Presenting the results of clinical trials to participants

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         ■ PROFESSIONAL ISSUES                                                                 Clinical Medicine 2009, Vol 9, No 5: 415–16

         Presenting the results of clinical trials to participants

         Julie L Darbyshire, Rury R Holman and Hermione C Price

         Introduction                                                         trial allocated 708 participants with type 2 diabetes at random
                                                                              to the addition of a basal, biphasic or prandial insulin regimen
         Participants in clinical trials give their time and undergo pro-     to suboptimal oral antihyperglycaemic therapy (glycated
         cedures in the hope that they will obtain benefit for them-          haemoglobin (HbA1c) 7.0–10.0%). The one-year results,
         selves and that they will be contributing to the advancement         which were reported in September 2007,3 concluded that a
         of medical science.1 Traditionally little emphasis has been          single analogue-insulin formulation added to metformin and
         placed on informing participants of trial results, however, in       sulfonylurea resulted in an HbA1c of 6.5% or less in a minority
         the era of patient-centred care it is becoming increasingly          of participants. The addition of biphasic or prandial insulin
         recognised that researchers should involve participants to a         aspart reduced levels more than the addition of basal insulin
         greater extent in the design and operation of trials and take        detemir, but were associated with greater risks of hypogly-
         the time and effort to share the results appropriately. In addi-     caemia and weight gain.3
         tion, funding bodies and ethical committees now often ask for           On the day the results were presented and published,3 a
         information on how participants will be informed of results          press release was emailed to all clinical centres highlighting
         adding further need to address this important issue. It has          the main findings. Centres were requested to forward a
         even been suggested that opportunities for disseminating             printed copy of this press release to all their participants
         results form part of the informed consent process.2 The aim of       immediately. In addition the 4-T Steering Committee had
         this article is to highlight the need for researchers to commu-      agreed previously that there should be an informal opportu-
         nicate their results to study participants. Information was ret-     nity to share the results in detail with participants. While eth-
         rospectively collected from clinical centres who held a coffee       ical committees take a favourable view on those willing to take
         morning to disseminate the one-year results from the three-          the time to explain the results to their participants there is no
         year Treat to Target in Type 2 Diabetes (4-T) Trial (Current         consensus for a preferred format.2 All 4-T clinical centres were
         Controlled Trials number, ISRCTN 51125379).3 Following a             encouraged to organise an informal gathering or coffee
         discussion of the results, suggestions for how the information       morning. Centres were asked to report back to the 4-T coor-
         collected could be used to inform further work in this area are      dinating centre in Oxford with information about their coffee
         made.                                                                morning, including reasons for organising one, or not. One
                                                                              centre also provided anonymised comments from partici-
         Public understanding of science                                      pants. This information was then collated and reviewed.

         There is current academic and political interest in the com-
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