Procedures

Protocol for analyses
The OA Trial Bank stimulates new initiatives and research questions from researchers and clinicians worldwide. New initiatives will all need to be approved by the steering committee of the OA Trial Bank by means of a study protocol. This study protocol will at least include the following items: study selection (type of studies, participants, type of interventions) baseline assessments, outcomes measures, the subgroups of interest and the actual statistical subgroup analyses. All analyses done under the umbrella of the OA Trial Bank are predefined.
 
New initiated projects can make use of the structure of the OA Trial Bank in terms of support in study protocols, providing a license agreement for data-exchange, support in data analyses and provide storage of data. 
 
Approval Steering Committee
A chairman, steering committee and an executive coordinator formalize the OA Trial Bank. The steering committee guarantees continuity of the OA Trial Bank, supervises the executive coordinator and approves and agrees on all decisions made and methods applied, i.e. agree on organisational structure and tasks of all parties involved; agree on the design and methods of meta-analyses, definition of subgroups, statistical analyses; provides the content of the license agreement (data access, transfer and storage, predefined analyses, confidentiality and reliability statement, authorship) between data-deliverers and the OA Trial Bank; ensures handling of data and provides a safe data storage. 
 
The steering committee currently consists of five internationally acknowledged clinical and epidemiological researchers in the OA field, a delegate of the main funder (Dutch Arthritis Foundation), a delegate of the OsteoArthritis Research Society International (OARSI), a delegate of the European League Against Rheumatism (EULAR) and two representatives of patient and public involvement (PPI) (members of the Arthritis Research UK OA Research Users Group). The executive coordinator is responsible for the daily management of the OA Trial Bank, and performs or supervises the data-analyses.
 
Data collection, transfer and storage
After a systematic search of the literature, all corresponding authors of eligible trials of new initiatives of the OA Trial Bank will be approached and asked to cooperate in this project. When the corresponding authors cannot be reached, the institutes in which the trials have been performed will be contacted. All data-delivers (i.e. the research institutes who own the data) that are willing to participate will be asked to sign the data delivery license agreement, including items on input data, obligations, ownership of data, terms, authorship, the statistical analyses and publications. The executive coordinator of the OA Trial Bank will visit the institutes of the data-deliverers once or will transfer the data by digital secured transfer. Data sets will be accepted in any kind of electronic format (for example SPSS, Stata, SAS, Excel) or in paper form, provided that variables and categories are adequately labelled within the data set or with a separate code-book. The original data collection files collected by the coordinator will be kept in their original version and will be saved on a secured server at the Erasmus MC Medical University in Rotterdam, the Netherlands. To ensure the quality of the data, they will be independently checked for data entry mistakes and consistency and the sum of the individual patient results received will be compared with the published summary results from the primary studies. In case of differences, authors will be contacted and discrepancies should be resolved after discussion. 
 
To ensure accurate pooling of data, all items will be consistently derived from the original databases by the coordinator of the OA Trial Bank. All anonymous data will be transferred to a secured database at the Erasmus MC Medical University in Rotterdam. The data set will not be used for any other research apart from that described in the license agreement
 
Role of data-deliverers
 -Data Deliverer provides pseudonymised or anonymised digital data resulting from one or more clinical trials to the OA Trial Bank
- The Data Deliverer grants the Erasmus MC a royalty-free, non-exclusive licence in respect of the data to import and include the data in the OA Trial Bank and allows to use and process the data for the predefined analyses. 
- The Data Deliverer can play an active role:
a.) where a Data Deliverer or one of its employees is willing to perform the data analyses and is permitted to do so by the OA Trial Bank steering committee, the Data Deliverer and the executive coordinator will agree upon a timeframe for the analyses of the Data, writing a draft publication and submitting this publication to a renowned medical journal
b.) All data-deliverers will have the possibility to become a (co-)author on the publications derived from the analyses. All follow the criteria established by the International Committee of Medical Journal Editors.