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Public health
Research
Sharing individual participant data from clinical studies: a cross-sectional online survey among Italian patient and citizen groups
  1. Cinzia Colombo1,
  2. Anna Roberto1,
  3. Karmela Krleza-Jeric2,3,4,
  4. Elena Parmelli5,
  5. Rita Banzi6
  1. 1 Department of Public Health, Laboratory for Medical Research and Consumer Involvement, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy
  2. 2 IMPACT Observatory, Visiting Scientist MedILS (Mediterranean Institute for Life Sciences), Split, Croatia
  3. 3 Cochrane Croatia, Split, Croatia
  4. 4 Electronic Health Information Laboratory, CHEO Research Institute, Ottawa, Ontario, Canada
  5. 5 Department of Epidemiology, Lazio Regional Health Service - ASL Roma 1, Rome, Italy
  6. 6 Center for Regulatory Policies, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy
  1. Correspondence to Dr Cinzia Colombo; cinzia.colombo{at}marionegri.it

Abstract

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.

  • individual participant data sharing
  • research transparency
  • patient and citizen groups

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-024863

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    Footnotes

    • Patient consent for publication Not required.

    • Contributors CC and RB: proposed the survey and drafted the questionnaire. KK-J, EP and AR: contributed to the final questionnaire. CC and AR: launched the survey, managed the reminders and the data collection. AR: analysed the data. CC, AR and RB: interpreted the data. CC and RB: drafted the manuscript. KKJ, EP and AR: substantially contributed to its content. All the authors approved the final manuscript.

    • Funding It was supported by internal funds of the Istituto di Ricerche Farmacologiche Mario Negri IRCCS in the context of the EU Horizon 2020 CORBEL project (grant agreement number 654248).

    • Competing interests None declared.

    • Ethics approval In view of the nature of this survey, no ethics committee approval was required, under Italian law. We asked patient and citizen groups' representatives to answer in the name of their groups. No personal names were collected, no cookies were used to assign a user identifier, and the IP address of respondents was not checked. We specified in the e-mail and in the introduction to the survey that the data were collected for research purposes, and that the Istituto di Ricerche Farmacologiche Mario Negri IRCCS was responsible for data collection and management. Participation in the survey was free and voluntary; participants actively chose to respond.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement The corresponding author will made available the dataset on request.