title: Sharing data from clinical trials: the rationale for a controlled access approach.
abstract: BACKGROUND
  The move towards increased transparency around clinical trials is welcome. Much focus has been on under-reporting of trials and access to individual patient data to allow independent verification of findings. There are many other good reasons for data sharing from clinical trials. We describe some key issues in data sharing, including the challenges of open access to data. These include issues in consent and disclosure; risks in identification, including self-identification; risks in distorting data to prevent self-identification; and risks in analysis. These risks have led us to develop a controlled access policy, which safeguards the rights of patients entered in our trials, guards the intellectual property rights of the original researchers who designed the trial and collected the data, provides a barrier against unnecessary duplication, and ensures that researchers have the necessary resources and skills to analyse the data.
  
  
  METHODS
  We briefly discuss the practicalities of our current approach to data sharing, including ensuring that data are discoverable and how to deal with old studies. We describe data sharing activities at the MRC Clinical Trials Unit.
  
  
  RESULTS
  One hundred and three data sharing activities were logged from 2012 to 2014 from external and internal applicants. The motivations are varied, but none have been for replication of the primary results.
  
  
  CONCLUSIONS
  For any request to share data, we note the important role of independent reviewers as well as reviewers who know the study well, and present some of the key questions that all reviewers should ask when deciding whether a request is reasonable. We consider the responsibilities of all parties. We highlight the potential for opportunity costs. Clinical trial data should be shared for reasonable requests but there are many practical issues that must be explicitly considered.
authors: Medical Research Council Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London, WC2B 6NH, UK. m.sydes@ucl.ac.uk.
authors: Matthew R
authors: MR
authors: Sydes
authors: Medical Research Council Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London, WC2B 6NH, UK. tony.johnson@ucl.ac.uk.
authors: Anthony L
authors: AL
authors: Johnson
authors: Medical Research Council Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London, WC2B 6NH, UK. s.meredith@ucl.ac.uk.
authors: Sarah K
authors: SK
authors: Meredith
authors: Medical Research Council Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London, WC2B 6NH, UK. m.rauchenberger@ucl.ac.uk.
authors: Mary
authors: M
authors: Rauchenberger
authors: Medical Research Council Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London, WC2B 6NH, UK. a.south@ucl.ac.uk.
authors: Annabelle
authors: A
authors: South
authors: Medical Research Council Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London, WC2B 6NH, UK. m.parmar@ucl.ac.uk.
authors: Mahesh K B
authors: MK
authors: Parmar
mesh_terms: D022126:Access to Information; D002986:Clinical Trials as Topic / Q000379:methods*; D003299:Cooperative Behavior; D000068240:Data Anonymization; D016208:Databases, Factual; D030881:Disclosure; D006801:Humans; D033181:Information Dissemination; D007258:Informed Consent; D011050:Policy Making; D012107:Research Design