A systems approach to enhance clinical research and medicines development

Abstract

Abstract:The biopharmaceutical industry has traditionally been the key link between basic biomedical discovery and novel medicines. Today, the industry faces numerous challenges including the broad agreement that the current clinical trial system is inefficient and flawed. Most challenges are worsened by the inability of the stakeholders to work collaboratively. Over the last decade, many cooperative efforts to transform clinical research have been launched, but a systemic solution has not been envisioned. A systems approach, including the application of systems engineering principles, has been used in other sectors and proposed for use in healthcare and medicines development. Clinical research, when looked at in systems terms, can be defined as an open system involving patients, investigators and associated staff, regulators, sponsors and stakeholders interconnected through a series of processes to bring effective and safe medicines into the market. ACRES is a global nonprofit organization with a mission of creating a multi-sector alliance of individuals and institutions collaborating on building a shared global system for clinical research excellence. A fundamental element of the ACRES system includes a global network of high-performing research sites interconnected through a shared information technology platform, with standardized policies and operational procedures and a robust, secure database to support performance, quality and safety. Five core initiatives address the larger mission and are currently ongoing. Deliverables will roll out over 2015-2018. Positive reception to the concept, vision and goals among critical stakeholders, and a steady influx of strategic allies willing to work collaboratively demonstrates the strong pull exerted by the vision of a global system. However, due to the undertakings' scope and complexity, challenges remain. Recognition that effective shared collaboration is the best long-term option among stakeholders and the general public constitutes a powerful incentive for ACRES contributors and strategic allies to keep working and make it happen.

First‐in‐Human, Healthy Volunteers Integrated Protocol of ETC‐206, an Oral Mnk 1/2 Kinase Inhibitor Oncology Drug

“…), which is fully unfolding in current times. [1][2][3][4] The transformation has been driven by multiple factors 1,3,[5][6][7] and has spread across all clinical phases tackling common and specific issues 2,7 of early (i.e., phases I and II/proof of concept) and late (i.e., phases III and IV) stages. 2,4,7,8 We report and discuss the use of integrated protocols in first-in-human (FIH) studies with healthy volunteers (HVs) and oncology drugs.…”

Editorial: Grand Challenges in Pharmaceutical Medicine: Competencies and Ethics in Medicines Development

“…as components interconnected through a series of processes aimed to bring effective and safe medicines into the market and maintain them. Because of the above a systems approach integrating research into healthcare system s has been proposed to overcome the current barriers to a cost/effective cooperative process and appropriate management of the risks involved ( Meadows, 2008 ; Johnson et al, 2014 ; Silva et al, 2015 ).…”

A medicine adoption model for assessing the expected effects of additional real-world evidence (RWE) at product launch

“…Modelling and optimising engagement with these gatekeeper groups may lead to more patients receiving the benefits of new medicines sooner. Under systems theory 1 the adoption of a medicine can be modelled as an open system that interacts with its environment. Within this system, the three gatekeepers exist as subsystems, each employing their own "black box" logic to inputs they receive to generate their output of a decision which, if favourable, allows the medicine to progress to the next subsystem in the series (Figure 1).…”