Industry must take advantage of "lessons learned."
Several years ago, the Board of Directors of the Association of Clinical Research Organizations (ACRO) decided to expand the boundaries of membership to welcome not only CROs but technology companies as well. This recognition that the software and platforms provided by technology companies are increasingly integral to the design, execution, and analysis of clinical trials reinforced the association’s long commitment to innovation in clinical development, and today ACRO’s membership is roughly half CROs and half technology companies. The mission of ACRO—to advocate for a positive and consistent regulatory and business environment in which companies that perform a wide range of clinical development activities can operate worldwide—did not change. But our voice became larger and more diverse.
In supporting clinical development projects from beginning to end, CROs and technology providers have a unique vantage point, interacting with all the stakeholders in the enterprise: sponsors, investigators, institutional review boards (IRBs) and ethics committees, research sites, research participants, and regulators.
This unique perspective on the research environment affords opportunities for data collection, and in 2020 and 2021 ACRO undertook landscape surveys of risk-based monitoring/risk-based quality management (RBM/RBQM) implementation and a preliminary evaluation of the deployment of remote and other tools in decentralized trials (DCTs) across some 6,000 clinical trials annually. Clearly, RBQM and DCTs are hot topics for everyone in the industry—and, importantly, the ACRO landscape surveys go beyond stakeholder opinions or perceptions to gather data on actual adoption at the individual trial level.
We think that is an important contribution that ACRO can make, and aim to continue yearly assessments of RBQM and DCTs and other emerging approaches to improving the conduct of clinical trials.
Beyond gathering data to characterize the current landscape, CROs and technology companies invest heavily in innovation and thought leadership, and ACRO harnesses collaboration across member companies to produce knowledge and tools that can benefit all stakeholders. For example, our DCT toolkit provides a detailed analysis of design and execution considerations in undertaking a DCT, as well as a risk-assessment tool and maps that illustrate how data is gathered, transmitted, accessed, and protected in DCTs, an important consideration for regulators, patients, and others.
Another topic on which the CROs and technology companies will lead in the future is the use of real-world data/real-world evidence (RWD/RWE), which will not only provide more fulsome data for drug development, but ultimately could help to begin bridging the gap between clinical research and clinical care.
The COVID-19 pandemic very much highlighted the need for our entire industry to improve diversity and inclusion (D&I) in clinical research, and ACRO member companies are addressing D&I issues on every level, from patient and workforce recruitment to engaging with regulators and legislators on the development of policies that will support and incentivize a fairer and more equitable research environment.
COVID also proved the enormous adaptability and resilience of all the stakeholders in the clinical research enterprise; overall, CROs and technology companies, sponsors, sites, patients, IRBs, and regulators rose to meet the extraordinary challenges of a worldwide pandemic. ACRO and its member companies are determined to take advantage of the “lessons learned” over the last two years—and we look forward to a bright future for drug development.