Association of International Pharmaceutical Manufacturers reported on the full readiness of the Association’s member companies to continue international multicenter clinical trials (IMCT), which have already begun in Russia to date. Suspension or refusal of actual clinical trials are not planned.
However, a number of IMCT organizing companies announced the cancellation of new clinical trials in our country and discontinuing the recruitment of new patients in active clinical trials. This is due to logistical difficulties, which may interfere with the conduct of IMCT in the proper format and in established deadlines. Non-compliance with information processing standards and validation of the obtained results in centralized laboratories within the framework of requirements that are established by the protocol of a specific study, sets at risk patients’ health and the value of the findings.
In the current situation, member companies of the Association do their best for continued uninterrupted supply of investigational drugs, necessary consumables and laboratory kits to continue international clinical trials in the Russian Federation that have already begun.
“International pharmaceutical manufacturers continue planned work with us, despite the extraordinary situation. Modern pharmaceutical companies are not only about drugs, they are involved in clinical research, physician education, medical community support and scientific activities around the world. This is the most complex conglomerate of scientific institutes, chemical laboratories and digital platforms. Already now, difficulties arise, tied to the disruption of supply chains, for example, with clinical studies. To conduct them, it is corny necessary to ensure the movement of biomaterials to authorized laboratories in Europe. Now that we have broken logistics with part of the world, it is difficult to implement these studies”, says Anton Zybin, CEO Director of Lancet, a national supplier of innovative products for the treatment of socially significant diseases.
He also noted that now it is important to focus on providing to Russian patients guaranteed access to the most advanced treatments, so it is necessary to start immediately the development of domestic pharmaceutical industries. And in this matter, representatives of the pharmaceutical business may be partners of the state, integrating into its policy.