during meeting
Other catering costs (customary to include at least a group evening meal)
Travel costs or bursaries (taking account of geographical location of studies when costing)
Accommodation (those travelling long distance may require this pre‐ or post‐meeting)
Dissemination Costs
Costs associated with presenting results at relevant conference
Open access publishing fees
Production of plain language summaries
Production of any web or other audio/visual materials
The above listing covers typical costs, and should be adapted according to the specific requirements of the project.
Source: Lesley Stewart.
A commonly asked question is whether trial investigators should be paid to participate and prepare their IPD. Whilst this acknowledges contribution and may reimburse or partially reimburse time taken to prepare data, there is no evidence that offering funds provides an incentive to collaborate, particularly if it is a token amount (as shown in a randomised trial75). Many IPD meta‐analysis projects have been completed successfully without offering payment, and routinely paying for data provision could render many IPD projects unaffordable. Ideally, the ability to provide robust answers to questions that are likely to matter to trial investigators and the academic credit generated through involvement in an IPD meta‐analysis (including authorship), will provide sufficient motivation to participate. Moreover, for more recent trials that have been managed and stored following good practice, it should be relatively straightforward for trial personnel to export and potentially even to re‐code their IPD. Indeed, many trials are funded by organisations that expect trial data to be made available for other researchers on trial completion (Box 3.4). One option may be to provide some assistance in the form of data preparation bursaries for those who would otherwise have difficulty in securing the staff time needed to prepare the data. For example, bursaries might be warranted if trial personnel have moved institutions but are willing to prepare IPD in their own time; or if IPD are archived and costs are associated with retrieving this or in transposing data from obsolete storage media. However, this is difficult to predict and remains a difficult issue that will require careful assessment in relation to specific IPD meta‐analysis circumstances.
If IPD are to be obtained from repositories, any costs associated with this need to be incorporated in the budget, including any hidden costs such as a requirement for specialist software or licences to read original data. For example, an IPD network meta‐analysis that wished to use data from pharmaceutical company trials through clinicalstudydatarequest.com was required to have a WHO Drug Dictionary license at an approximate cost of almost £7,000 per sponsor.75
Costs for any planned patient and public involvement and engagement (PPIE) should be included. These should capture reimbursement of travel and incidental expenses associated with attending meetings and include payment for time preparing for and attending these meetings. Payment for time may be made at a generally accepted rate, for example those recommended by INVOLVE in the UK (available at www.invo.org.uk/resource-centre/payment-and-recognition-for-public-involvement/).80 Because payment to individuals may have implications for their tax or welfare payments, a donation to a patient group or charity may be preferred. For costing purposes it is reasonable to assume that these would be the same amount as would be paid to individuals. Costs associated with advisory group meetings should also be accounted for, for all group members.
One aspect of a collaborative IPD meta‐analysis that can incur additional cost is hosting an in‐person meeting of trial investigators and advisory group members, at which results are first presented and discussed. As well as providing some incentive to participate, this can aid interpretation and help cascade and disseminate results (Chapter 10). Past experience suggests that holding these as physical meetings works well, although they can be costly. Hosting results meetings alongside a major conference that trial investigators are likely to attend can reduce costs, although it may be more difficult to find a venue and keep participants present and engaged. Costing such a meeting will need to include venue and catering costs, and any accommodation and travel that will be supported through the project. Providing accommodation and subsistence for the duration of the IPD meeting is commonly done. Sometimes travel bursaries are offered, for example, to cover costs for those who would not be attending a main conference to which the IPD project meeting may be aligned. For a well‐funded project, travel (economy) may be supported for all those attending. Travel should always be reimbursed for PPIE members.
An alternative is to hold a virtual meeting. Although there is not yet a great deal of experience of how successful on‐line meetings are for presenting and discussing IPD meta‐analysis results, with ever‐improving virtual meeting software and with more individuals mindful of environmental sustainability and their carbon footprint, they may ultimately be the best option and help contain the costs of IPD meta‐analysis projects. Furthermore, following the 2020 SARS‐CoV2 pandemic and widespread use of online meeting software to host meetings and conferences, virtual meetings have become more commonplace.
Box 3.4 Examples of research funder support for sharing clinical trial data
Cancer Research UK
https://www.cancerresearchuk.org/sites/default/files/cruk_data_sharing_policy_2017_final.pdf
Cancer Research UK regards it good research practice for all researchers to consider at the research proposal stage how they will manage and share the data they will generate. Therefore, Cancer Research UK requires that applicants applying for funding provide a data management and sharing plan as part of their application. This plan will be reviewed as part of the funding decision.
European Research Council
Grantees to provide information on how their data sets can be accessed, including the terms‐of‐use or the licence under which they can be accessed and re‐used, and information on any restrictions that may apply. It is also important to specify and justify the timing of data sharing. This could be, for example, as soon as possible after the data collection, or at the end of the project. For data that underlie publications it could be, for example, at the time of publication or pre‐publication.
National Institutes of Health
https://grants.nih.gov/grants/policy/data_sharing/
In NIH’s view, all data should be considered for data sharing. Data should be made as widely and freely available
