In today’s age of technology, there are an increasing number of options and approaches for research organizations to adopt decentralized models for conducting clinical trials. Due to the recent adoption of remote workflows in the Covid-19 landscape, it is becoming increasingly convenient to participate in clinical research and advance human health. Additionally, with a decentralized model, research organizations have the ability to increase access for historically disadvantaged and under-represented groups, such as minority or rural populations. With benefits like these, we have the opportunity to truly change how research is conducted and for whom.
However, even with numerous benefits, there are unique challenges to a decentralized trial the industry must overcome. Participant protection must continue to be at the forefront of researcher’s minds, as well as upholding data integrity at all times. Outlining the benefits and challenges to a decentralized clinical model, this whitepaper provides sponsors and institutional review boards with a framework to understand ethical issues associated with decentralization. Additionally, it provides tangible steps to include in your design and review of decentralized research elements.
Download Advarra’s whitepaper, “Ethical Issues in the Design and Review of Decentralized Research” to investigate essential considerations and regulations in decentralized modalities.