La FDA Propone una Mayor Elegibilidad para los Ensayos de Cáncer en los Borradores

According to a publication Biospace, the American Food and Drug Administration has drafted a series of five new documents meant to better structure and organize future participation in cancer clinical trials.

The news comes in the face of former FDA commissioner Scott Gottlieb’s resignation earlier this month. Gottlieb, in his tenure as commissioner, oversaw the approval of more drugs than any other before.

About the Document Drafts

Four of the drafted documents were merely proposal, largely concerned with determining the eligibility criteria for future cancer clinical trials. They also offered provisional guidelines for the participation of particularly at-risk individuals who might participate in such trials.

Specifically, the documents sought to propose a minimum age for pediatric cancer patients, participation guidelines for patients with previous cancers or organ failure, and similar guiding documents for greater inclusion of patients with cancers that have metastasized to the brain, as well as those living with a chronic infection such as HIV, Hepatitis B, or Hepatitis C.

Pediatric Patient Guidelines

The chief concern with determining the minimum age for cancer trial participation is the highly toxic nature of many of the involved drugs.

In their new guidelines, the FDA stipulated that children younger than two years should not ever participate in adult cancer trials (except in rare circumstances) for this reason.

Patients with Chronic Infection

The new guidelines for patients with chronic infection seem rooted in a desire to increase their participation in cancer therapy trials.

The document states that in many cases the participation of chronically infected patients in cancer trials is completely justified, and drafters hope it might help “accelerate the development of effective therapies in cancer patients with these chronic infections.”

Patients with Organ Dysfunction or Pre-existing Cancer

Of particular concern to the FDA was The evaluation of patients’ renal, cardiac, and hepatic (liver) function. These are the bodily functions they deem to be of most concern under aggressive cancer treatment.

Previously, exclusion of individuals with such organ dysfunction (or pre-existing cancer diagnosis) disproportionately favored the recruitment of younger, more physically robust participants.

FDA researchers say that by admitting more of these patients into clinical trials, any resulting data will be more accurately representative of the population as a whole.

Patients with Brain Metastases

About 70,000 US cancer patients have been diagnosed with brain metastases (cancer cells that have spread to the brain from elsewhere in the body). These metastases seem to increase in rate of occurrence in hand with associated malignant cancers like melanoma, or breast or lung cancer.

Despite that, historically patients with brain metastases have been excluded from cancer trials due to concerns of shortened life expectancy, poor body function, and increased vulnerability to toxicity.

Essentially, these patients were deemed to be too at risk to participate. New efforts to secure their inclusion might help determine the best way to treat these highly in-need individuals.

Adolescent Participation in Adult Trials

Además de los cuatro borradores de documentos con el objetivo de revisar las pautas de los ensayos de cáncer, la FDA también publicó una quinta y última oferta de documentos con los criterios recomendados para la inclusión de pacientes adolescentes en los ensayos diseñados para adultos.

Unlike the other publications, the guidelines expressed here are final and binding. The other four documents described above are merely draft guidance, meant to open a correspondence with groups like the American Society of Clinical Oncology and Friends of Cancer Research. Finalization of those policies will hinge on future discussion.

Criteria for teenage participation will include dosing and pharmacokinetic evaluations, safety monitoring, and ethical considerations. The FDA also stipulated that teens should not participate in early trials designed for adults until preliminary pharmacokinetic and toxicity data has been collected. This is to reduce the potential of needlessly exposing a young individual to a treatment that may do more harm than good.

Some believe the establishment of such guidelines is overdue. Now it’s up to other organizations to respond to the FDA’s drafted guidelines as a component of the continued dialogue of care.


¿Cree que es una buena idea que la FDA redacte los cambios propuestos para los ensayos clínicos como parte de un diálogo continuo con grupos de defensa de pacientes de investigación médica? ¿Crees que debería tomar estas decisiones de manera unilateral? ¡Comparta sus anécdotas, ideas y deseos con la comunidad Patient Worthy! Este artículo ha sido traducido al español lo mejor posible dentro de nuestras habilidades. Reconocemos que tal vez no hayamos captado todas las matices y especificidades de su región, por lo que si tiene alguna sugerencia o desea ayudarnos a refinar nuestras traducciones, envíe un correo electrónico a ideas@patientworthy.com.

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