Increasing Percentages of New Drugs are Failing Phase II and III Trials

In the drug discovery pipeline, Phase I trials are first used to evaluate if a new drug is safe, then Phase II trials are done to assess the drug’s efficacy, and finally Phase III trials are performed to monitor side effects and compare the drug to similar compounds already on the market. Each consecutive phase includes more people to refine the results obtained in the previous phase. A recent analysis by the Centre for Medicines Research in the UK has concluded that since 2008, the failure rate for drugs in Phase II and III clinical trials has been rising [1-2]. Phase II success rates are currently at 18%, lower than at any other phase of drug development.

Drug development pipeline

Avastin, the FDA and Breast Cancer Patient Survival

The impact of the Patient Protection and Affordable Care Act (PPACA) will be front and center later this week when the Food and Drug Administration (FDA) decides whether to revoke marketing clearance of the cancer drug Avastin for breast malignancies.

On one side, you have critics of the FDA accusing them of rationing healthcare while on the other side, you have comparative effectiveness research showing that there’s no statistically meaningful difference in the survival of patients receiving Avastin plus chemotherapy compared to chemotherapy alone.


Top 6 Most Important Cancer Advances of 2007

The American Society of Clinical Oncology (ASCO) recently published its third annual Clinical Cancer Advances report, Clinical Cancer Advances 2007: Major Research Advances in Cancer Treatment, Prevention and Screening [1]. It was developed under the guidance of a 21-person editorial board consisting of leading oncologists and cancer specialists, including specialty editors for each of the disease-specific and issue-specific sections. The report highlights 6 major advances in cancer research in 2007 and describes an additional 18 other findings of significant importance, demonstrating the pace of progress being made in cancer prevention, screening, treatment, epidemiology and survivorship.