Larson Kristina, Sim Ida, von Isenburg Megan, Levenstein Marcia, Rockhold Frank, Neumann Stan, D'Arcy Catherine, Graham Elizabeth, Zuckerman David, Li Rebecca
Harvard, Center for Bioethics, Boston, MA, USA.
Vivli, Cambridge, USA; University of California, San Francisco, CA, USA.
Contemp Clin Trials. 2022 Apr;115:106709. doi: 10.1016/j.cct.2022.106709. Epub 2022 Feb 16.
This survey of COVID-19 interventional studies encompasses, and expands upon, a previous publication [1] examining individual participant level data (IPD) sharing intentions for COVID-related trials and publications prior to June 30, 2020.
Replicating our inclusion criteria from the original survey, we evaluated a larger dataset of 2759 trials and 281 publications in this follow-up survey for willingness to share IPD and studied if sharing sentiment has evolved since the beginning of the pandemic.
We found that 18 months into the pandemic, data sharing intentions remained static at 15% for trials registered through ClinicalTrials.gov (ClinicalTrials.gov is a digital registry of information about publicly and privately funded clinical studies in which human volunteers participate in interventional or observational scientific research) prior to September 19, 2021 compared to our initial survey. However, a comparison of declared intentions to share IPD at the time of publication revealed a noticeable shift: affirmative intentions grew from 21.4% (6/28) in our original publications survey to 57% (160/281) in this survey. Within the subset of studies published within journals affiliated with the International Committee of Medical Journal Editors (ICMJE), positive sharing intentions are even higher (65%).
Although intent to share data at the time of registration has not changed from our prior study in June 2020, there is growing commitment to sharing data reflected in the increasing number of affirmative declarations at the time of publication. Actual sharing of data will accelerate new insights into COVID-19 through secondary re-use of data.
本次对新冠病毒干预性研究的调查涵盖并扩展了之前的一篇出版物[1]，该出版物研究了2020年6月30日之前新冠相关试验和出版物的个体参与者水平数据（IPD）共享意愿。
我们沿用了原始调查的纳入标准，在本次后续调查中评估了一个更大的数据集，其中包括2759项试验和281篇出版物，以了解共享IPD的意愿，并研究自疫情开始以来共享意愿是否有所变化。
我们发现，在疫情爆发18个月后，与我们的初始调查相比，2021年9月19日之前通过ClinicalTrials.gov（ClinicalTrials.gov是一个关于公共和私人资助的临床研究信息的数字登记处，其中人类志愿者参与干预性或观察性科学研究）注册的试验的数据共享意愿保持在15%不变。然而，对发表时声明的共享IPD意愿进行比较后发现了一个明显的变化：肯定意愿从我们原始出版物调查中的21.4%（6/28）增长到本次调查中的57%（160/281）。在国际医学期刊编辑委员会（ICMJE）附属期刊发表的研究子集中，积极的共享意愿甚至更高（65%）。
尽管注册时的数据共享意愿与我们2020年6月的先前研究相比没有变化，但发表时肯定声明数量的增加反映出对数据共享的承诺在不断增强。通过对数据的二次再利用，实际的数据共享将加速对新冠病毒的新见解。
