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FDA Recommends Including Patients 12-18 in Adults Clinical Trials

Unfortunately, fibrolamellar falls in the nether world where it does not qualify for funding or regulation for pediatric diseases or adult diseases. Clinical trials for adults start at age 18 and some clinical trials for fibrolamellar have been held up because too many eligible patients were under 18. The FDA has just recommended for the first time that sponsors of clinical trials include patients in the 12-18 age bracket for appropriate diseases. The recommendation was published in Clinical Cancer Research: Enrolling Adolescents in Disease/Target-Appropriate Adult Oncology Clinical Trials of Investigational Agents. Here's the abstract:

"The enrollment of adolescents with cancer in clinical trials is much lower than that of younger pediatric patients. For adolescents with "adult-type" cancers, lack of access to relevant trials is cited as one of the reasons for this discrepancy. Adolescents are generally not eligible for enrollment in adult oncology trials, and initial pediatric trials for many drugs are conducted years later, often after the drug is approved. As a result, accrual of adolescents to these trials may be slow due to off-label use, prospectively collected safety and efficacy data are lacking at the time of initial approval, and, most importantly, these adolescents have delayed access to effective therapies. To facilitate earlier access to investigational and approved drugs for adolescent patients with cancer, and because drug exposure is most often similar in adolescents and adults, we recommend the inclusion of adolescents (ages 12-17) in disease- and target-appropriate adult oncology trials. This approach requires careful monitoring for any differential safety signals, appropriate pharmacokinetic evaluations, and ensuring that ethical requirements are met. Inclusion of adolescents in adult oncology trials will require the cooperation of investigators, cooperative groups, industry, institutional review boards, and regulatory agencies to overcome real and perceived barriers". Clin Cancer Res; 23(1); 1-4. ©2016 AACR

We are pleased to be able to give readers of our website this link to the entire article here, which is not available elsewhere on line.