Contract as a Method for Parties’ Interest Reconciliation in Clinical Trials

The contractual relations occurred while the clinical trial (CT) conduction have been investigated in this research. Author has analyzed the legal nature of the clinical trial agreement taking into account the conditions determined by the legislator as essential ones, has reviewed the parties of such agreement as well as the legal risks occurred because of obligations’ fulfillment under the CT agreement. Author took into account the laws and regulations related to the CT area as well as the legislation and civil-law relations occurred in this context. Additionally the opinions of the researchers and industry’s participants’ available in the сore publications and media sources have been analyzed. The experience of the foreign countries (UK, France, Australia, Belgium, USA) was taken into consideration in order to improve the contractual relations in CT. The options to achieve the parties’ balance of interests involved in the CT conduction were revised by author. Additionally author proposed the possibilities how to decrease the legal risks occurred during the CT agreement negotiation for all the parties of such agreement. Based on the foreign countries' experience author suggested to consider the possibility to implement the industry agreement template in order to harmonize the CT conduction in Russia and to increase the investment attractiveness of Russian clinical trials for the foreign and national pharmaceutical companies.