Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York, NY.
Molecular Biotechnologies and Health Sciences, Torino University, Torino, Italy.
Clin Lymphoma Myeloma Leuk. 2020 Feb;20(2):e82-e86. doi: 10.1016/j.clml.2019.11.011. Epub 2019 Nov 21.
ClinicalTrials.gov is used by clinicians and patients to identify clinical trials. We assessed the ease with which users could identify relevant trials related to lymphoma using the short and official titles. We hypothesized that lymphoma titles frequently lack important information.
We performed 2 searches on ClinicalTrials.gov. The first search was performed before June 2017, when ClinicalTrials.gov underwent updates to improve usability. The second was performed after 2017. We assessed whether the short and official titles of each trial provided information on the study phase, eligible disease status, lymphoma histologic subtype, study intervention, primary objective, and the presence of randomization and placebo control.
Of the pre-overhaul lymphoma trials, the official versus short titles included information regarding study intervention (99% vs. 96%), study phase (82% vs. 14%), lymphoma histologic subtype (78% vs. 72%), disease status (46% vs. 35%), randomization (13% vs. 2%), presence of placebo (6% vs. 2%), and primary objective (38% vs. 26%). Of the post-overhaul trials, the official versus short titles included information regarding study intervention (97% vs. 96%), lymphoma histologic subtype (83% vs. 78%), study phase (78% vs. 8%), disease status (64% vs. 50%), primary objective (38% vs. 23%), presence of placebo (11% vs. 0%), and randomization (18% vs. 0%).
The official titles were more informative than were the short titles on ClinicalTrials.gov. However, the short and official titles both often lacked the basic information needed to understand a clinical trial. This has persisted despite updates to the platform. These results highlight the need for standardization of the format and content included in study titles.
ClinicalTrials.gov 被临床医生和患者用于识别临床试验。我们评估了用户使用简短和官方标题识别与淋巴瘤相关的相关试验的容易程度。我们假设淋巴瘤标题经常缺乏重要信息。
我们在 ClinicalTrials.gov 上进行了 2 次搜索。第一次搜索是在 2017 年 6 月之前进行的,当时 ClinicalTrials.gov 进行了更新以提高可用性。第二次是在 2017 年之后进行的。我们评估了每个试验的简短和官方标题是否提供了关于研究阶段、合格疾病状态、淋巴瘤组织学亚型、研究干预、主要目标以及随机化和安慰剂对照的信息。
在预更新的淋巴瘤试验中,官方标题与简短标题相比,包含了有关研究干预(99%对 96%)、研究阶段(82%对 14%)、淋巴瘤组织学亚型(78%对 72%)、疾病状态(46%对 35%)、随机化(13%对 2%)、安慰剂存在(6%对 2%)和主要目标(38%对 26%)的信息。在更新后的试验中,官方标题与简短标题相比,包含了有关研究干预(97%对 96%)、淋巴瘤组织学亚型(83%对 78%)、研究阶段(78%对 8%)、疾病状态(64%对 50%)、主要目标(38%对 23%)、安慰剂存在(11%对 0%)和随机化(18%对 0%)的信息。
官方标题比 ClinicalTrials.gov 上的简短标题提供了更多信息。然而,简短和官方标题都经常缺乏理解临床试验所需的基本信息。尽管对平台进行了更新,但这种情况仍在持续。这些结果强调了需要标准化研究标题的格式和内容。