The Association for Multisite Research Corporations (AMRC) appreciates the opportunity to provide comments regarding FDA’s proposed Expedited Investigational New Drug (IND) Pilot Program. AMRC represents a nationwide network of leading clinical research organizations conducting research across a broad range of therapeutic areas and patient populations. Our members collectively operate 466 research sites across seven countries and engage millions of patients throughout the United States.
AMRC strongly supports the goals of the FDA’s Expedited IND Pilot Program and the broader vision of accelerating the development of innovative therapies while maintaining rigorous standards for participant safety, scientific integrity, data quality, and regulatory compliance. We believe this initiative presents a significant opportunity to strengthen U.S. clinical research infrastructure, improve patient access to clinical trials, and reduce unnecessary delays between drug discovery and first-in-human (FIH) clinical evaluation.
Defining Qualified Research Institutions (QRIs) and eligibility
AMRC recommends that FDA explicitly recognize qualified Phase 1 clinical trial site networks as Qualified Research Institutions (QRIs) or as formal QRI partners within the pilot program. Organizations with demonstrated expertise in early-phase clinical research possess critical capabilities that directly contribute to successful and safe FIH study execution, including participant recruitment, dose administration, safety monitoring, clinical pharmacology assessment, protocol implementation, regulatory compliance, and operational oversight.
Eligibility for QRI designation should be based upon demonstrated scientific, operational, quality, and safety performance rather than institutional category alone. Academic medical centers, healthcare systems, contract research organizations, and multisite clinical research corporations should all be evaluated against objective standards that measure their ability to safely and efficiently advance investigational products from IND readiness through first participant dosing.
Expanding community access through strategic partnerships
The most efficient path to expanding clinical research participation is through the utilization of established research networks that already possess the necessary infrastructure, quality systems, trained personnel, regulatory expertise, and operational capabilities.
Healthcare organizations should not be required to build independent research programs from the ground up to participate in this initiative. Instead, partnerships between healthcare providers and experienced research networks can rapidly expand community access to clinical trials while preserving the high standards required for modern clinical research. Healthcare organizations can focus on patient identification, referral, and engagement while research networks manage study operations, quality oversight, regulatory compliance, and participant protection.
This approach would expand access to clinical research in hospitals, community practices, urgent care centers, surgery centers, dialysis centers, nursing homes, and home-health settings while minimizing administrative burden and implementation costs.
Prioritizing patient access, health equity, and diversity
Patients must remain the primary stakeholder in the implementation of this initiative.
Integrating clinical research into routine healthcare delivery can improve health equity by providing broader access to innovative therapies and clinical trial participation opportunities within local communities. Community-based research participation also improves representation of diverse patient populations, generating more generalizable safety and efficacy data while accelerating the development of new treatments.
AMRC encourages FDA and other stakeholders to explore mechanisms that reduce barriers to participation, including insurance-related constraints and operational obstacles that may limit enrollment opportunities for underserved populations.
Supporting implementation and long-term value
AMRC supports consideration of grant-based or incentive-driven programs that help healthcare organizations offset implementation costs associated with integrating clinical research into patient care settings. Such programs could encourage participation, support workforce development, and expand research capacity while creating measurable accountability for patient access and research engagement objectives.
The investment required to expand community-based research participation would be modest relative to the long-term benefits of accelerating therapeutic development, improving patient outcomes, increasing trial diversity, reducing healthcare costs, and strengthening U.S. competitiveness in clinical research.
Key metrics for evaluating program success
AMRC encourages FDA to evaluate the pilot program using metrics that extend beyond IND review timelines.
Program success should be measured by the complete pathway from IND readiness to first participant dosing, including:
- Site activation timelines
- IRB approval timelines
- Budget and contract execution
- Recruitment performance
- Screening efficiency
- Enrollment rates
- Participant diversity
- Data quality metrics
- Protocol deviation rates
- Safety outcomes
- Time-to-first-participant-dosed
Operational readiness is often the greatest source of development delay, and the pilot program should address these barriers alongside regulatory review efficiency.
Maintaining safety standards and FDA oversight
AMRC strongly supports expedited development pathways only when participant protections and evidentiary standards remain unchanged.
The expedited program should improve efficiency through enhanced collaboration, earlier scientific engagement, rolling review mechanisms, improved operational coordination, and earlier identification of deficiencies. However, it should not lower the standards required to support first-in-human exposure.
FDA must retain independent oversight and final decision-making authority, with QRI recommendations serving an advisory role that strengthens submission quality, operational feasibility, and risk mitigation planning.
Flexible partnership models and technological adaptation
FDA should permit QRIs to demonstrate capability through established partnerships rather than requiring ownership of all operational components, including Institutional Review Boards (IRBs).
Organizations should be permitted to leverage qualified partners provided they maintain appropriate quality agreements, reliance agreements, standard operating procedures, conflict-of-interest controls, audit programs, and oversight mechanisms that ensure regulatory compliance and participant protection.
As clinical research increasingly incorporates remote monitoring technologies, digital endpoints, decentralized trial models, AI-enabled recruitment strategies, automated data capture, translational biomarkers, and advanced clinical pharmacology approaches, regulatory frameworks must remain adaptable.
Conclusion and core recommendations
AMRC strongly supports FDA’s Expedited IND Pilot Program and believes it can significantly improve the efficiency of drug development, strengthen domestic clinical research infrastructure, and expand patient access to innovative therapies.
To maximize the program’s success, FDA should:
- Explicitly recognize experienced Phase 1 clinical trial networks as QRIs or QRI partners.
- Base QRI qualification on demonstrated capability and performance rather than institutional type.
- Leverage established research networks and healthcare partnerships to expand access efficiently.
- Prioritize patient access, diversity, and community-based participation.
- Measure success using quality, safety, operational readiness, enrollment, and access metrics in addition to review timelines.
- Preserve FDA independence, participant safety, and existing evidentiary standards.
- Encourage flexible partnership models that expand capacity without compromising oversight.
AMRC and its member organizations remain committed to collaborating with FDA and other stakeholders to ensure that this initiative expands access to clinical research while maintaining the highest standards of participant protection, scientific integrity, and regulatory excellence.
