Pharmacy Department, Jianhu People's Hospital, Jianhu, Jiangsu Province, 224700, People's Republic of China.
Department of Oncology, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, 325000, People's Republic of China.
Int J Nanomedicine. 2022 Apr 26;17:1843-1850. doi: 10.2147/IJN.S359666. eCollection 2022.
Clinical trials have become essential for driving the development of medicine. However, little is known about the current status of clinical trials on liposomes in children's anticancer therapy (LCAT). This study aimed to synthesize current finding from clinical trials of LCAT in ClinicalTrials.gov.
A cross-sectional descriptive study of clinical trials on LCAT was conducted, using studies registered on ClinicalTrials.gov through December 30, 2021.
A total of 74 eligible trials were identified, accounting for 4.8% (74/1552) of all trials on liposomes for cancer therapy. Among these trials, 70 (94.6%) were interventional trials, and the remaining 4 (5.4%) were observational trials. Of the 70 interventional trials, 63 (90.0%) were for treatment, 48.6% were involving unlabeled allocations, 30.0% were randomized, 52.9% were single group assignment, 71.4% were without masking, 28.6% were Phase 3 trials, 30.0% were Phase 1 trials, and 24.3% were Phase 2 trials. Furthermore, 17 liposomal drugs for 123 types of cancer were investigated in the interventional trials, and these were mainly focused on organic chemicals (43/70, 61.4%). Of these cancers, the highest proportion was leukemia (15.4%), followed by lymphoma (9.8%) and ovarian cancer (8.9%).
High quality, adequately powered, masked, appropriately sized, and randomized clinical trials represent the critical priorities for conducting a high-quality clinical trial. However, most of these trials for LCAT were non-randomized, single group assignment, and non-blinded interventional trials of small scale, with various eligibility criteria and outcome measures. Our analysis highlights the need for improvement in the completeness of study designs curated on clinicalTrials.gov. We urge for decision-makers to avoid adopting entrenched positions about the study design of cancer clinical trials to avoid this problem. As such, tackling the problematic challenges related to cancer and designing efficient trials for cancer requires developing and applying new approaches and multiple strategies.
临床试验已成为推动医学发展的关键。然而，对于儿童抗癌治疗中的脂质体临床试验（LCAT）的现状知之甚少。本研究旨在通过 ClinicalTrials.gov 综合 LCAT 临床试验的现有研究结果。
通过对 2021 年 12 月 30 日前在 ClinicalTrials.gov 上注册的 LCAT 临床试验进行横断面描述性研究。
共纳入 74 项符合条件的试验，占脂质体治疗癌症所有试验的 4.8%（74/1552）。其中 70 项为干预性试验，其余 4 项为观察性试验。70 项干预性试验中，63 项为治疗性试验，未标记分配占 48.6%，随机分组占 30.0%，单组分配占 52.9%，无盲法占 71.4%，3 期试验占 28.6%，1 期试验占 30.0%，2 期试验占 24.3%。此外，17 种脂质体药物用于治疗 123 种癌症，主要集中在有机化学品（43/70，61.4%）。在这些癌症中，白血病比例最高（15.4%），其次是淋巴瘤（9.8%）和卵巢癌（8.9%）。
高质量、充分效能、盲法、适当规模和随机临床试验是开展高质量临床试验的关键优先事项。然而，LCAT 的大多数临床试验是非随机的、单组分配的和非盲的小规模干预性试验，具有各种纳入标准和结局指标。我们的分析强调了需要提高 ClinicalTrials.gov 上研究设计的完整性。我们敦促决策者避免对癌症临床试验的研究设计采取固有的立场，以避免这个问题。因此，解决与癌症相关的问题并为癌症设计高效的试验需要开发和应用新的方法和多种策略。
