印度癌症临床试验概况--对印度临床试验登记处的全面分析

IF 5 Q1 HEALTH CARE SCIENCES & SERVICES The Lancet regional health. Southeast Asia Pub Date : 2024-05-01 DOI:10.1016/j.lansea.2023.100323

Peng Gao , Justin Chen , Zhongyu Hong , Marcus Choi , Allison Morgan , Anton Petushkov , Rajuli Lall , Chao Liu , Vamshi K. Muddu , Venugopal Arroju , Chinnababu Sunkavalli , Geoffrey Kim , Bobby Y. Reddy

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引用次数: 0

摘要

背景癌症是印度发病和死亡的主要原因之一。临床试验是推动癌症治疗、诊断和预防创新的关键。本研究旨在通过分析在印度临床试验注册中心（CTRI）注册的临床试验，描绘印度癌症临床试验不断发展的状况。然后，我们整理并分析了CTRI的公开信息（癌症亚型、试验类型、治疗目的、干预类型、赞助商类型、招募国家），并使用描述性统计来说明总体趋势和逐年趋势。研究结果我们共确定了1988项癌症试验，其中大部分试验侧重于治疗癌症（63%），其余试验旨在优化手术操作（19%）、减轻治疗相关毒性（10.6%）或治疗癌症相关症状（7.8%）。在以治疗癌症为目的的试验中，我们发现大多数试验的研究对象是实体瘤而非血液恶性肿瘤，最主要的癌症亚型是乳腺癌（17%）、头颈癌（9.8%）、肺癌（9.6%）和宫颈癌（6.6%）。在我们的分析中，针对特定癌症亚型开展的试验数量与印度相应癌症亚型的发病率、死亡率和5年患病率总体相关；但是，与疾病负担相比，头颈癌和宫颈癌的试验数量偏低。最常见的干预类型是研究药物。最常见的赞助商类型是全球制药业（26%）以及研究机构和医院（26%）。尽管癌症负担相对较重，但印度东北部各邦的癌症试验却很有限。释义印度的癌症临床研究迫切需要更好地与该国的医疗保健需求和疾病负担保持一致，重点关注流行性和致命性癌症，同时确保各地区和服务不足人群都能获得临床试验。

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Landscape of cancer clinical trials in India – a comprehensive analysis of the Clinical Trial Registry-India

Background

Cancer is one of the leading causes of morbidity and mortality in India. Clinical trials are critical for driving innovation in cancer therapy, diagnosis, and prevention. This study aims to depict the evolving landscape of cancer clinical trials in India by analysing the clinical trials registered in Clinical Trial Registry-India (CTRI).

Methods

We identified cancer trials registered in CTRI (between 2007 and 2021) using search terms adapted from the cancer types defined by the National Cancer Institute (USA). We then collated and analysed the publicly available information from CTRI (cancer subtypes, type of trial, treatment intent, type of intervention, sponsor type, recruitment countries) and used descriptive statistics to illustrate the overall as well as year-to-year trend.

Findings

In total, we identified 1988 cancer trials, the majority of which focused on treating cancer (63%) and rest of the trials aimed at optimising the operational aspects of surgery (19%), mitigating treatment-related toxicity (10.6%), or treating cancer-related symptoms (7.8%). Focusing on trials with the intent of treating cancer, we found that most were investigating solid tumours as opposed to haematological malignancies with the most prominent cancer subtypes being breast cancer (17%), head and neck cancer (9.8%), lung cancer (9.6%), and cervical cancer (6.6%). The number of trials conducted in a given cancer subtype from our analysis overall correlated to the incidence, mortality, and 5-year prevalence of the respective cancer subtype in India; however, head and neck cancer and cervical cancer were underrepresented in trials as compared with the disease burden. The most common type of intervention was investigational drugs. The most common sponsor types were global pharmaceutical industry (26%) and research institution and hospital (26%). Despite a relatively high cancer burden, the availability of cancer trials in the Northeastern states of India was limited.

Interpretation

There is a pressing need for clinical cancer research in India to be better aligned with the nation's healthcare needs and disease burden, focusing on prevalent and deadly cancers while ensuring the availability of clinical trials across geographic regions and underserved populations.