Analysis of registered clinical trials in Italy regarding dermatology (2003-2022): a cross-sectional study on historical trend and prospects for industry investments.

BACKGROUND

This cross-sectional analysis intends to evaluate trend and outlook of industry clinical research in Italy regarding dermatology and its prospects for the next few years.

METHODS

A computerized search of ClinicalTrial.gov database was carried out considering the 20-year period 2003-2022 using the following string: "Skin Diseases OR Skin cancer OR Skin Neoplasms OR Skin Infection OR Skin Lesion OR Skin Ulcer OR Skin Laxity OR Skin toxicity OR Dermatologic Complication OR Skin abnormalities".

RESULTS

During the last 20 years 690 Industry Clinical Trials (IndCTs) were conducted in Italy regarding dermatological investigations, almost entirely funded by non-Italian pharmaceutical companies, involving 4497 centers, and recruiting an average of 13.0 subjects per site. The number of controlled and randomized studies has grown quite regularly and in the last 5 years they represented 79.6% of IndCTs initiated. Countries most frequently sharing with Italy international protocols were Spain (75.0%), Germany (71.8%), France (68.5%), the USA (67.4%), and the UK (54.8%). These data point to a historical involvement of Italy in dermatology IndCTs lower than in the major European countries. However, the war in Ukraine has deprived IndCTs of the contribution of Russia, Ukraine, and Belarus, meaning a mean of about 40 new IndCTs per year in a population of 200 million inhabitants. In contrast, many indicators point to Italy as a country with potential in dermatology wider than used in the past: an efficient health care system accessible to any citizen or resident, 4.6 million dermatological interventions per year, low density of IndCTs concerning dermatology, good production of scientific papers in indexed medical journals, relatively low cost of services and labour and geopolitical stability.

CONCLUSIONS

The European Clinical Trials Information System's (CTIS), mandatory for the EU member states since early 2023 allows common, simplified, and harmonized regulatory procedures over the life cycle of clinical trials in Europe (EMA, 2023) and plays in favor of Italy's greater competitiveness in clinical research.