US Food and Drug Administration published guidelines for clinical trials of cancer treatment. It set criteria for individuals to be tested. They focused on minimum age consideration in cancer clinical trials of Pediatric patients.
Two centers of FDA, Drug Evaluation and Research, and Biologics Evaluation and Research, worked together. They laid stress on including children and those with severe health conditions in cancer trials. This strategy is though against the usual usage of data quality and ethical considerations.
The agency said in its report of pediatric patients that eligibility criteria slow down patient’s access to the clinical trials. In addition, the results for trials are not able to show the number of patients who will use drugs.
The generalizability of the results can be maximized by broadening cancer trial eligibility. It also allows doctors to understand the therapy’s benefit-risk profile of the patients; who use drugs in clinical trials; which is dangerous for patient’s safety.
FDA said that the guidance refreshes approach to clinical trial eligibility which was stagnant in many cases. The agency noted that researchers are following criteria that have become a tradition; and they use it as a template. However, there is no proper research as a basis for this.
Cancer patients with Brain Metastases
FDA guided to include patients with brain metastases. So that many agents can get serious central nervous system (CNS) toxicities.
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As high-quality medical imaging is now accessible to differentiate toxicity from metastatic progression. So, regular imaging should now be used for the patients with brain metastases.
CNS screening must be used in the study of different types of drugs; such as drugs which can cause bleeding or those which lower the seizure threshold.
The agency provided detailed guidelines to include those patients who have metastases either treated or stable; those with leptomeningeal metastases and those with active brain metastases. They also reviewed the criteria for exclusion.
Patients with Hepatitis or HIV Infection
They guided to include HIV and Hepatitis B virus patients (HBV) as the results for these patients can be used for many other types. The agency also noted that hepatitis C virus infections (HCV) patients are treatable.
Patients with Organ Dysfunction
FDA noted that the general population lives longer and lives with comorbidities and cancers.
The institute believes that excluding the trials for some particular patients may favor younger patients; mostly, patients who have major organ dysfunction or previous or concurrent cancers. Such trial recruitment “may not be fully representative of the population” for which the drug is indicated.
“Designing cancer clinical trials that include patients with organ dysfunction and prior or concurrent malignancies and including this information in the labeling promotes the safe and effective use of these products across a broader patient population likely to use the drug in clinical practice”, the guidelines added.
Guideline asked to include patients who have renal dysfunction; advising that eligibility criterion used glomerular filtration rate instead of absolute serum creatinine levels. They applied criteria through the drug development process.
The criteria included patients who had cardiovascular dysfunction. It depended on the risk of heart failure and prolongation risk of the corrected Q-T interval in the cardiac cycle.
According to the guidance, patients who had malignancies in the past, or have concurrent malignancies are eligible for clinical trials. They can be included whether the tumor is similar or different from that of which is under consideration.