The market for contract research organizations (CROs) in early phase clinical drug research has been growing rapidly in recent years. According to a report by Grand View Research, the global CRO market was valued at US$32.4 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 5.9% from 2023 to 2030.
The rapid growth allowing CROs to emerge as essential partners in the clinical drug research space can be attributed to the increasingly complex and expensive process of running a clinical trial. Their involvement spans all phases of drug development, each of which has its own set of challenges and requirements; however, early phase research, in particular, can bring significant risks for sponsors investing their time and money in a new investigational product. In this article, we explain the purpose of an early phase CRO and explore why they are crucial for maximizing the chances of success in Phase I clinical trials.
What is an Early Phase Contract Research Organization (CRO)?
An early phase CRO is a specialized entity within the clinical research industry that focuses primarily on conducting clinical trials in the early stages of drug development. These early phases, typically Phase I and Phase II clinical trials, are essential for assessing the safety, tolerability, and preliminary efficacy of experimental drugs or therapies in humans. CROs provide research services to the pharmaceutical, biotechnology, and medical device industries, offering a range of services for sponsors, including the following:
Clinical Trial Management: Depending on their contract, CROs can often be responsible for managing a significant portion of the clinical trial process, from recruiting and enrolling patients to managing the study sites for quality data collection.
Data Management: CROs also help ensure that the data collected is accurate and complete, and that it is collected in a timely and efficient manner, typically using specialized software and databases to provide reports to the study sponsor.
Regulatory Compliance: CROs often assist sponsors with maintaining strict regulatory compliance within a study. This includes ensuring that the study protocol is approved by an Institutional Review Board (IRB), that the informed consent process is followed, and that all adverse events are reported to the appropriate regulatory agencies.
Understanding Phase I Clinical Research
The primary goal of early phase or Phase I clinical research is to evaluate the safety and tolerability of a new drug. Researchers aim to determine the maximum tolerated dose (MTD) of the drug, which is the highest dose that can be administered without causing severe side effects. They also seek to identify any adverse effects of the drug and establish the appropriate dosage levels for future studies.
Early phase clinical research typically has two phases:
- Phase Ia involves a single ascending dose study where participants are given a single dose of an intervention and observed for adverse side effects and expected pharmacokinetic activity. The dose is escalated until MTD is reached, which is determined when one-third of participants exhibit severe side effects.
- Phase Ib clinical drug research involves administering different dosages of a new agent to participants in order to test its efficacy. The trial will also typically involve collecting study blood or plasma samples to understand how the body processes the drug.
Early phase clinical research is a crucial stage in drug development as the data generated is used to determine whether a drug should move forward to later phases of clinical trials. If a drug is found to be safe and tolerable in early phase clinical research, it can proceed to larger-scale clinical trials to evaluate its efficacy and effectiveness.
Three Key Roles of an Early Phase CRO
The extent of an early phase CRO’s role in the clinical trial process can vary from study to study, but these are three essential roles they provide to sponsors.
1. First, due to their team of experts who are knowledgeable in niche therapeutic areas and regulatory requirements, early phase CROs can guide sponsors throughout the clinical trial management process to ensure their readiness prior to startup.
2. Second, site selection is a critical process that can be outsourced to CROs, particularly if they already have a database of qualified investigators and study sites that have experience working with early phase clinical trials.
3. Lastly, one of the most important aspects of clinical trials that CROs will assist with is patient recruitment. These organizations have a team of patient recruitment specialists who can identify and screen eligible patients for the clinical trial, working with study sites to ensure that the clinical trial meets its enrollment goals and timelines.
Benefits of Partnering with an Early Phase CRO
Early phase CROs have a team of experts who are knowledgeable in conducting successful clinical trials across specific disease indications. Their scientific expertise can help manage clinical trials for sponsors, providing guidance on trial readiness, patient recruitment, and data management. Early phase CROs also have a deep understanding of the regulatory landscape and can help pharmaceutical companies navigate the complex regulatory requirements.
One of the primary reasons for the growing need for CROs began with the increasing costs required from sponsors to manage the entire clinical trial process. This is especially important for early phase trials where study designs can be more intensive for patients and are required to go smoothly to ensure quality data that allows the product to move into later phase testing. Early phase CROs have the staff, resources, and expertise to conduct Phase I studies more efficiently and cost-effectively than pharmaceutical companies can do on their own.
Most importantly, early phase CROs have experience in managing clinical trials and can help identify potential risks and implement strategies to mitigate them. By partnering with these specialized companies, pharmaceutical companies can reduce the risk of costly mistakes and ensure that the clinical trial runs smoothly and efficiently.
Conclusion
Partnering with an early phase CRO offers several benefits to pharmaceutical companies, including expertise, resources, flexibility, cost-effectiveness, and regulatory compliance. These organizations play a critical role in Phase I clinical drug research by providing pharmaceutical companies with the services they need to conduct clinical trials more efficiently and cost-effectively. As the market for CROs continues to grow, pharmaceutical companies are likely to rely even more heavily on these organizations to help them bring new drugs to market.
Vial is a next-generation, tech-first CRO delivering faster, more efficient trials at dramatically lower costs for biotech sponsors, starting from Phase I. By partnering with our full-service teams across nine therapeutic indications, we are empowering scientists to discover groundbreaking scientific therapeutics that help people live happier, healthier lives. We have built a global, full-service CRO powered by intuitive end-to-end technology with the expertise of innovators, engineers, and ClinOps leaders.
To learn more about how we can streamline your clinical trial start-up process, visit Vial CRO’s website and connect with a team member today!
