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 has been increasingly battered by rising R&D costs, reduced funding, weak ROI, regulatory challenges, social and political pressure for price controls, a tarnished public image, and a relentlessly competitive market. It depends on solid clinical trials for the discovery, development, and introduction of new drugs.

Mounting evidence suggests that the traditional infrastructure of the clinical trial industry is nearing its breaking point. The global community is locked in the battle with emerging diseases, pandemic diseases, and the growth of so-called "superbugs" that are resistant to drugs. On top of that, the population is aging. Global populations threaten to outgrow research and development initiatives in the biopharmaceutical industry. Despite advances in the speed and accuracy of data capture and medical communications, clinical trial data is slower to reach medical professionals and health care decision makers than in the past. Financial investments in clinical trials has not resulted in faster, better, or more efficient drug development. Furthermore, the data often does not meet expectations and utility in terms of validity and demonstration of clinically significant efficacy or superiority, bolstering the growing opinion that the classically structured clinical trial is not flexible enough to meet the needs of today's global biopharmaceutical community.

Pharmaceutical companies, health institutes, and academic researchers are concerned about the relative paucity of significant pharmaceutical advancements, especially when viewed in the context of declining numbers of medical professionals and ongoing volatility in the field of medical care. Not surprisingly, then, adaptive trials are coming of age at this particular point in the history of clinical research—and that adaptive design is both promising and divisive. Proponents point to increased efficiency, improved patient outcomes, and lower costs of adaptive trials, while opponents argue for statistical inconsistency, potentially problematic error rates, and regulatory caution.

Adaptive design is certainly not a panacea. Classically trained researchers are likely to have to change their approach to staff training, trial supervision, regulatory communication, and data capture. And to fully deliver on the promises of adaptive design, special attention must be paid to several key areas, including ethics, finance, regulatory control, methodology, logistics, statistics, and technology. Notwithstanding this, the use of Advanced Global Research in the adaptive design in clinical trials continues to garner support from all corners and levels of a complex industry. The case for the use of adaptive designs in clinical trials is expressed in the simplest way: adequately executed adaptive designs allow the delivery of valid outcome data faster for a lower cost than classically designed clinical trials. Everyone wins.

There is an increasing effort in the use of technologies to streamline the protocol and increase the effectiveness in clinical research. With the help of technology, organizations are cutting costs and speeding up the evaluation process. Technology enables faster data accumulation, and that information can be disseminated in real-time. This can lead to better decision making with respect to protocol, patient recruitment, and test sites.

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