Overall Benefit: Risk Conclusion Clause Samples

Overall Benefit: Risk Conclusion. While there are potential risks associated with the study treatment and the study procedures for this Phase 2 clinical study, the risk is expected to be minimal. The risk to subjects in this study will be minimized by compliance with the eligibility criteria, proper study design, and close monitoring. The risks associated with RIST4721 and co-administration of vaccines for SARS-CoV-2 are not known; therefore, the SARS-CoV-2 vaccine is listed as a restricted medication while a subject is receiving treatment during this study. If a subject requests or requires new or additional vaccination for SARS-CoV-2, the investigator should consider and discuss the potential risks and benefits with the subject. Once a determination has been made the investigator will notify the Medical Monitor. Regardless of their vaccination status, subjects will also be tested at each study visit as part of the routine safety assessments for SARS-CoV-2 to determine if a new infection has taken place. It is expected that subjects treated with RIST4721 might see an improvement in their HS condition and improved quality of life. This study may inform future studies of RIST4721 in HS. All quality, pharmacology, and toxicology data, as well as satisfactory safety and tolerability results, demonstrated in clinical and nonclinical studies are considered sufficient to expect a positive benefit/risk ratio for the treatment of HS with RIST4721, and therefore to initiate this study. Considering the potential benefits, potential risks, and risk mitigation measures that have been implemented in clinical studies with RIST4721, the Sponsor considers the benefit-risk profile of administering RIST4721 for the treatment of HS to be favorable. The overall benefit-risk associated with administration of RIST4721 will be continually reassessed with the emergence of additional data.