The relationship between doctors and pharmaceutical industries should be regulated by a guarantor: a third figure extraneous to both worlds who becomes an arbiter and supervises the regularity of the execution of clinical studies. This third figure could be a committee made up of representatives of academic institutions. The committee could be called the Collegiate Research Council (CRC). This is the proposal to solve the problem of the relationship between pharmaceutical industries and sponsored clinical studies that starts from the pages of the journal Plos Medicine and is signed by Julio Sotelo, director general of the National Institute of Neurology and Neurosurgery of Mexico. The proposal is well articulated: first of all, the committee should be certified by competent national agencies such as the FDA for the USA or the EMEA for Europe. The role of guarantor of the CRC should be expressed through the evaluation of the clinical study protocol that the pharmaceutical companies must submit to the committee before starting the study. The CRC should have the task of defining the cost of the project, from the remuneration of the researchers involved to the materials used to carry out the research. This evaluation would also serve to establish the real investment of an industry in the development of a new drug and to assess whether the selling prices that are set at the time of marketing are really justified. The CRC should also supervise clinical trials as they are conducted; he could also choose to use experts outside the firm who would have the role of reviewers with respect to the work of colleagues. The results of the studies, even if negative, would be disclosed by the committee. I believe that the proposal of a regulatory body can redeem various biases that make both industries and researchers act in a gray area in which it is difficult to establish when borders are crossed and a conflict of interest ends", writes Sotelo. In the article published in Plos Medicine, the author also illustrates what the benefits could be deriving from the establishment of a judge between the two parties. Meanwhile, the judge, having no personal interests of any kind, guarantees the impartiality and correct conduct of clinical trials; can supervise the acquisition of data and make them public so that there is clarity on the results obtained. As stated in the title of the piece, Sotelo's is a proposal. It is not particularly original: for some time now, in fact, there has been talk of the opportunity to establish a figure that acts as the needle of the balance. After reading the article, a doubt arises that there are already bodies responsible for monitoring the correct conduct of clinical trials in the various stages that characterize them. Is it really a solution to introduce another degree of control? Isn't there a risk of proceeding with Chinese boxes that increase the volume of energy expended but do not change the substance of the problems?
Source: Sotelo J. Regulation of clinical research sponsored by pharmaceutical companies: a proposal. Plos Medicine 2006.
