- Email: [email protected]
Billion dollar baby
Thrombosis Research 149 (2017) 81
Contents lists available at ScienceDirect
Thrombosis Research journal homepage: www.elsevier.com/locate/thromres
Editorial
Billion dollar baby
It is incredible that clinical trial research has become so heavily bureaucratised that some clinical trials now cost over a billion dollars to conduct. Luckily there are initiatives like MoreTrials (moretrials. net) that seek to modernise ICH-GCP (International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use- Good Clinical Practice) so that sensible and risk adapted regulatory approaches may be developed and followed. For example, insisting on retrieval and central storage of medical licences and updated CVs yearly for all participating investigators in studies does not save lives, but it does kills trees. Surely, if an investigator in an academic institution is participating in a trial we can assume that the academic institution will continually ensure that they are qualified to practice medicine in their institution. Instead, the regulators insist that valuable clinical trial funding is spent on a continuous paper chase. Sure, we understand the need for a qualification process in private practices that conduct research but the reality is that most clinical research is conducted in academic centers. ICH- GCP insists on universal processes rather than risk adapted processes. In another example, one can imagine that trials of very benign interventions might be regulated differently than trials of high risk interventions but that is not the case- one regulatory size fits all clinical research. There is ample evidence- published and anecdotal- that clinical investigators are fed up and leaving clinical research. What a tragedy! Unfortunately it is reality and the retreat of investigators is impacting the pace of clinical discovery and innovation in health care at tremendous financial and human cost. In this month’s journal, Venetsanos et al describe a trial of a very simple intervention of chewing rather than swallowing ticagrelor and showed more rapid platelet inhibition with chewing ticagrelor [1]. No doubt a lot of paper work went into developing, implementing and conducting this simple trial. Robert-Ebadi report on the management of distal deep vein thrombosis [2] and highlight the results of Marc Righini’s Cactus trial- another important trial that despite the weight of regulatory burden was conducted through the persistence of the
http://dx.doi.org/10.1016/j.thromres.2016.12.012 0049-3848/© 2016 Published by Elsevier Ltd.
investigators and showed that more anticoagulation is not necessarily better care for distal DVT. Speaking of billion dollar trials, BeyerWestendorf describes a secondary analysis of the large Einstein and Amplify trials exploring the effects of patient selection on results, highlighting for us that cross trial comparisons can be risky business [3]. Thank you to all clinical investigators for your persistence. Happy New Year to all! Let’s hope that 2017 brings more sensible clinical trial regulation. References [1] D. Venetsanos, S.S. Lawesson, E. Swahn, J. Alfredsson, Chewed ticagrelor tablets provide faster platelet inhibition compared to integral tablets: The inhibition of platelet aggregation after administration of three different ticagrelor formulations (IPAADTica) study, a randomised controlled trial, 2017http://dx.doi.org/10.1016/j. thromres.2016.10.013. [2] H. Robert-Ebadi, M. Righini, Management of distal deep vein thrombosis, Thromb. Res. 149 (2017) 48–55. [3] J. Beyer-Westendorf, A.W.A. Lensing, R. Arya, H. Bounameaux, A.T. Cohen, P.S. Wells, et al., Choosing wisely: The impact of patient selection on efficacy and safety outcomes in the EINSTEIN-DVT/PE and AMPLIFY trials, Thromb. Res. 149 (2017) 29–37.
Marc Rodger Ottawa Hospital, Box 201, 451 Smyth rd, Ottawa, Canada E-mail address: [email protected]. Twitter: @RodgerMarc
Henri H. Versteeg Leiden University Medical Center, Albinusdreef 2, Leiden, Netherlands Corresponding author. E-mail address: [email protected]. Twitter: @HenriVersteeg
Contents lists available at ScienceDirect
Thrombosis Research journal homepage: www.elsevier.com/locate/thromres
Editorial
Billion dollar baby
It is incredible that clinical trial research has become so heavily bureaucratised that some clinical trials now cost over a billion dollars to conduct. Luckily there are initiatives like MoreTrials (moretrials. net) that seek to modernise ICH-GCP (International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use- Good Clinical Practice) so that sensible and risk adapted regulatory approaches may be developed and followed. For example, insisting on retrieval and central storage of medical licences and updated CVs yearly for all participating investigators in studies does not save lives, but it does kills trees. Surely, if an investigator in an academic institution is participating in a trial we can assume that the academic institution will continually ensure that they are qualified to practice medicine in their institution. Instead, the regulators insist that valuable clinical trial funding is spent on a continuous paper chase. Sure, we understand the need for a qualification process in private practices that conduct research but the reality is that most clinical research is conducted in academic centers. ICH- GCP insists on universal processes rather than risk adapted processes. In another example, one can imagine that trials of very benign interventions might be regulated differently than trials of high risk interventions but that is not the case- one regulatory size fits all clinical research. There is ample evidence- published and anecdotal- that clinical investigators are fed up and leaving clinical research. What a tragedy! Unfortunately it is reality and the retreat of investigators is impacting the pace of clinical discovery and innovation in health care at tremendous financial and human cost. In this month’s journal, Venetsanos et al describe a trial of a very simple intervention of chewing rather than swallowing ticagrelor and showed more rapid platelet inhibition with chewing ticagrelor [1]. No doubt a lot of paper work went into developing, implementing and conducting this simple trial. Robert-Ebadi report on the management of distal deep vein thrombosis [2] and highlight the results of Marc Righini’s Cactus trial- another important trial that despite the weight of regulatory burden was conducted through the persistence of the
http://dx.doi.org/10.1016/j.thromres.2016.12.012 0049-3848/© 2016 Published by Elsevier Ltd.
investigators and showed that more anticoagulation is not necessarily better care for distal DVT. Speaking of billion dollar trials, BeyerWestendorf describes a secondary analysis of the large Einstein and Amplify trials exploring the effects of patient selection on results, highlighting for us that cross trial comparisons can be risky business [3]. Thank you to all clinical investigators for your persistence. Happy New Year to all! Let’s hope that 2017 brings more sensible clinical trial regulation. References [1] D. Venetsanos, S.S. Lawesson, E. Swahn, J. Alfredsson, Chewed ticagrelor tablets provide faster platelet inhibition compared to integral tablets: The inhibition of platelet aggregation after administration of three different ticagrelor formulations (IPAADTica) study, a randomised controlled trial, 2017http://dx.doi.org/10.1016/j. thromres.2016.10.013. [2] H. Robert-Ebadi, M. Righini, Management of distal deep vein thrombosis, Thromb. Res. 149 (2017) 48–55. [3] J. Beyer-Westendorf, A.W.A. Lensing, R. Arya, H. Bounameaux, A.T. Cohen, P.S. Wells, et al., Choosing wisely: The impact of patient selection on efficacy and safety outcomes in the EINSTEIN-DVT/PE and AMPLIFY trials, Thromb. Res. 149 (2017) 29–37.
Marc Rodger Ottawa Hospital, Box 201, 451 Smyth rd, Ottawa, Canada E-mail address: [email protected]. Twitter: @RodgerMarc
Henri H. Versteeg Leiden University Medical Center, Albinusdreef 2, Leiden, Netherlands Corresponding author. E-mail address: [email protected]. Twitter: @HenriVersteeg