Clinical trials in Italy: focus on the protocols submitted to Ethics Committees

Abstract

A small portion of research protocols submitted to LECs in Italy relate to innovative research. The new Italian legislation, which decentralizes approval of clinical trials from central to local levels, will lead to shorter approval times and should stimulate more original research. Surveys on LECs activity give important information on active research areas, methodological quality of current studies and outcome of the studies in terms of trial closure and publication of the results. The latter information may be obtained through a follow-up of the cohort of studies included in the present cross-sectional survey.

The Spectrum of Clinical Research with Medications in A Spanish University Hospital. Review of 1.000 Clinical Trials Evaluated by the Research Ethics Committee

“…In addition, the principal objective of these studies is to try to analyze and shorten the approval time and required authorizations to initiate trials, as well as to reach greater uniformity among the various REC resolutions that evaluate a multi- centric CT. Only a few of these articles describe the characteristics of the trials [15][16][17][18][19][20][21][22].…”

“…It is unavoidable to associate clinical trial with pharmaceutical industry, but the rates are different within countries: 63-64% of the trials are sponsored by the pharmaceutical industry in France, 69% in Finland and 84% in Italy [16,21,22]. We can deduce from these figures that countries with investigational tradition have a lower rate of trials sponsored by pharmaceuticals.…”

“…The discrepancy could be due to the fact that 32% of French trials analyzed did not evaluate medications, while in our study that only occurs in 5% of cases. Multicentric CTs are around 87% in Italy [22].…”

“…Although adults and elderly are the population selected in 91,3% of the trials, the figure of 8,7% for children population is important, specially when compared with Italy, where just 4% of the trials have children as study population [22]. The figure is probably supported because of the prestigious of our Children's Hospital, with 25 clinical units, and our booming maternity that turns our hospital into the European hospital with the highest number of labors since 1965 (when it started its activity).…”

A survey on Biostatisticians Serving in the Italian Ethics Committees

“…It has been observed that clinical research can be considered ethical if the following conditions are fulfilled (even if there can be exceptions in particular circumstances): (a) social or scientific value; (b) scientific validity; (c) fair subject selection; (d) favourable risk-benefit ratio; (e) independent review; (f) informed consent; (g) respect for enrolled subjects [17,18]. More generally a trial submitted to an EC must feature, to be approved, a rigorous methodology, clinical relevance and appropriate principles of ethics directed towards patients, society and researchers (19). Notably, some ethical and methodological issues need to be handled with particular relevance by ECs, namely: the appropriateness concerning placebo use for the control group, the nature of the comparator, the equivalence or non-inferiority design hypothesis of the trial and the choice of study endpoints [20].…”