To speed up the drug development process and to create more participant-centered clinical trials, many new methodological and organizational accelerators are adapted. The traditional structure of clinical trials with human participants – 3 phases of trials before medicine’s registration and labeling – evolves. Adaptive methods of trials speed up the process of drug development but make the transparency of the process and results less clear. While lively theoretical discussions are taking place about the ethical challenges of adaptive trials design, there is very little systematic data on this issue.
The risk-benefit ratio, the number of participants required in adaptive and accelerated trials, transparency and the quality of reporting – these factors demand a systematic assessment that will be provided by the meta-research series planned in this project.
The overall goal of the CARTHAGO project is to address the applicability of gene therapy in osteoarthritis and intervertebral disc degeneration from different perspectives, including optimization of cell delivery, gene expression and tissue penetration. The Jagiellonian University part of CARTHAGO aims to deliver an evidence-based analysis, ethics policy, advisory and training for all participants in the project.
Precision medicine concerns a new approach in treating patients by tailoring the appropriate therapy to the individual needs and genetic characteristics of a single patient. To test new potential therapeutics in a more rapid and efficient way, new models of conducting clinical trials have emerged. They are called “basket” and “umbrella” clinical trial designs and the number of such trials is rapidly increasing.
The aim of the project is to perform theoretical and ethical analyses of basket and umbrella studies in the context of seven fundamental requirements of ethical research.
Careful analysis of risk and benefits in novel research models in the era of precision medicine will enable the proposal of recommendations to increase the benefits for participants and society and reduce risks.