A Comaprative Analysis of New Drugs and Clinical Trials Rules and Its Impact on Approval Process of Oncology Drugs in USA, CANADA, AUSTRALIA, EUROPE and INDIA

K. Sunil Kumar*¹, Panthagiri Thulasi^2
1Associate Professor, Department of Pharmaceutics and DRA, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India
²Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India

A b s t r a c t
The FDA approves drugs through the clinical trials process. Every clinical trial has a sponsor to fund the research process. Sponsors are usually pharmaceutical companies, government agencies, or healthcare organizations. After gathering data from animal research to determine if a potential drug is effective and safe for human testing, the sponsor of the clinical trial submits an Investigational New Drug (IND) application to the FDA. The IND application includes detailed information on the drug and explains how the trials will be conducted. The FDA regularly provides updates on approved drugs on the FDA website. Even after the FDA approves a drug, the sponsor is still required to report safety updates to the FDA as needed. If new side effects are discovered, the drug’s labeling is changed and the public is informed. If a new side effect is deemed too dangerous, the FDA revokes approval. The US Food and Drug Administration (FDA) approves cancer drugs based on (1) overall survival or patient reported outcomes, (2) progression-free survival, ie, the time until cancer recurs or worsens, or (3) response rate (RR), ie, the percent of patients experiencing tumor shrinkage. The Response rate and complete response rate are typically ascertained in uncontrolled, nonrandomized studies. Because these trials have no comparator arm, drug-related adverse events may be missed among symptomatic patients because they may be mistakenly attributed to their underlying cancer. There is also uncertainty about whether and to what degree these drugs improve survival or quality of life.
Keywords: FDA, Investigational New Drug, Labeling, uncontrolled, nonrandomized studies, cancer and healthcare organizations.