The yield of colonoscopy in average-risk patients with non-specific colonic symptoms.

OBJECTIVES: The need for full colonoscopies in average-risk patients with non-specific colonic symptoms is controversial. We aimed to evaluate: (1) the yield of full colonoscopy; (2) the prevalence of proximal neoplasia in these patients; (3) the yield if any of doing full colonoscopies to diagnose proximal lesions in patients in whom the distal colon was clear; (4) the significance of this yield with respect to age. DESIGN: This is a retrospective analysis to assess the value of open access colonoscopy. PATIENTS AND METHODS: All patients who underwent a colonoscopy in our Endoscopy Unit during January 1996 to December 1999 were assessed (n = 3357). RESULTS: We analysed 945 patients with average risk and non-specific colonic symptoms (significant risk factors excluded). The overall yield of adenomas was 5.8%. The yield of distal adenomas in patients > or= 50 years of age was 8.2% (37 out of 450) versus 0.2% in the 50 years group (one out of 495; = 0.0001). The proximal adenoma yield in > or= 50 year olds was 3.8% (17 out of 495) versus 0.2% in < 50 year olds (one out of 495) (P = 0.0001). CONCLUSIONS: In a cohort of average-risk patients with non-specific colonic symptoms attending an "open access" colonoscopy clinic, the yield for proximal adenomas is small in the < 50 years group. In patients aged < 50 years, distal colonic examination is all that is required, whereas a full colonoscopy may be justified in patients > or = 50 years old.

Challenges with advanced therapy medicinal products and how to meet them.

Advanced therapy medicinal products (ATMPs), which include gene therapy medicinal products, somatic cell therapy medicinal products and tissue-engineered products, are at the cutting edge of innovation and offer a major hope for various diseases for which there are limited or no therapeutic options. They have therefore been subject to considerable interest and debate. Following the European regulation on ATMPs, a consolidated regulatory framework for these innovative medicines has recently been established. Central to this framework is the Committee for Advanced Therapies (CAT) at the European Medicines Agency (EMA), comprising a multidisciplinary scientific expert committee, representing all EU member states and European Free Trade Association countries, as well as patient and medical associations. In this article, the CAT discusses some of the typical issues raised by developers of ATMPs, and highlights the opportunities for such companies and research groups to approach the EMA and the CAT as a regulatory advisor during development.