Why did it take 19 months to retrieve clinical trial data from a non-profit organisation?

Missing data in clinical trials is a major problem. One would expect the situation to be better for trials funded by large non-profit organisations that are free of commercial bias, and with policies for transparency and data sharing. However, in our experience with a non-profit trial funder we found this was not the case. Indeed, it was so bureaucratic that, despite the good intentions of the authors and others involved, accessing the data proved to be very difficult.

We wanted to study how treatment effects in randomised clinical trials were affected by a failure to blind the outcome assessors. We therefore systematically reviewed trials where the same outcome had been assessed by both a blind and a non-blind assessor within the same trial.1 2 One eligible study was a large, well performed trial of the effect of electrical deep brain stimulation for patients with advanced Parkinson disease, published in JAMA in January 2009.3 The trial was partially funded by the Cooperative Studies Program of the Department of Veterans Affairs’ Office of Research and Development. JAMA reported UPDRS motor scores (Unified Parkinson’s Disease Rating Scale III) evaluated by blind assessors, but did not report the scores evaluated by the non-blind assessors.

On 12 June 2009 we emailed the corresponding author to ask if the researchers would share the results of the unpublished non-blind UPDRS scores. We asked for summary statistics: means, standard deviations, and number of patients for the experimental group and for the control group—a total of six numbers.

After a month we received a friendly reply stating that the data could not yet be released, and four days later a follow-up email asking us to fill in a data use agreement form that would be sent for approval to the Department of Veterans Affairs’ Office of Research and Development.

The data use agreement form required us to promise to send our manuscript, when finished, for approval at the Department of Veterans Affairs. We thought this problematic, modified the section, and submitted the agreement form. However, on 28 July 2009 we received an email asking us to reverse our modification, assuring us “. . . that this approval is not meant to delay submission and will not be unreasonably withheld.” Hesitantly, we went along with this. The next day we received an email asking us for further details about the required data, and we filled in a third data use agreement form.

During the next six months we sent five emails asking for information on progress and were told that our request was under review at the central office.

On 4 February 2010 we received a further email: “Your request for data . . . has undergone further review. At this time we ask that you please modify the Data Use Agreement as follows: Item #10: For the approved retention date, please replace ‘within 1 month of publication of the meta-analysis manuscript’ with an actual calendar date.”

We filled in a fourth data use agreement form.

During the next five months we sent four emails asking for information on progress and were told each time that our request was under review at the central office.

On 30 August 2010, 14 months after our initial contact, we received the news that the central office had approved our request and that a statistician would supervise the data transfer. On 21 September 2010 the statistician wrote to us that, “I noticed on page 2 of DUA [data use agreement form] item #12—‘The Nordic Cochrane Center will obtain the necessary documentation from the responsible IRB [institutional review board] that the research activities using this data are approved or ‘waived’. . . . Would you please forward any written evidence of your IRB’s decision?”

Meta-analyses generally do not require ethical approval as they are based on previously assembled data, and in this case, we requested summary statistics, and not individual patient data. Still, we complied and obtained and passed on a formal waiver from our local institutional review board. On 18 October 2010 we received a new email from the statistician requesting further clarification about which data to transfer, to which we responded a week later.

On 19 November 2010 we asked for information on progress and the statistician replied the same day: “All computers . . . are blocked for burning CD except that [sic] a waiver is approved by high level administrators. The approving process is still ongoing now. I will ask whether I can release your request via email since it’s just the summary results similar to the papers.”

In December 2010 and in early January 2011 we sent emails asking for information on progress. On 12 January 2011 the data were transferred to us—five months after the transfer had been authorised.

We included the trial in our meta-analysis1 and sent our unpublished manuscript for formal approval in December 2012, which was granted only two days later.

The emails we received during the prolonged exchange were all friendly, and the individuals involved were helpful and understood the need for data sharing, but they were hampered by inflexible, formalistic, and slow bureaucratic procedures. Since our first inquiry we communicated with four people, sent 25 emails, filled in four data use agreement forms, and waited one year and seven months.

Governmental and other non-profit organisations that fund randomised trials need to address the problem of unpublished data, and to introduce policies that further advance medical science through appropriate responses to reasonable requests for unpublished data needed in meta-analyses.