The CTS (Technical-Scientific Committee), in consideration of the progress of the clinical studies approved so far, of the ongoing trials in the international arena and of the current availability of some therapeutic options for patients affected by COVID 19, considers it appropriate to provide specific indications regarding the submission of requests for clinical trials.

Most of the trials examined since March came from academic or non-profit proponents. The will of the scientific community to contribute to the search for possible therapeutic approaches for a disease that was totally devoid of them was a positive fact in itself. The multiplicity and diversity of the classes of medicines proposed also appeared to be a potentially useful approach at the beginning of the epidemic. However, it turned out that in most cases these studies have failed to enrol the number of patients initially expected and in many cases have not even started enrolment. This risk had already been highlighted in May, when the CTS had drawn attention to the need to verify the effective ability to recruit the expected subjects and had tried to promote a few collaborative studies at national and international level and encourage the aggregation of several clinical centres in order to reach the sample size sufficient to answer the clinical question with methodological rigor and in a short time.

Moreover, unlike at the beginning of the pandemic emergency, the exploration of a large number of possible different therapeutic approaches does not appear justified at the moment.

For these reasons, at this stage the CTS considers it necessary to select in a much more stringent manner the clinical trials to be authorised in order to optimise the efforts on a few relevant studies and, above all, to avoid enrolling patients in studies that are unnecessary and/or have little chance of being concluded. The analysis of the international studies published so far has also shown that only studies with high sample numbers have been able to highlight the effect of the medicines under study.

In particular, the CTS also recommends that requests for clinical trials be supported by a feasibility plan on the possibility of enrolment with respect to the epidemic phase, the availability of an adequate management infrastructure (for example, a platform for patient registration and data collection) and the ability to ensure good data quality and good conduct of studies (also with regard to any insurance obligations). The willingness of the proposers to extend participation to other centres showing a concrete interest in the trial will also be considered.

As for the type of study, new requests that may re-propose one or more of the numerous molecules currently being tested can only be taken into consideration if they clearly aim at the solution of questions still unexplored and of clear clinical relevance in order to reduce the risk of duplication or competition between studies.

Without prejudice to the aspects relating to the feasibility referred to above, pilot studies concerning new classes of medicines can only be considered if supported by a solid rationale.