Improving Oncology Clinical Trials for Accelerated Approval

Streamlining recruitment and reporting to support advanced oncology drug development

In March of 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics, regarding clinical trial design specific to oncology with considerations to support accelerated approval applications.

The accelerated approval pathway is commonly used for approval of oncology drugs in part due to the serious and life-threatening nature of cancer and because of available intermediate clinical endpoints likely to predict clinical benefit.

The FDA has established accelerated approval pathways for certain treatments for cancer and other serious diseases. In order to qualify for accelerated approval, drug manufacturers must demonstrate that the medication provides meaningful clinical benefit to patients with life-threatening illnesses during their clinical trials.

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Recent news showed the FDA setting a higher bar for accelerated approvals for cancer drugs. According to the FDA, this approval pathway is especially useful when the drug is meant to treat a disease whose course is long, and an extended period of time is needed to measure its effect – like cancer. In order to improve access to clinical trials, it is necessary to investigate current oncology insights related to trial participation and start with that baseline data, but that itself can prove difficult.

The FDA also released a study on the efficacy of direct-to-consumer advertising and what medical impact metrics could be effective to measure in oncology trials. The FDA will use clinical endpoints to determine whether an oncology intervention is benefitting patients.

It’s known that clinical trials are a crucial element of accelerated approval for oncology medications by the FDA. However, due to low trial participation rates, access to oncology trials is highly limited, creating additional disease burdens for patients and health disparities for vulnerable communities.

Safe & Speedy Drugs to Market

Like with all drugs, the goal is to evaluate the safety and effectiveness of new treatments, but typically the overall survival endpoint is defined as the average length of time the patient lives after starting treatment.

This is the “gold standard” for oncology patients because oncology patients are typically very adherent to treatments they believe will help them live longer. What the FDA did was to use other clinical endpoints to show benefit to the patient. Two common endpoints for oncology are: proportion of patients whose cancer shrinks or disappears and the average length of time after the start of treatment that a patient is alive or the cancer doesn’t spread.

So it’s very complicated to even show the benefits of the treatments or come to agreement on what the clinical endpoints for oncology are. This is where claims data can paint a powerful picture of patient cohorts for trial recruitment.

SDOH Factors & Oncology Trials

In fact, a study in the Journal of Clinical Oncology conducted an investigation of 1,200 cancer care facilities across the U.S. that provides inclusive estimates of clinical trial participation for adults with cancer.

The goal was to provide greater understanding of the factors that influence participation and propose solutions that will increase access and reduce health disparities in oncology clinical trials. However, the rate of trial participation, once shown to be less than 5%, is old data. Therefore, not only tracking participation and recruiting is difficult, but also the lack of historical trial data for oncology studies proves to be challenging to measure benchmarks or what “good” looks like.

Oncology is the top therapeutic area for non-commercially sponsored clinical trials, accounting for up to 25% of all clinical trials, but the number of patients actually participating in these trials is far lower than expected and still low at only 8% of cancer patients participating in a trial.

Due to a variety of underlying issues, many patients are unable to participate in these trials—and this can hinder progress towards new treatments and cures for cancer and other serious diseases.

Health disparities are one of the key reasons why patient access to oncology trials is low – not all patients have equal access to healthcare, which often limits their opportunities to participate in clinical trials.

This includes patients from rural areas or those who lack transportation or financial resources. Additionally, there may be cultural or language barriers that prevent some people from enrolling in oncology trials.

In addition to addressing health disparities, it’s also important that oncology professionals have insights into patient preferences when it comes to participating in clinical trials. These insights can help inform decisions about recruitment strategies and how best to accommodate different patient needs throughout the trial process (e.g., providing transportation services or language support). With this information at hand, oncology professionals can help ensure that more patients are able to take advantage of available clinical trial opportunities.

In our recent State of Diversity & Equity in Clinical Trials report, H1 sourced data from our Trial Landscape platform that showed disparities between breast cancer trials and unique claims for Black patients in that geography in multiple areas of the United States. This challenge proves even greater for international trials where data collection isn’t as robust as in the United States.

The Regulatory Environment

Oncology medical affairs MSLs should be equipped with an up-to-date understanding of current regulations related to accelerated approval as well as any changes that may occur over time in order to ensure compliance with FDA guidelines throughout a product’s lifecycle.

Oncology clinical operations teams should also stay informed about recent advances in technology that could potentially improve efficiencies within their team’s operations (e.g., implementing digital solutions for data collection). Such technology can help streamline processes during feasibility assessments and site management activities while simultaneously helping reduce costs associated with running a trial.

Improving access to oncology clinical trials requires addressing health disparities among participants; gathering insights into patient preferences; staying up-to-date with regulatory requirements; and leveraging technology solutions when possible—all of which are necessary steps in order to ensure higher success rates for accelerated approvals by the FDA for cancer-related medications.

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