Independent clinical research. The implementation of comparative clinical trials between drugs, aimed at demonstrating the added therapeutic value, as well as on orphan and life-saving drugs, also through tenders addressed to the IRCCS, universities and regions" is one of Aifa's institutional tasks. The word to Silvio Garattini, President of the Research Commission of the Agency
Clinical research represents the main tool for evaluating the efficacy and safety of a drug treatment in the patient. At present, more than 80% of clinical studies are conducted thanks to the more or less direct involvement of the pharmaceutical industry. According to various exponents of the research world, the lack of independent clinical research has a negative impact on the diffusion of knowledge of the benefits and risks associated with the use of drugs. In order to try to increase the number of independent clinical trials in Italy, AIFA has been developing an initiative since 2005 aimed at financing independent clinical research in three areas: efficacy of orphan drugs, direct comparison between drugs with the same indications, outcome studies and pharmacovigilance of treatment. This is an important initiative in the field of clinical research, which has received considerable interest and appreciation, and which fully falls within AIFA's commitments and strategic objectives. We asked Prof. Silvio Garattini, President of the AIFA Research Commission and Director of the "Mario Negri" Institute of Pharmacological Research in Milan, to illustrate the critical issues related to the lack of independent clinical research in the decision-making process of the regulatory authorities and to present the AIFA initiative, now in its second edition and close to the third. What are the main limitations of sponsored search used for drug registration? The limits are represented by the fact that all the dossier presented for the approval of a new drug is prepared and compiled by the pharmaceutical industry, which wants to commercialize its product. Clearly we are faced with a con? itt of interest. However, I don't want to deny the right of the pharmaceutical industry to present the clinical studies produced within it in the applications for registration, but I find it anomalous that this is the only material available to the regulatory authorities to decide on the marketing of a drug and its reimbursement. It is natural that those who have an interest in having a product approved, even unconsciously, tend to at least value everything that can be positive. We therefore need to be able to introduce a balance based on data from other sources, in order to introduce a little more objectivity. What is being suggested by many is that studies conducted outside the pharmaceutical industries be introduced in the registration dossier and, in particular, at least one phase III study be conducted by independent bodies. Another limitation of registration studies lies in the fact that European legislation requires that quality, efficacy and safety be demonstrated in the dossier and does not impose the need to make comparisons to establish what the added value of the new drug is. Quality, efficacy and safety are often demonstrated with comparisons made with placebo, even if there are drugs that are already used for the same indications. Forward
