“前列腺癌”、“前列腺腺癌”和“前列腺肿瘤”）。根据世界银行地图集分类，将试验分为高收入国家或低中收入国家。进行描述性分析以确定试验的特征。
全球共开展了3455项前列腺癌临床试验，其中542项（15.68%）在低中收入国家进行。这些试验大多数（89%）在中高收入国家注册，低收入国家没有进行试验。大多数试验为前瞻性研究（98.1%），其中65.2%为随机试验，57%为III期试验。在这些试验中，48.4%的试验目标招募人数少于500人。资金的主要来源在78.1%的情况下是制药公司，其次是机构资金（16.1%）和公共资金（5.8%）。在检索查询时，74.6%的试验处于非活动状态，37%已完成，5%因资金不足而终止，75%因医学无效或招募不佳而终止。大多数试验（88.2%）为干预性试验，只有6%关注筛查和预防，2%专为姑息治疗设计。
本研究揭示了低中收入国家在开展前列腺癌临床试验时面临的挑战。研究结果强调需要国际组织和制药公司提供更好的支持，以弥合前列腺癌研究的差距，并促进低中收入国家与其他国家研究人员之间的合作。
