Oncology clinical trials are at the forefront of medical research, paving the way for innovative treatments and advancements in the fight against cancer. Early phase clinical trials, specifically Phase I and Phase II, are the critical first steps in evaluating the safety and efficacy of new cancer therapies. However, conducting these trials is not without its challenges. In this blog, we will explore the current challenges faced by sponsors, clinicians, trial sites, and CROs.

1. Patient Recruitment and Eligibility

One of the most significant challenges in early phase oncology trials is recruiting and enrolling eligible patients. Many trials have strict inclusion and exclusion criteria, along with the large number of ongoing cancer trials, which can make it difficult to find suitable participants. Additionally, patients may be hesitant to participate in early phase trials due to concerns about the experimental nature of the treatments and potential side effects. Patients may often be excluded by lack of trials available in their local community-based hospitals. This can lead to delays in trial initiation and completion. Sponsors may overcome this by utilizing CROs that have a diverse network of sites, actively engage sites and focus on identifying patient populations early in trial design.

2. Biomarker Identification

Advances in precision medicine have led to an increased focus on identifying biomarkers that can predict treatment responses. However, identifying relevant biomarkers for specific cancer types can be a daunting task. Researchers must grapple with the complexity of tumor biology and the need for robust biomarker assays to guide patient selection and treatment strategies.

3. Small Patient Cohorts

Early phase trials typically involve small patient cohorts, making it challenging to draw statistically significant conclusions. Small sample sizes can lead to variability in results and difficulties in assessing the true efficacy of a treatment. Researchers must carefully design trials to address these limitations and consider alternative trial designs, such as adaptive and basket trials.

4. Regulatory Hurdles

Navigating the regulatory landscape for early phase oncology trials can be a formidable obstacle. Researchers and sponsors must navigate complex guidelines set by the FDA, including the new guidelines detailed in Project Optimus. The regulatory process can be time-consuming, requiring extensive documentation and data collection, which may delay the progression of promising therapies to later-phase trials. Seeking guidance from regulatory experts can help identify and mitigate risk earlier in the process. Partnering with a CRO who specializes in oncology-specific regulatory strategies can improve the timeline for IND submission and trial initiation.

5. Data Management and Analysis

The volume of data generated in early phase trials, including genetic and molecular data, can be overwhelming. Robust data management and analysis tools are essential to derive meaningful insights and make informed decisions about treatment efficacy and safety. Time on treatment analysis, data review on responders, early detection of efficacy, and biomarker and surrogate marker trends analyses can help make critical decisions in trial or cohort expansion.


Early phase oncology clinical trials play a pivotal role in advancing cancer care by testing new therapies and treatment strategies. However, these trials are not without their challenges, from patient recruitment and regulatory hurdles to the complexity of trial design and data analysis. Addressing these challenges requires collaboration among researchers, clinicians, sponsors, CROs, and patients. By overcoming these obstacles, we can continue to make strides in the development of innovative and effective cancer therapeutics.


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