Dr. Jonathan Seltzer, President & CEO
In clinical studies where endpoints are perplexing or subjective to evaluate, an Endpoint Adjudication Committee comprised of clinical specialists is set up to review clinical data in order to give expert opinions about safety or efficacy events of interest. Endpoint Adjudication can be a critical aspect of a clinical trial as it can help to reduce variation in important outcome events for submission to regulatory agencies.
Specializing in Adjudication Committee management, ACI Clinical brings clients the largest and most experienced dedicated committee staff, a global network of 500 skilled medical thought leaders who can serve as committee members or expert advisors to clients, and a proprietary technology designed specifically to ease adjudication workflows. “We spent over 5 years thoroughly researching and understanding the adjudication workflow process prior to designing our AIMS enterprise adjudication system” says Dr. Jonathan Seltzer, President and CEO of ACI Clinical. “We believe that our system, in addition to being highly cost-effective, helps to optimize each step of the process and reinforce best practices.”
Dr. Seltzer’s affiliation with regulators and academicians has created additional awareness around the struggle of adapting traditional Electronic Data Capture (EDC) products for endpoint adjudication. Typically, the reason is standard clinical trial protocols have a set schedule of events and the associated data management process or EDC is programmed accordingly. “In real-time adjudication, one never knows when, how many or what types of adjudication events will occur” says Dr. Seltzer. He adds “Many of our partners and clients initially attempted to manage their own adjudications, but ultimately realized greater efficiencies outsourcing to a dedicated niche specialist with the proper expertise to manage the complex workflows required.”
As an unbiased third party, ACI is entirely independent from a clinical trial’s operations, making them well-positioned to facilitate smoother collaboration between sponsors and adjudicators.
We specialize in Endpoint Adjudication Committees and Data Monitoring Committees, clinical and safety consulting, and full-service biometrics solutions.
ACI’s ongoing relationships with its committee members has helped the company design its services and systems in a user-friendly fashion that reduces administrative encumber and system navigation time, which is highly rated by adjudicators, evidenced in recent survey results.
The company also specializes in the planning and management of Data Monitoring Committees that harmonize with Food and Drug Administration (FDA), European Medicines Agency (EMA) and International Council on Harmonization(ICH) guidance on establishing and operating DMCs. “Providing helpful information to a DMC is a unique challenge as we have to make unmonitored and incomplete data decision-able,” asserts Dr. Seltzer. “Our experienced teams work closely with our clients to identify and recruit the proper clinical and statistical experts while simultaneously preparing the data package presentation in an ‘easy-to-evaluate’ clinician fashion rather than just CSR tables.” Recently, the FDA released a new draft Drug Safety Guidance document recommending the use of Safety Assessment Committees (SAC) to oversee and report on patient safety data throughout a drug’s development program. ACI’s in-house experts are now assisting clients with these new safety reporting requirements and building up a SAC solution customized to meet their distinctive drug development needs.
The company is excited about its AIMS 4.0 launch by end of 2016, which will further improve efficiency and cost-effectiveness of endpoint adjudication, especially important in trials for which there will be relatively few cases to be adjudicated. For the future ahead ACI is keen to explore the use of adjudication as a component of risk based monitoring and as a quality check on the clinical trial itself. “We are working to offer many innovative opportunities in adjudication to help drive efficiencies in clinical trials while reducing cost, and we will continue to focus on solutions for patient safety and enhancing the integrity of clinical trial endpoints.” concludes Dr. Seltzer.