ACI Clinical: The underestimated value of independent expert committees and their guidance in clinical trials

Clinical trials are now considered as one of the most important disciplines in the healthcare industry. But planning a clinical trial becomes difficult due to regulatory uncertainties, time and cost to approval, the involvement of multiple agencies for direction, and several other factors. Moreover, many interested potential investigators require additional support in fundamental knowledge of regulatory, ethical and GCP guidelines to conduct clinical trials. The quality of global trials and academic clinical research is not uniform, and due to the acute paucity of research funds, very few institutions are engaged in world-class clinical research.

This is where ACI Clinical comes in as a specialty provider to the clinical research industry. ACI was built from the start with a systems approach to organizational quality that is designed to deliver high-value medical expertise to enable timely decision-making that better optimizes clinical trial investments. Through a powerful combination of an expert doctor network, internal core competencies and a technology infrastructure that connects real-time clinical trial data with medical experts across the globe, ACI independently supports Expert Committees that provide oversight to clinical trials. These primarily include Endpoint Adjudication Committees (EAC), Data Monitoring Committees (DMC), and Safety Assessment Programs, supplemented by analytical biometrics and safety consulting capabilities. By applying scientific expertise, operational intellect and regulatory foresight, ACI is proud to support many development programs with its industry-leading expert committee solutions.

Proactive approach to meeting customer needs

There is an increasing need for focused attention towards oversight and evaluation of clinical trial endpoints due to their critical impact on regulatory approvals, commercial labeling, reimbursement and patient care. ACI’s leadership continues to pioneer industry best practices and develop specialized technologies that facilitate Independent Medical Oversight of trial endpoints.

The company utilizes the following methodologies to address client needs -

• Leadership involvement with regulators in private-public partnerships that establish and publish best practices, shape policies and create guidance
• Cultivation of ACI’s global network of prequalified medical and statistical experts as a source of knowledge that can be matched to clinical programs and/or safety signals that occur
• Specialized training for in-house staff that are deeply experienced with the nuances of expert committee operations and impactful deliverables
• Proprietary technology to power the processes that enable timely, accurate data delivery and decision making

Sharing knowledge and experience to benefit clients

Since 2001, ACI has supported over 700 projects with more than a hundred clients from major Pharma preferred partnerships to biotech, device, associations, and AROs/CROs. They regularly poll and hold dialogues with clients, academic experts and regulators to improve processes, relationships and the overall impact of the global research community. Below are a few examples of how ACI supports its clients.

Scalability: Helped a sponsor company scale from a manual Ph2 adjudication process to the AIMS^® infrastructure that now supports 20+ protocols seamlessly across the globe. Facilitated a different sponsor to scale from a small in-house operation to a system-based adjudication process for anticipated growth

Complexity: Helped a sponsor company setup a large DMC with 11 members in multiple continents to oversee a novel high-profile program. For another client, ACI created a system for a large program-level approach with easy onboarding guides for new study teams that ensured process consistency and meaningful reporting across the program over many years

Volume: Setup innovative Adjudication models to support studies with single digit expected events in an affordable manner while delivering regulatory grade quality

Novel approaches: Partnered with an expert network to create and publish Endpoint definitions for companies in new therapeutic areas through a structured process that included regulatory endorsement

Key differentiating factors

Independent, unbiased guidance: As specialists who sit outside the clinical trial, ACI Clinical brings in the independent voice to sponsors, academic experts, and regulators

Advanced medical expertise powered with decision-making tools: ACI excels at empowering their clients with the right medical information at the right time to mitigate risk and ensure patient safety in clinical trials

Deep clinical trial expertise and forward-thinking experts: ACI’s committee-experienced staff with deep process expertise and knowledge can readily advise clients on the best courses of action for their programs

Roadmap of ACI’s future ventures

In the last few years alone, ACI has conducted Expert Committee services for hundreds of studies, doubling the number of new clients each year. In addition, they continue to provide statistical programming and CDISC data conversion services for clinical studies.

ACI projects have ranged from Phase I-IV, in more than 25 therapeutic areas, for pharmaceutical companies, academic centers, biotech, medical device, and diagnostics companies. In order to advance forward, ACI’s next step is the continued development of the industry’s best in class adjudication platform with further applications in high-level medical oversight for safety monitoring, safety/efficacy assessments, and decision-making within the platform.

Knowing the CEO, Dr. Jonathan Seltzer

Dr. Seltzer is a recognized leader in the area of cardiac safety, Endpoint Adjudication Committees and Data and Safety Monitoring Committees. He has chaired and served as a committee member for scores of protocols and has functioned as an advisor for dozens more. He is actively publishing in these areas and participating in thought leadership efforts focused on defining best practices. Currently, Dr. Seltzer is on the scientific programs committee for the Cardiac Safety Research Consortium (CSRC) and the steering committee for the Clinical Trials Transformation Initiative (CTTI). Previously, he served as the president and chair of Trustees for the Academy of Physicians in Clinical Research.

“By combining our core competencies with our strong academic relationships, we focus on providing independent solutions that help to enhance trial integrity for regulatory submissions, the scientific community, and the patients that we ultimately serve.”