Payedimarri Anil Babu, Mouhssine Samir, Aljadeeah Saleh, Gaidano Gianluca, Ravinetto Raffaella
Division of Public Health, Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy.
Division of Hematology, Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy.
BMJ Oncol. 2023 Sep 30;2(1):e000101. doi: 10.1136/bmjonc-2023-000101. eCollection 2023.
Breast, lung, colon cancers are the 'big killers' in oncology. Access to innovative treatments lags behind in low-income and middle-income countries. We investigated the geographic distribution of industry-sponsored trials; and whether results were reported in clinical trial registries.
We conducted a search in ClinicalTrials.gov by: (i) study type: interventional; (ii) condition: breast, lung, colon cancer; (iii) phases: I-IV; (iv) funder: industry. Trials registered as of 30 June 2018 were extracted; for completed trials, a second extraction was performed on 30 September 2022.
We included 4177 trials. Phase I-IV trials involving only high-income countries were 3254/4177 (77.9%), while 923/4177 (22.1%) trials included at least one site in middle-income countries (MICs). Most phase III trials (416/688; 60.5%) involved MICs, including only lower MICs (6/416, 1.4%), only upper MICs (225/416, 54.1%) and lower and upper MICs (185/416, 44.5%). Phase IV trials involved MICs in 45/89 (50.6%) cases. Phase I and II trials included MICs in smaller proportions (72/950, 7.6% and 390/2450, 15.9%, respectively). No trials were run in low-income countries (LICs). Among completed trials, 430 out of 1854 (23.2%) involved MICs. Results had not been entered in the registry in 63.4% (1176/1854) of trials overall and 49.5% (213/430) of trials involving MICs.
Trials for breast, lung and colon cancers are increasingly delocalised to countries likely unable to get access to innovative medicines. Furthermore, LICs are not hosting any industry-sponsored trials. Measures are needed to ensure benefit-sharing for trials countries; to improve transparency and to stimulate research addressing the needs of LICs.
乳腺癌、肺癌和结肠癌是肿瘤学领域的“重大杀手”。在低收入和中等收入国家，获得创新治疗的机会滞后。我们调查了行业资助试验的地理分布情况，以及试验结果是否在临床试验注册库中报告。
我们在ClinicalTrials.gov上进行了检索，检索条件为：（i）研究类型：干预性；（ii）疾病：乳腺癌、肺癌、结肠癌；（iii）阶段：I - IV期；（iv）资助者：行业。提取截至2018年6月30日注册的试验；对于已完成的试验，于2022年9月30日进行了二次提取。
我们纳入了4177项试验。仅涉及高收入国家的I - IV期试验有3254/4177项（77.9%），而923/4177项（22.1%）试验至少在一个中等收入国家设有研究点。大多数III期试验（416/688项；60.5%）涉及中等收入国家，包括仅涉及低收入中等收入国家的试验（6/416项，1.4%）、仅涉及高收入中等收入国家的试验（225/416项，54.1%）以及同时涉及低收入和高收入中等收入国家的试验（185/416项，44.5%）。IV期试验中有45/89项（50.6%）涉及中等收入国家。I期和II期试验涉及中等收入国家的比例较小（分别为72/950项，7.6%和390/2450项，15.9%）。低收入国家没有开展任何试验。在已完成的试验中，1854项中有430项（23.2%）涉及中等收入国家。总体而言，63.4%（1176/1854）的试验结果未录入注册库，涉及中等收入国家的试验中有49.5%（213/430）的试验结果未录入。
乳腺癌、肺癌和结肠癌的试验越来越多地转移到可能无法获得创新药物的国家。此外，低收入国家没有开展任何行业资助的试验。需要采取措施确保试验国家能够分享利益，提高透明度，并促进针对低收入国家需求的研究。
