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
In addition to the four draft documents aiming to overhauling cancer trial guidelines, the FDA also published a fifth and final document offering for recommended criteria for the inclusion of adolescent patients in trials designed for adults.
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.
Do you think it’s a good idea for the FDA to draft proposed changes to clinical trials as a part of an ongoing dialogue with medical research patient advocacy groups? Do you think it should make these decisions unilaterally? Share your thoughts with Patient Worthy!
