When a Cure Can’t Wait: 4 Ways that Central Labs Accelerate Oncology Trials

Oncology clinical trials are different. They have complex trial designs and with advanced treatments only getting more precise, the complexity will continue to increase. Oncology trials demand thorough attention to detail and a streamlined process to ensure that promising therapies reach patients swiftly and safely.

The time required for a drug to be tested and approved has no standard timeline. Completing all phases of oncology trials can take anywhere from 10 to 15 years. However, this duration can differ significantly depending on various factors.

To help accelerate trials, central labs offer innovative solutions that enhance the efficiency and reliability of the study. By providing sponsors access to the right testing, sample management options, integrated datasets, and scientific expertise, central labs not only accelerate the pace of these trials but also uphold the rigorous standards essential for regulatory approval.

 

Navigating the Phases and Challenges of Oncology Clinical Trials

Oncology trials are designed to evaluate the safety, efficacy, and optimal usage of novel therapies for specific indications, offering hope to the millions of people affected by cancer. These trials are broken up into four phases:

• Phase I: focuses on determining the safety and appropriate dosage of a new treatment in a small group of patients
• Phase II: assesses the treatment’s efficacy and side effects in a larger cohort
• Phase III: involves extensive testing on a larger patient population to confirm effectiveness, monitor side effects, and compare the new treatment to standard therapies
• Phase IV: assesses long-term safety and effectiveness in a broader patient population after the treatment has been approved

The path to developing effective oncology treatments has its unique challenges. Patient recruitment is often a significant hurdle, as finding suitable candidates who meet the specific criteria for each trial can be difficult and may require broad reach across geographies. Additionally, the diversity of cancer types and variations in patient responses add layers of complexity to these trials. Precise data collection is extremely important when it comes to ensuring accuracy and reliability. Overcoming these challenges necessitates a combination of experience and scientific expertise, enabling researchers to design robust trials and interpret complex data.

 

How Central Labs Can Accelerate Oncology Trials

1. Central labs can accelerate oncology trials by providing investigator sites with a streamlined approach to the collection and processing of lab samples. This enhances the reliability of results and reduces the time between sample collection and data analysis, expediting the overall trial timeline.
2. Superior sample management is another component a leading central lab can bring to oncology trials. They coordinate the timely transportation of samples from diverse investigator sites to the lab and may utilize advanced tracking systems that monitor the status and location of each sample in real-time. This ensures that samples reach the lab safely and promptly, minimizing the risk of delays or losses that could compromise the trial.
3. This ties into the standardized data management that central labs can provide. By adhering to strict standards, central labs ensure the consistency and high quality of the data obtained during the trial. This allows for the efficient management of large volumes of data from various sources that must be harmonized.
4. Lastly, sponsors can tap into individuals with deep expertise in oncology studies by partnering with a central lab that offers Functional Service Provider solutions. FSP experts apply their knowledge to interpret complex data, guide assay development, and ensure that the latest scientific advancements are incorporated into the trial processes.

 

A Real World Oncology Trial Acceleration

The complexity of oncology trials often demands globally consistent and customized sample processing. For one LabConnect client, this included the processing of circulating tumor DNA (CtDNA) and peripheral blood mononuclear cells (PBMCs) across a broad geographic area, with close monitoring of logistics lanes while samples were in transit. The protocol also required handling multiple sample types, including fresh tissue biopsies, which involved crossing international shipping lanes. Ensuring the integrity and timely delivery of every subject sample was critical to the project’s success.

LabConnect’s Global Sample Processing Network (GSPN) provided an effective solution to these challenges. By implementing consistent processing protocols in each region, LabConnect ensured maximum sample viability. Our logistics team offered real-time oversight for shipments, mitigating the risk of sample delays during transit across borders. Our regional services and logistics monitoring prevented the loss of samples, resulting in no delays to subject enrollment or dose escalation cohorts.

As we look to the future, oncology trials promise even greater efficiency and success rates, supported by the advancements and expertise offered by central labs. The combination of streamlined trial support and scientific expertise will continue to enhance trial precision, reliability, and speed, bringing life-saving therapies to patients faster.

Ready to find a cure for your complex challenge? Learn how LabConnect’s expertise can accelerate your Oncology trial.