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# FDA Guide to Streamline Cancer Trial Eligibility Efforts
- URL: https://www.fdaweb.com/fda-guide-to-streamline-cancer-trial-eligibility-efforts/
- Published: 2022-08-05T12:00:00.000Z
- Updated: 2026-09-14T17:54:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152451

A collaboration between FDA, the National Cancer Institute, patient advocacy group LUNGevity Foundation, and industry representatives has developed a forthcoming draft guidance that is intended to modernize and streamline eligibility criteria recommendations to allow more patients to easily enroll in lung cancer clinical trials. Efforts are underway to replicate the process for developing guidance documents on eligibility criteria for other cancers too, according to an online *JAMA Oncology* special communication [article](https://jamanetwork.com/journals/jama/fullarticle/10.1001/jamaoncol.2022.1664?utm%5Fcampaign=articlePDF%26utm%5Fmedium=articlePDFlink%26utm%5Fsource=articlePDF%26utm%5Fcontent=jamaoncol.2022.1664&ref=fdaweb.com).

The collaboration group outlined challenges seen in cancer clinical trial accrual. “Difficulties recruiting and retaining representative participants result in prolonged study duration, premature trial closure, heightened costs of clinical research, and delayed advances in the field,” they note. “Many oncology trials close prematurely, and those that do finish are generally extremely costly. Multiple factors contribute to these problems, including complexity of trial protocols, lack of access to trial sites, and stringent eligibility criteria… Over the past several decades, however, the number and specificity of eligibility criteria have increased substantially, further slowing accrual and limiting generalizability of study findings to real-world populations.”

The group’s new guidance focuses on addressing issues with confusing and inconsistent eligibility criteria in clinical trials for advanced-stage non–small cell lung cancer (NSCLC). It includes a prioritized list of 13 recommended terms for inclusion and exclusion criteria in first-line, therapeutic clinical trials for advanced NSCLC that are intended to support a marketing application. For example, the first criterion is “stage and histologic features of disease” and the guidance recommends that Stage IV NSCLC patients be included, but also patients with locally advanced Stage IIIB disease not amenable to curative intent therapy may also be considered for inclusion. “Metastatic disease does not need to be demonstrated pathologically; the site of biopsy could be either the primary tumor or a metastatic site,” it says.

The next criterion is related to biomarkers that are specific to a targeted agent. The group says clinicians supported allowing locally performed testing when available, because such an approach might save time, effort, and money. They also encouraged flexibility regarding the type of biospecimen, such as allowing results from peripheral blood testing (eg, cell-free DNA) to identify oncogenic alterations associated with FDA-approved therapies. However, industry representatives requested the inclusion of more detail about biomarker measurements to ensure adequate rigor of testing oversight.

The *JAMA* article said the group’s efforts provide a “case study” in lung cancer, but also an ideal approach for developing guidance in other cancers. “Clinical trial eligibility harmonization needs to strike a balance between being too specific (and therefore not replicable in another disease space) and overly general (thus not providing clear items that can be populated), nor must it hinder critical discussion among trial investigators and sponsors,” it says. “We fully expect this guidance to serve as a starting point for protocol development and to evolve with experience over time.”