Sharing individual participant data from clinical studies: a cross-sectional online survey among Italian patient and citizen groups
Sharing individual participant data from clinical studies: a cross-sectional online survey among Italian patient and citizen groups
复制标题
DOI：
10.1136/bmjopen-2018-024863
复制
发表时间：
2019-06-01
期刊：
影响因子：
2.9
通讯作者：
Banzi, Rita
中科院分区：
文献类型：
--
作者：
Colombo, Cinzia;Roberto, Anna;Banzi, Rita
目的了解意大利患者和公民群体对临床研究中个体参与者数据(IPD)共享的争论、意见和态度。设计横断面在线调查。设置和参与者通过电子邮件向2003年意大利患者和公民群体的联系人发送一份包含22个项目的在线问卷。我们收到了311份回复，检查了重复受访者(16人)；295个单一群体回复，280份问卷符合分析条件(回复率15%)。90人(32.1%)涉及肿瘤学和姑息治疗，175人(46.2%)在当地或地区手术，136人(48.6%)参与临床研究。调查数据包括意大利患者和公民群体对IPD共享的自我报告的知识、态度和意见、IPD获取机制、优势和风险。结果半数受访者(144人，51%)对IPD共享辩论有一定了解，60人(42%)表示他们有官方立场(35人赞成，19人赞成限制，2人反对，1人既不支持也不反对，3人失踪)。19人讨论了这项调查所鼓励的主题；39%的人赞成研究人员和其他专业人员广泛获取信息，并将信息提供给参与者、数据识别、安全档案、获取协议和对滥用的制裁作为IPD共享模式的重要方面。答复者强调，参与者不同意的目的的重新识别、隐私和重复使用数据是主要风险，推进创新和减少研究浪费是主要优势。大约一半的人认为IPD分享不会阻碍学生参与学习。结论一半的受访者知道这场辩论。那些有官方立场的人主要赞成分享知识产权。许多人支持广泛的准入，要求对处理知识产权共享的实体建立信任的重要条件。这些调查结果虽然受到答复率低的限制，但加强了对问责明确的可靠和透明程序的需求。
Objectives To gather knowledge on the current debate, opinions and attitudes of Italian patient and citizen groups on individual participant data (IPD) sharing from clinical studies.Design Cross-sectional online survey.Setting and participants A 22-item online questionnaire was sent by email to 2003 contacts of patient and citizen groups in Italy. We received 311 responses, checked for duplicate respondents (16); 295 single groups responded, 280 providing questionnaires eligible for analysis (response rate 15%). Ninety (32.1%) dealt with oncology and palliative care, 175 (46.2%) operated locally or regionally and 136 (48.6%) were involved in clinical research.Outcome measure Data on Italian patient and citizen groups' self-reported knowledge, attitudes and opinions on IPD sharing, mechanisms for IPD access, advantages and risks.Results Half the respondents (144 out of 280, 51%) had some knowledge about the IPD sharing debate, and 60 (42%) stated they had an official position (35 in favour, 19 in favour with restrictions, 2 against, 1 neither for nor against, 3 missing). Nineteen discussed the topic encouraged by this survey; 39% approved broad access by researchers and other professions and identified information to participants, data de-identification, secure archives, access agreements and sanctions for misuse as important aspects of IPD sharing models. Respondents highlighted re-identification, privacy and re-use of data for purposes that participants do not agree on, as main risks, advancement of innovation and reducing waste in research as main advantages. Around half believed IPD sharing would not discourage study participation.Conclusions Half the respondents were aware of the debate. Those who had an official position were mainly in favour of IPD sharing. Many supported broad access, asking for conditions important for building trust in entities that handle IPD sharing. Although limited by the low response rate, these findings reinforce the demand for reliable and transparent processes where accountabilities are clear.