Supporting Early Phase Oncology Research with the Right Data Management System

Contributing Expert at Medrio: Rod McGlashing, Data Science Subject Matter Expert

Innovating in early phase oncology trials requires the right oncology clinical data management system. A solution that can successfully balance the growing complexity of oncology research without risking compliance, budgets, or timelines. 

Experts estimate that global spending on cancer medicines will grow to $375B by 2027. Meanwhile, the number of oncology trial starts is reaching historic highs. Between 2018 and 2022, there was a 22% increase in oncology trial starts, of these trials 41% were Phase I.

At the same time, the research itself is changing. Oncology research is expanding into new key mechanisms, targets, and cancer types. 

According to McKinsey and Company Playing to Win in Oncology, there is more importance being placed on precision medicine, distinct cancer phenotypes, patient populations, and availability of therapy choices. 

Regulatory bodies are also pushing for speedy trials and dose optimization. Sponsors embarking on early phase oncology research need to be able to make rapid protocol amendments and check for errors in real time, all while adhering to study timelines.

Explore this article to understand:

Re-imagining Oncology Research Approaches

Oncology research and development is accelerating and evolving, as evidenced by recent regulatory initiatives. 

For example, in 2023, the European Cancer Research Commission launched Groundshot to “set out an evidence-driven, patient-centered cancer research roadmap for Europe.” Its goal is to achieve 70% average 10-year survival for all European cancer patients by 2035. 

Meanwhile, the FDA has rolled out initiatives to:

  • Speed up cancer research through accelerated approvals
  • Improve patient outcomes through optimal dosing
[Image] Initiatives Advancing Innovation in Oncology Trials - Groundshot, Project Frontrunner, and Project Optimus

Accelerated approval pathways in oncology

While randomized controlled trials remain the gold standard, the FDA recently released draft guidance regarding accelerated approval pathways. This approach may be appropriate for sponsors to consider in particular early phase oncology settings.

In the draft guidance “Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutic,” the FDA suggests a shift away from single-arm trials. 

Instead, the FDA advises one of two pathways to support an accelerated approval:

  • Two randomized controlled trials—one with an early endpoint, such as response rate, and another one with a longer-term endpoint, such as progression-free survival or overall survival.
  • One randomized controlled trial supporting accelerated approval while simultaneously testing longer-term endpoints. 

“The sooner we initiate the trial,” Lola Fashoyin-Aje, deputy director of the Division of Oncology 3 in the Office of Oncologic Diseases at the FDA, told The Cancer Letter, “The quicker we can have assurance of the drug’s benefit or the quicker we can withdraw marketing authorization if needed.”

Another initiative emphasizing speed is Project FrontRunner, led by the Oncology Center of Excellence (OCE). 

The initiative is meant to encourage drug sponsors to “consider when it may be appropriate to first develop and seek approval of new cancer drugs for advanced or metastatic disease in an earlier clinical setting rather than the usual approach to develop and seek approval of a new drug for treatment of patients who have received numerous prior lines of therapies or have exhausted available treatment options.”

Improving oncology patient outcomes with optimal doses

Currently, the common paradigm for dose selection is based on cytotoxic chemotherapeutics.

According to the FDA, this approach “leads to doses and schedules of molecularly targeted therapies that are inadequately characterized before initiating registration trials.” It may also lead to a dose selection that is more toxic than necessary for efficacy.

The FDA’s Project Optimus is an initiative aimed at manufacturers to help establish an optimal dose before progressing to registrational trials. There is a need to steward available trial subjects to optimally dosed therapies that are safe and efficacious for as many patients as possible.

Enabling High-Quality Data Collection in Early Phase Oncology Research

Given the rapid changes within research, companies need the right technology to collect clinical data in early phase oncology trials effectively and securely. 

While many technologies can be used in an oncology trial, employing a robust clinical data management system (CDMS), also known as an electronic data capture (EDC) system, can set researchers up for success in building faster, robust trials. 

Oncology trials need a system capable of supporting:

  • Rapid adjustments due to protocol amendments
  • Real-time error-checking
  • On-schedule studies

Supporting protocol changes for oncology trial participants

Many new cancer therapeutics rely on working with the immune system to target tumors, opening up precision medicine opportunities within oncology research. This type of clinical trial requires close monitoring of how a patient is responding, with frequent shifts to a different protocol or therapies.

For modern early-phase oncology clinical trials, sponsors require the right tools and processes to quickly react to the in-stream, patient-specific modifications required.

Sponsors should look for an adaptable CDMS/EDC solution that can support:

  • Expected multiple mid-study updates 
  • Fast turnarounds related to protocol amendments
  • Multiple sites with different cadences on acceptance of a protocol amendment
[Image] Tip for supporting protocol changes - Ask your CDMS/EDC vendor how features like form rules, subject status rule, and group and subgroups can help capture the complexity of a participant’s trajectory of care within a trial.

Preparing for real-time error-checking

In November 2023, the FDA issued a final guidance document, “Real-Time Oncology Review (RTOR) Guidance for Industry”. 

This new approach allows the FDA to “conduct a preliminary review of the data from the pivotal trial(s) earlier in the review process before the applicant formally submits the complete application.” The goal of this pre-analysis is to identify data quality and potential review issues early on.

Of course, this requires sponsors to collect adequate data early on to “demonstrate substantial improvement on a clinically relevant endpoint(s) over available therapies.” 

The right CDMS/EDC can support RTOR with:

  • Targeted monitoring to address efficacy and safety in real time as a study progresses.
  • Custom queries set up to email sponsors immediately of Serious Adverse Events.
  • BYO/ABYO schedulable reports that can be emailed out to stakeholders periodically to get a pulse on the study.
[Image] Tip for preparing for real-time error-checking - Ask your CDMS/EDC vendor how features like monitoring workflows, query processing, and advanced reporting can help maximize data quality and operational efficiencies.

Adhering to early phase oncology study timelines

Delays in oncology research can have serious impacts on profitability and, more importantly, participant lives. Sponsors should look for technology that supports efficient builds to quickly create an effective clinical research database.  

To adhere to study timelines, sponsors need a fully integrated CDMS/EDC solution.

A robust research toolset allows for seamless in-stream modifications and better, cleaner data that can get to a reviewer faster. The right solution supports faster decision-making, higher data quality, and improved patient engagement. 

A CDMS/EDC best fit for early phase oncology trials should integrate with:

  • eConsent to support rapid and accurate re-consent by automating time-consuming manual processes.
  • eCOA/ePRO for higher participant compliance, improved regulatory compliance, reduced operational costs, and to drive reimbursement.
  • Randomization & Trial Supply Management (RTSM) to ensure the right shipment containing the right IP from the appropriate source is generated at the right time. 

Other common solutions that a purpose-built CDMS/EDC should be able to integrate with include imaging and adjudication solutions, safety and pharmacovigilance databases, and other third-party data sources.

[Image] Tip for adhering to study timelines - Ask your CDMS/EDC vendor how eConsent, eCOA/ePRO, and RTSM can help your oncology trial stay on track.

The Future of Early Phase Oncology Research

Oncology drugs in Phase I have a 3.4% chance of ultimately receiving FDA approval. But as the understanding of cancer biology evolves, so will clinical trials. 

Research is changing rapidly and companies need a data capture strategy built on the right technology foundation to keep up with increasingly complex and rapidly changing treatment paradigms.

A fully integrated tech stack will support the mid-study protocol changes, along with meeting the regulatory push for RTOR and faster studies. 

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