A Case For Adaptive Design in Clinical Trials
The clinical research industry is in danger of reaching the point of diminishing returns.
By some estimates, it is already there.
The global biopharmaceutical industry, increasingly battered by escalating R&D costs and reduced funding, weak ROI, steep regulatory challenges, social and political pressure for price controls, a tarnishing public image and a relentlessly competitive marketplace, is dependent on a robust and impeccable clinical trials industry for the discovery, development, and introduction of new drugs to market.
However, mounting evidence suggests that the traditional clinical trial industry infrastructure is nearing its break point, and the needs of a global community that is locked in battle with emergent disease, pandemic illness, the growth of drug-resistant "super bugs" and exploding - and aging - global populations threaten to outpace the biopharmaceutical industry's research and development initiatives.
To wit, despite advances in the speed and precision of data capture and medical communications, clinical trial data are slower to reach medical practitioners and health care decision makers than in the past.
Money poured into clinical trials has not resulted in faster, better, or more efficient drug development, and data often fall short of expectations and utility in terms of validity and demonstration of clinically significant efficacy or superiority, compounding opinion that the classically structured clinical trial is not sufficiently flexible to meet the needs of the current global biopharmaceutical community.
Drug companies, institutes of health, and academic investigators are all troubled by the relative dearth of significant pharmaceutical advancement, especially when considered against the backdrop of dwindling numbers of medical practitioners and ongoing volatility in the healthcare arena.
It is not surprising then that adaptive trials are coming of age at this particular point in the history of clinical research, and like any youth's transition to maturity, that of adaptive design is at once promising and divisive.
Proponents point out the increased efficiencies, improved patient outcomes and lower costs of adaptive trials, while opponents argue statistical inconsistency, potentially troubling error rates and regulatory wariness.
Certainly, adaptive design is not a panacea.
Classically trained researchers will likely have to change their approach to staff training, trial oversight, regulatory communication and data capture.
And in order to fully deliver on the promises of adaptive design particular attention must be paid to several key areas, including ethics, finances, regulatory control, methodology, logistics, statistics and technology.
However, the use of adaptive design in clinical trials continues to gather support from all corners and levels of a complex industry.
The case for the use of adaptive designs in clinical trials is most simply stated thus: Properly executed adaptive designs enable the delivery of valid outcomes data faster for less cost than classically designed clinical trials.
Everyone stands to gain.
By some estimates, it is already there.
The global biopharmaceutical industry, increasingly battered by escalating R&D costs and reduced funding, weak ROI, steep regulatory challenges, social and political pressure for price controls, a tarnishing public image and a relentlessly competitive marketplace, is dependent on a robust and impeccable clinical trials industry for the discovery, development, and introduction of new drugs to market.
However, mounting evidence suggests that the traditional clinical trial industry infrastructure is nearing its break point, and the needs of a global community that is locked in battle with emergent disease, pandemic illness, the growth of drug-resistant "super bugs" and exploding - and aging - global populations threaten to outpace the biopharmaceutical industry's research and development initiatives.
To wit, despite advances in the speed and precision of data capture and medical communications, clinical trial data are slower to reach medical practitioners and health care decision makers than in the past.
Money poured into clinical trials has not resulted in faster, better, or more efficient drug development, and data often fall short of expectations and utility in terms of validity and demonstration of clinically significant efficacy or superiority, compounding opinion that the classically structured clinical trial is not sufficiently flexible to meet the needs of the current global biopharmaceutical community.
Drug companies, institutes of health, and academic investigators are all troubled by the relative dearth of significant pharmaceutical advancement, especially when considered against the backdrop of dwindling numbers of medical practitioners and ongoing volatility in the healthcare arena.
It is not surprising then that adaptive trials are coming of age at this particular point in the history of clinical research, and like any youth's transition to maturity, that of adaptive design is at once promising and divisive.
Proponents point out the increased efficiencies, improved patient outcomes and lower costs of adaptive trials, while opponents argue statistical inconsistency, potentially troubling error rates and regulatory wariness.
Certainly, adaptive design is not a panacea.
Classically trained researchers will likely have to change their approach to staff training, trial oversight, regulatory communication and data capture.
And in order to fully deliver on the promises of adaptive design particular attention must be paid to several key areas, including ethics, finances, regulatory control, methodology, logistics, statistics and technology.
However, the use of adaptive design in clinical trials continues to gather support from all corners and levels of a complex industry.
The case for the use of adaptive designs in clinical trials is most simply stated thus: Properly executed adaptive designs enable the delivery of valid outcomes data faster for less cost than classically designed clinical trials.
Everyone stands to gain.
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