Investigator-initiated trials (IITs) involve independent clinical research in which the investigator takes on the sponsor and investigator roles. Designed to empower academic researchers and clinical investigators, Alfa Cytology's complete IIT service features a rapid timeline of just 5-7 months for completion, and provides the necessary expertise and groundwork for the advancement of innovative radioligand therapies (RLTs) and radionuclide drug conjugates (RDCs), allowing the transformation of visionary ideas into robust, actionable information.
Investigator-initiated trials (IITs) are described as trials where clinical studies are conceived, designed, and executed by academics or researchers from a non-pharmaceutical company and are primarily for exploratory clinical research. These studies are paramount for studying the disease therapy for RDCs, evaluation of new combination regimens, biomarker identification, or the mechanism of action. IIT is designed to de-risk and accelerate the transition of targeted radiopharmaceuticals from bench to early clinical validation. This allows rigorous and high-quality scientific research and generates well-designed proof-of-concept studies, data to guide larger registrational trials.
Fig.1 IIT study design for evaluating the clinical value of 68Ga-MY6349 PET/CT. (Chen, H., et al., 2024)
For initiating an IIT, the first step is to submit a specific concept note, followed by a full proposal. After which, a reviewer evaluates each proposal on several key criteria:
| Item | Challenges | Solutions |
|---|---|---|
| Regulatory and Ethical Complexities | Dealing with multi-agency oversight, such as the FDA and NRC, and balancing the regulations of radioactive pharmaceuticals, as well as the peculiar ethical issues and rigorous scrutiny of the ethics boards, is challenging. | Proactive regulatory consultation, comprehensive strategy development, and the formulation of strict data security protocols, supported by expert advisors, to ensure timely compliance and quicker approvals. |
| Financial and Resource Constraints | High costs of radionuclide production, specialized equipment, and specialized personnel, often with limited and highly competitive funding. | Pursuing various funding sources and establishing strategic partnerships to lower development costs and improve the use of available resources. |
| Operational Issues | The logistical complexities of the handling of radioactive substances and the patient recruitment in therapeutic niches. | Developing targeted recruitment strategies and robust supply chain/logistics plans, supported by standardized procedures and advanced data management systems. |
As an extension of your research team, we offer comprehensive and integrated services throughout the entire RDC IIT research lifecycle. This unique model of service enables seamless integration of all your research elements, ensuring that each component of your research, from regulatory strategy and drug supply to total statistical analysis, is more efficient and aligned with the primary scientific goals of the study.
Understanding the needs of investigator-led studies, we offer customized assistance to facilitate the implementation of your research. Our company offers extensive, fully customized, end-to-end IIT services for a wide range of radionuclide drug conjugates, adapting our scientific and regulatory knowledge to the specific characteristics of each targeting modality.
A streamlined and collaborative process makes sure all RDC IIT executions are quick and compliant:
Feasibility & Protocol Design
Starting with an all-encompassing evaluation of the scientific rationale and study feasibility, followed by the preparation of a solid and executable protocol that aligns with the study objectives and scopes of research and regulation.
Compliance Approval
Handling the entire regulatory submission process, including the preparation of required documents, so that all research activities are within ethical and legal boundaries.
Recruitment and Screening
Achieving optimal enrollment and appropriate patient selection through carefully designed patient recruitment and comprehensive screening.
Data Collection
With standardized case report forms and electronic data capture systems, we ensured all study endpoints and safety parameters were documented thoroughly and accurately.
Quality Control
Assuring comprehensive oversight of quality through continuous monitoring, data verification, and compliance with prescribed protocols, as prescribed in the quality management system.
Service Delivery
Reporting on the study results and analyses, with statistical evaluation, for timely and secure results delivery. This supports decisions on publication, further development, and study goals.
Positioning ourselves as a strategic development partner, we aim to help identify the full therapeutic potential of your RDC candidate. Differentiated by a singular focus on the demands of radiopharmaceuticals, we provide exceptional IIT service and expertise.
Focused on facilitating the next level of innovation in targeted radiopharmaceuticals, Alfa Cytology's specialized IIT services offer the essential infrastructure and specialized know-how to translate valuable RDC concepts into clinically validated. For researchers looking for a competent and trustworthy collaborator to conduct a solid and meaningful IIT, we welcome you to talk about your particular research goals and planned study framework. Reach out to us to learn how we can work together to speed up the development path for your RDC.
Reference
For research use only. Not intended for any clinical use.
Alfa Cytology, a provider of RDC preclinical services, specializes in RDC design, conjugation, and analysis. Supported by a rich library of radionuclides, chelators, and linkers, we excel in targeting molecule design. We offer customized RDC services tailored to diverse requirements-your demand is our mission.
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