The significance of biomarkers as diagnostic and predictive tools with clinical utility and for monitoring and judgment of study progress probably cannot be overestimated. Co-development and extended use of biomarkers throughout the entire drug development process, referred to as `companion diagnostics´, are considered to yield significant increases in study effectiveness. Ioannis Amarantos, Thomas Laufer and Thomas Brefort of Febit Biomed GmbH explain how integrative, combinatorial approaches assessing multiple genomic biomarkers will potentiate the power and complement cellular, protein and metabolic biomarker data.
“Comparative effectiveness” has become a popular phrase in political and health policy circles worldwide since the US Congress passed the Patient Protection and Affordable Care Act of 2010.
The current interest in comparative effectiveness research is driven by the desire to identify treatment options that are more effective than others and offer good “value for money”. While head-to-head research can yield valuable insights on effectiveness and cost-effectiveness, care must be taken to ensure comparability across the populations studied. Mason W Russell of PharmaNet discusses that once this data is collected, it can be used in conjunction with costs and other economic data within a modelling framework to estimate cost-effectiveness and budget impact of treatment options.
Clinical development plans require efficiency, expertise and agility in a rapidly changing regulatory and treatment environment. Meghann Smith and Kathy Burruss of Ockham explain the major points of consideration regarding the ability to strategically guide compounds through the clinical development process in a cost-effective manner by utilisation of a niche oncology CRO.
The cost of patient enrolment is now the single largest part of the total trial budget, representing 32% of the cost. Among CROs and sponsors, this expense has been accepted as the inevitable cost of trial management, but it no longer should be. Richard Malcolm of Acurian considers what impact the emerging CRO/sponsor strategic partnerships that represent the latest trend in the CRO industry will have on patient enrolment.