One VCU Clinical Research

Posted on July 14, 2020 by komornikea

New FDA guidances provide recommendations regarding eligibility criteria for clinical trials of drugs or biological products regulated by CDER and CBER for the treatment of cancer.

They include the following:

• Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections – This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of drugs or biological products regulated by CDER and CBER for the treatment of cancer. Specifically, this guidance includes recommendations regarding the inclusion of patients with human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) infections. This guidance is intended to assist stakeholders, including sponsors and institutional review boards, responsible for the development and oversight of clinical trials.
  • www.fda.gov/regulatory-information/search-fda-guidance-documents/cancer-clinical-trial-eligibility-criteria-patients-hiv-hepatitis-b-virus-or-hepatitis-c-virus?utm_campaign=CDER%20New%2007%2F13%2F2020&utm_medium=email&utm_source=Eloqua&elqTrackId=e601802fc6a648c38889f2851ce51bf8&elq=5d5ef319fa2144b18f97387fbd73cad7&elqaid=13319&elqat=1&elqCampaignId=11366

• Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies – This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of drugs or biological products regulated by CDER and CBER for the treatment of cancer. Specifically, this guidance includes recommendations regarding the inclusion of patients with organ dysfunction or with prior or concurrent malignancies. This guidance is intended to assist stakeholders, including sponsors and institutional review boards, responsible for the development and oversight of clinical trials. 
  • www.fda.gov/regulatory-information/search-fda-guidance-documents/cancer-clinical-trial-eligibility-criteria-patients-organ-dysfunction-or-prior-or-concurrent?utm_campaign=CDER%20New%2007%2F13%2F2020&utm_medium=email&utm_source=Eloqua&elqTrackId=cb83a9b581334fe7ac1b76d63c9af060&elq=5d5ef319fa2144b18f97387fbd73cad7&elqaid=13319&elqat=1&elqCampaignId=11366

• Cancer Clinical Trial Eligibility Criteria: Brain Metastases – This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of drugs or biological products regulated by CDER and CBER for the treatment of cancer. Specifically, this guidance includes recommendations regarding the inclusion of patients with brain metastases. This guidance is intended to assist stakeholders, including sponsors and institutional review boards, responsible for the development and oversight of clinical trials.
  • https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cancer-clinical-trial-eligibility-criteria-brain-metastases?utm_campaign=CDER%20New%2007%2F13%2F2020&utm_medium=email&utm_source=Eloqua&elqTrackId=e29679d1bef84fcea2fb2e9f6772a6f9&elq=5d5ef319fa2144b18f97387fbd73cad7&elqaid=13319&elqat=1&elqCampaignId=11366

• Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients – This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of drugs or biological products regulated by CDER and CBER for the treatment of cancer. Specifically, this guidance includes recommendations regarding the inclusion of pediatric patients (i.e., children and adolescents) when appropriate. This guidance is intended to assist stakeholders, including sponsors and institutional review boards (IRBs), responsible for the development and oversight of clinical trials.
  • www.fda.gov/regulatory-information/search-fda-guidance-documents/cancer-clinical-trial-eligibility-criteria-minimum-age-considerations-inclusion-pediatric-patients?utm_campaign=CDER%20New%2007%2F13%2F2020&utm_medium=email&utm_source=Eloqua&elqTrackId=843041e3a6cf469eab9243b78d2ff8ac&elq=5d5ef319fa2144b18f97387fbd73cad7&elqaid=13319&elqat=1&elqCampaignId=11366