Clinical research organizations (CROs) play an important role in the design and execution of first-in-human (FIH) clinical trials.
FIH studies are the initial step in the drug development process, in which investigational new drugs are tested on human subjects for the first time.
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CROs —in close collaboration with clinics having dedicated phase 1 units— provide comprehensive services and expertise to ensure the success of these critical trials.
In this article we will review the basic aspects of FIH studies while introducing Sofpromed, a CRO specialized in managing early-phase trials with healthy volunteers in a dedicated phase 1 unit situated in Madrid, Spain.
What are First-in-Human Clinical Trials?
First-in-human clinical trials are the first clinical studies conducted on human subjects to evaluate the safety, dosage, and pharmacokinetics of new drugs.
These trials can be categorized as either phase 0 or phase 1 trials, depending on the specific objectives and design.
In phase 0 trials, in vivo data is collected before proceeding to phase 1 trials.
This approach, which is becoming more common, allows for the early assessment of drug behavior in humans.
The Importance of CROs in FIH Trials
CROs specializing in FIH trials offer a range of services that are essential for the successful execution of these complex studies.
In collaboration with phase 1 units, they provide expertise in areas such as study conduct, recruitment and retention, dedicated study teams, and participant safety.
Study Conduct Expertise
Many CROs have extensive experience in conducting FIH trials.
They have conducted several trials in cooperation with phase 1 units and have a deep understanding of adaptive designs that allow for changes based on analysis of human data collected during the trial.
Their efficient electronic case report form (eCRF) build time ensures that data is captured in real time from the beginning of the trial, enabling data-driven study decisions.
Recruitment and Retention Strategies
CROs and clinics with phase 1 units have access to comprehensive participant databases with profiles of over thousands of volunteers from healthy and patient populations.
They employ innovative recruitment strategies using various media channels to ensure the enrollment of full cohorts for FIH trials.
Additionally, CROs have relationships with other hospitals and medical facilities for access to additional patients or special populations, further enhancing recruitment capabilities.
Dedicated Study Teams
CROs and phase 1 units assign dedicated cross-functional study teams to handle every aspect of FIH trials.
These teams manage all activities, including coordination with third-party vendors, ensuring that safety and bioanalytical data are ready for dose escalation meetings, and aligning study decisions with critical milestones.
Clinics with phase 1 units have dedicated physicians, nurses, pharmacology experts, and technicians focused on ensuring the correct execution and analysis of FIH studies.
CROs leverage proprietary scheduling systems and custom-designed information sharing platforms to maintain alignment and facilitate communication.
Participant Safety Measures
CROs and phase 1 units prioritize participant safety and implement rigorous safety procedures in their operations and facilities.
They conduct feasibility and risk assessments throughout the trial, with daily assessments by investigators.
Phase 1 units located in or close to major hospitals and emergency departments further enhance participant safety.
The Design and Execution of FIH Trials
The design of FIH trials is tailored to the specific objectives and characteristics of the investigational drug.
CROs and phase 1 units work closely with sponsors to develop the most appropriate study design, taking into consideration factors such as safety and pharmacokinetics.
Phase 0 trials typically involve a small group of participants, ranging from 5 to 10 individuals, and use microdoses that are significantly lower than the therapeutic dose.
These trials may include patients instead of healthy volunteers and can replace large animal model studies, reducing the need for extensive animal testing.
Imaging techniques, such as nuclear or fluorescence imaging, can provide valuable visual and biodistribution data during phase 0 trials.
The execution of FIH trials involves multiple steps, including assessing the suitability of the compound or product for FIH studies, designing the study, meeting regulatory guidelines, and submitting an investigational new drug (IND) application.
CROs assist with quality control, protocol development, regulatory interactions, documentation preparation, patient recruitment and screening, imaging acquisition and analysis, onsite monitoring, adverse event reporting, data analysis, and more.
The Outcome and Benefits of FIH Trials
The outcome of FIH trials is a proof of concept for the investigational drug.
These trials provide valuable data on target binding, off-target accumulation, pharmacokinetics, and biodistribution, which inform subsequent clinical trials.
FIH trials, particularly phase 0 trials, can significantly reduce the time and cost of drug development by allowing early go/no-go decisions based on visualized data.
By conducting FIH trials, sponsors can identify promising candidates and optimize the drug development pathway.
Examples of FIH Trials
FIH trials span various therapeutic areas, including infectious diseases, oncology, neurology, and cardiology, among others.
For example, CROs have played pivotal roles in the first-in-human trials of mRNA vaccines, such as the COVID-19 vaccines.
These trials utilized imaging techniques to visualize the behavior of the vaccine in the body and identify promising candidates quickly.
Additionally, CROs are involved in FIH trials for oncology drugs, where the goal is to evaluate safety, dosage, and preliminary efficacy in cancer patients.
Clinical research organizations and clinics with dedicated phase 1 units are indispensable partners in the successful execution of first in human clinical trials.
Their expertise in study conduct, recruitment and retention, dedicated study teams, and participant safety ensures the smooth progress and accurate evaluation of these trials.
By leveraging the services and capabilities of CROs and phase 1 units, sponsors can optimize the development of investigational drugs, ultimately improving patient outcomes and advancing medical science.
Sofpromed offers comprehensive FIH study management services in close collaboration with a highly experienced phase 1 clinical trial unit in Madrid, Spain, which is a great option to conduct FIH studies with the highest quality standards at an affordable price.