Independent clinical trials: a commentary.

The so-called norms of good clinical practice have been incorporated into the Italian regulatory legislation governing clinical trials sponsored by pharmaceutical companies, but there are no legislative provisions governing independent clinical trials: ie those not sponsored by the industry. The pharmaceutical industry has recently increased considerably its commitment to sponsored trials by establishing a series of economic relationships with individual researchers and hospital or university institutions. It has also set up and strengthened a series of bodies and service companies with the aim of making the clinical trials "machine" more efficient. Such developments have aroused alarm in the medical literature because of the risk that they may have negative effects on the freedom of research and research results. At the same time, there is also the risk that independent clinical trials will be greatly penalized by having to compete with sponsored trials in terms of patient enrollment, and because they are currently having to face a series of difficulties connected with the lack or scarcity of economic resources provided by the State or non-profit organizations, with problems relating to patient insurance and to the availability of the necessary drugs. However, the objective of independent trials is to improve the medical art by answering specific diagnostic and therapeutic questions, whereas that of industry-sponsored trials is to generate money, directly or indirectly, by means of the registration of new drugs. It is therefore now necessary to ensure better surveillance of the influence of pharmaceutical companies over the trials they sponsor (as a minimum by ensuring the transparency of a series of potential conflicts of interest between them and clinical researchers) and, simultaneously, protect independent trials from coming to an inglorious end by means of specific support initiatives such as those proposed in this article.