With 50% of phase III studies resulting in failure, Aptiv Solutions outlines the real value of taking an adaptive approach to product development and trial design.

Aptiv Solutions is a global biopharmaceutical and medical device development services company, and the market leader in design and execution of adaptive clinical trials having supported over 100 adaptive trials across all phases of clinical development in a wide selection of indications/patient populations in multiple geographies.

The company offers clients an extensive portfolio of innovative services including innovative trials design, translational research services, regulatory services, pharmacovigilance, clinical staffing and the operational support of a global clinical research organisation. Aptiv Solutions has over 850 professionals in North America, Europe, the Middle East and Japan.

The momentum for innovation and change
Driven by the frightening statistic that 50% of phase III studies still fail, the product development process is undergoing significant change and innovative trial design takes centre stage in creating the momentum for change. The 50% failure rate is a statistic that the pharmaceutical industry cannot endure.

"The objective of an adaptive design trial is to generate high-value clinical data to drive 'smarter' product development decision-making."

Innovation through design and execution of adaptive trials
Adaptive trials represent the major route through which innovative trial design is being integrated into product development strategies.
Adaptive design trials offer the greatest potential for changing the product development paradigm.

Creating efficiency and value - generation of high-value clinical data
The objective of an adaptive design trial is to generate high-value clinical data to drive 'smarter' product development decision-making. This is done through the implementation of an interim analysis step (or steps) at which one of several pre-planned trial design adaptations are executed. It is important to note that trial validity must be preserved through the use of appropriate statistical methodologies developed for adaptive design studies - and embodied in agency guidance. Design adaptations enable a much more efficient trial to be conducted and, if implemented throughout a development programme, can save time, money and increase the probability of success at phase III.

The ethical imperative
Sponsor companies are duty bound to protect patients from treatments and interventions that are ineffective, unsafe or cause harm. Pre-planned mid-study adaptations afforded by appropriately designed adaptive trials provide the best mechanism to optimise treatment and safeguard the welfare of patients, without compromising trial integrity and validity. In the majority of cases conventional trials do not permit this and as such should only be used where an adaptive approach is impractical.

Critical success factors for innovative adaptive trials
Successful execution of adaptive trials requires three critical components - people, technology and process:

• people: expertise and experience in design and implementation of adaptive trials
• technology: an integrated execution platform
• process: SOPs and work practices that support advanced data cleaning and data driven monitoring.

Adaptive trials represent the major route through which innovative trial design is being integrated into product development strategies. They offer the greatest potential for changing the product development paradigm.	AptivAdvantage™ is a new integrated technology platform specifically designed for the execution of adaptive trials, although it is finding significant utility in the efficient delivery of traditional trials.

The Aptiv Solutions Innovation Center
Aptiv Solutions created the Innovation Center to improve the conduct of drug development using adaptive trials. The Innovation Center comprises the world's leading experts in novel design methodology and adaptive trial execution, who are driving innovation in product development and are available to assist sponsor companies in trial design and execution.

"Aptiv Solutions' Innovation Center comprises the world's leading experts in innovative design methodology and adaptive trial execution, who are driving innovation in product development."

Aptiv Solutions has the necessary breadth of expertise and knowledge within the organisation to assist sponsor companies in mapping where, when and how an adaptive design can add value to a product development programme. Implementing an adaptive strategy across a portfolio of products can be achieved in a stepwise fashion and can be undertaken by the Aptiv Solutions Innovation Center in conjunction with additional product development and regulatory experts.

Complex adaptive trials are now feasible
Through the use of AptivAdvantage™, sponsor companies have the capability to implement complex adaptive design trials employing novel design methodologies - enabling them to learn significantly more about their development product and make more-informed decisions on subsequent development.
Population enrichment methodologies for confirmatory studies have been recently embodied in fully validated adaptive design software called ADDPLAN® PE. The application of this innovative adaptive approach will dramatically enhance the ability of sponsors to realise the true potential of targeted therapy with the ultimate objective of improving patient care and reducing healthcare spending.

Implementing an adaptive strategy for your company's product portfolio
Devising an innovative trial strategy across a portfolio of products, whether for a single therapeutic area or across several disease states, is a critical step in understanding the value that adaptive design can create.

Aptiv Solutions has the necessary breadth of expertise and knowledge within the organisation to assist sponsor companies in mapping where, when and how an adaptive design can add value to a product development programme, whether it's a drug, medical device or combination product. The real value of an adaptive approach is realised when it's applied across the whole development programme from phase I to phase IV.