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