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International Clinical Trials

Biomarkers – How to Manage a Revolution

In putting the needs of the patient first, Lawrence K Oliver of Mayo Clinical Trial Services at Mayo Clinic believes that responsibility for decision-making must be clearly assigned

Revolutions are intended to be disturbing. By the time the revolution is in full swing change has become mandatory and the ‘old ways’ have been discarded. Until the new order is established there is anxiety, since no one knows what the outcome will be. The zealots fomenting the revolution have a clear picture of their desired future (anarchists excluded), but the others affected seem doomed to wait and watch. It’s surprising that the coining of the term biomarkers signalled the beginning of the recognition that this is a revolution.

Laboratory indications of biochemical changes induced by administration of pharmacologics have been used for many years to monitor biochemical changes both of disease progression and the changes induced by drug activity. But now that esoteric laboratory work has a new name and this phenomenon of increased, innovative utilisation of the laboratory has taken on a life of its own – zealots are everywhere. They’re in laboratories where biomarkers began.

They’re in sales where they see biomarkers as a market differentiator. They’re in senior administration where they see biomarkers as emphasising their scientific prowess. They’re certainly in clinical management where they see biomarkers as a tool to ‘fail fast’ or for ‘proof of concepts’ depending on whether they’re pessimists or optimists. So the statement in the first paragraph regarding the ‘others affected’may be incorrect – there are no ‘others,’ we’re all zealots.

BIOMARKERS IN DRUG DEVELOPMENT

Unlike other revolutions, in the case of biomarkers, sceptics don’t seem to exist; we’re all on the same bandwagon. The questions are who is driving and do we all have the same view of where we’re going? The simple and, probably, correct answer is that we are all driving the wagon. Now, the only issue is to agree on the route to implement change. Even the goal is not in question. While biomarkers will be a key decision criterion in drug development, there’s complete agreement that the patient is the ultimate beneficiary from the clinical application of biomarkers. When biomarkers are successful in documenting drug activity, efficacy or toxicity during the clinical development of an experimental medicine, they must be applied to the individual patient being given that approved drug, and for the same purposes.


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Lawrence K Oliver, PhD, has been with Mayo Clinic in Rochester, Minnesota since 1997. He is the Scientific Director of Mayo Clinical Trial Services, the Director of the Metals Laboratory in the Department of Laboratory Medicine and Pathology, and the Director of the Center for Biomarker Research. Lawrence has more than 25 years of academic and private sector experience including international responsibilities, and previously worked for the Upjohn Company as Director of the Clinical Research Laboratories. He received his BS from California Institute of Technology and his PhD from Stanford University, after which he did postdoctoral work at the Mental Health Research Institute of the University of Michigan. Lawrence is a fellow of the National Academy of Clinical Biochemistry and author of numerous peer-reviewed articles. He teaches and lectures extensively on the biological and clinical validation of biomarkers.
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