The pharmaceutical industry is in a state of change. Internally, companies struggle with spiraling development costs and demand for new compounds to fill the void left by expiring patents. Externally, they face the daily challenges of a global economy in crisis – reduced budgets, staff lay-offs, reorganizations, and off-shoring.
Amid this change, one response that has been rapidly gaining ground is the acceptance and use of adaptive design trials as a key component of the clinical development process. An adaptive trial is conducted in stages where interim data is used to plan the next stage of the trial. Drug and medical device developers can use this approach through all phases of clinical development to modify aspects of the study without undermining the validity and integrity of the trial. Regulators in the US and Europe support the use of adaptive design trials, and both the FDA and EMA have published Guidance Documents on the implementation of adaptive design trials.
As the only pharmaceutical and medical device development company to offer design, implementation, and execution of adaptive clinical trials, our goal is to use this blog to educate, inform, and engage readers on the use and value of adaptive design trials in modern day clinical development. To support this important initiative, we have created an in-house Innovation Centre comprising world-leading adaptive trial experts who are available to provide insight into the design and conduct of adaptive trials in which the ultimate objective is to generate high-value clinical data that enables smarter product development decision making.
We look forward to sharing news and information about the rapidly evolving field of adaptive design trials. We will provide education on tools and technologies that are essential for adopting an adaptive approach, and we hope to engage and connect with the growing community of adaptive trial innovators who are integrating this exciting approach into their product development programmes, and who will ultimately benefit from its success.
Aptiv Solutions Blogging Team
