April 14, 2006 | A new report says that the clinical trials process must be reinvented to reverse the output decline of the pharmaceutical industry and meet the needs of its patients. That reinvention will be shaped by major advances in information technology. The Cambridge Healthtech Associates report was commissioned by director Mike Goodman and authored by Hermann Mucke, a consultant based in Vienna. [Editor’s note: CHA is a sister company of Bio-IT World.]
Mucke says the pharmaceutical industry’s current output crisis will not be solved by simply throwing more money or technology at the problem. “What the industry needs above all is to totally rethink the concept of clinical trials,” says Mucke. “This requires broad implementation of novel scientific concepts and applied information technologies, all of which are already available. Mucke believes that a bidirectional approach is needed to accelerate clinical development. “Revamping of trial design and truly pervasive modeling and monitoring driven by information technology...need to be implemented in a closely linked fashion.... By the year 2015, the stage would be set for a new world of drug development.”
Mucke cites three factors as shaping the future of clinical trials over the next decade:
• Continuing globalization and individualization, which will increase ethnic diversity of pharmaceutical markets while also seeing greater demand for personalized healthcare
• Increased pressure on corporate margins and shareholder returns, which will motivate the drug industry to develop drugs more expeditiously and predictably
• The ongoing merger between life sciences and IT, particularly in areas of knowledge and process management such as petaflop and distributed computing for biosimulation; pervasive computing and RFID; advanced storage solutions (SANs); process analytical technology; and Web-scale data and text mining
Mucke is encouraged by the “beginnings of in silico simulation of organ function, and the first steps have been taken to create “virtual patients.” These are prime examples of applied systems biology, of a type that combines understanding of molecular pathways with holistic functional models but does not require full-scale “bottom-up” algorithmic modeling, which will be beyond us for quite some time.”
The architecture of clinical trials is also evolving. “Human microdosing, or Phase 0, studies will play a decisive role in calibrating in silico models,” says Mucke. Another major trend is consolidating Phase II and Phase III trials. Goodman outlines the new approach: “If the PK/PD [profile] looks OK, go into humans, then do a collapsed Phase II/III trial and release to the market, in a controlled way, doing a controlled Phase IV.”
Recording and validating patient information in clinical trials will also advance, thanks to RFID chips to validate patient compliance, and Web-based or voice-driven outpatient data capture. “This will lead to the ‘e-trial,’ which will be a quantum leap beyond the current designs which are paper-based and merely IT-assisted,” says Mucke.
Another major trend, according to the report, is adaptive trial design. Whereas few changes are made to ongoing clinical trials today, and those that are driven by safety concerns, Mucke argues that, “in future scenarios, trials need to have flexibility built into their very design. They will incorporate low-level response signatures, such as pharmacogenomic and metabolomic data, on the fly to maximize the information flow and to make it more relevant.”
Featured Report: Mucke, H.A.M. “A New Paradigm for Clinical Development: The Clinical Trial in 2015.” CHA Life Sciences Reports (2005).