Current issues in clinical trials of radiopharmaceutical drugs (RPCD) at the present stage of nuclear medicine development

Abstract

To date, doctors are becoming increasingly interested in radiopharmaceutical drugs (RPCD) associated with an improvement in their effectiveness and safety due to the use of alpha-emitting isotopes and highly selective ligands in the formulation. According to MarketsandMarkets, the nuclear medicine market will grow from $4.8 billion in 2021 to $7.5 billion by 2026 at a compound annual growth rate of 9%. The Russian Federation will have to work on import substitution with the analogue development of foreign-made drugs not registered in Russia, as well as original development that must meet world standards. Promotion of new drugs to patients is impossible without conducting clinical trials that meet GCP criteria. Even in countries with a high development of biomedical technologies, there are not enough resources to conduct clinical trials of new RPCDs. The most important limiting factors are the high cost of studies using open sources of radiation and the discrepancy between the traditional method of clinical trials, the unique properties of new RPCD and the effective method of theranostics using diagnostic and therapeutic pairs of radionuclides. To overcome these difficulties in evaluating RPCD, in particular, a phase zero clinical trial on several volunteers with the disease and the establishment of specialized testing clinical centers are proposed.