How to assess assessments?

Combined GADD45A and thymidine phosphorylase expression levels predict response and survival of neoadjuvant-treated gastric cancer patients. E et al. ERCC1 and ERCC2 polymorphisms predict clinical outcomes of oxaliplatin-based chemotherapies in gastric and colorectal cancer: a systemic review and meta-analysis. Niedzwiecki D et al. Postoperative adjuvant chemoradiation for gastric or gastroesophageal junction (GEJ) adenocarcinoma using epirubicin, cisplatin, and infusional (CI) 5-FU (ECF) before and after CI 5-FU and radiotherapy (CRT) compared with bolus 5-FU/LV before and after CRT: Intergroup trial CALGB 80101. A et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. The main principle of regulatory drug evaluation is relatively simple: the marketing authorisation of a medicinal product relies on the demonstrated efficacy, safety and quality of the product. To reach a positive opinion for marketing authorisation, the applicant has to provide evidence that the benefits of the product in question outweigh the risks in the proposed indication. Although the procedures and legal basis may differ across the regulatory agencies such as the US Food and Drug Administration (FDA), Health Canada (HC) and European Union's European Medicines Agency (EMA), all the Western countries follow the principle of 'positive benefit-risk ratio' for drug approval and utilise harmonised Internal Conference of Harmonisation guidelines. From 2001 through 2010, 186 applications for novel therapeutic agents have been reported to have been approved by the EMA, 99 by HC and 225 by the FDA, respectively [1]. Specifically for anti-cancer products, 42 approvals, corresponding to 100 indications, were granted by the EMA between 1995 and 2008 [2]. Along with increasing scientific and financial interests in the field of anti-cancer products, these numbers are expected to rise in the near future— highlighted by the fact that oncology is the therapeutic area with the highest number of scientific advice requests received by the EMA [3]. Considering the impact that marketing authorisations and other regulatory decisions have, not only on the clinical practice but also on the conduct of clinical trials, they are quite infrequently analysed or reviewed in the scientific literature. To be provocative, they may often be criticised, but not that often systematically studied. Several papers have been recently published, but they are mostly descriptive in nature or focus on procedural issues or legal framework. For instance, the review timelines have been quite thoroughly analysed [1, 2, 4], …