Complex Clinical Trial Protocol Designs: The Effect on Research Sites and the Role Central IRBs Play in Ensuring Quality
About the Webinar Randomized controlled trials have historically been the “norm” for the clinical research industry when looking to demonstrate the efficacy of a new therapy or treatment. As the field grows and looks to become more efficient, make go/no-go decisions quicker, and minimize the time and burden for stakeholders, new study types are being […]
In the post-pandemic clinical research world, there is an opportunity to reverse some of the negative trends.
This year the U.S. Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections (SACHRP) has approved two sets of recommendations in the context of payments in research. The first set of recommendations, which were approved in July 2019, address concerns that arise when sponsors and investigators want to offer payments to […]
The number of drug products under development that incorporate recombinant or synthetic DNA or RNA, viral vectors, and/or genetically-modified organisms (“GMOs”) continues to grow rapidly, and several such products have received marketing approval from the FDA. This paper focuses on important points to consider when planning to initiate clinical trials with these products at sites inside or outside the USA, if the […]
To minimize the financial and administrative burden on patients who are seeking single-patient expanded access (EA) of investigational products, Western Institutional Review Board (WIRB) provides IRB review of expanded access applications at no cost, when there is no local institutional review board to provide this review. WIRB provides this review in accordance with the existing […]
In recent years, along side the increase in patient involvement in the design and conduct of research programs, there has been a notable increase in the idea of “virtual” or “decentralized” clinical trials. In the virtual trial model, clinical studies are focused on bringing the clinical study directly to the participant and allowing data collection to be […]
On January 21, 2019, most federally funded research will need to follow the 2018 Requirements of the Common Rule (“Revised Rule”), while research funded by the Department of Justice will need to follow the Pre-2018 Requirements of the Common Rule (“Original Rule”). Except for Department of Justice Research, research approved before January 21, 2019 can […]
According to breaking news reports, a researcher in China claims to have used CRISPR gene editing to deliberately introduce permanent alterations in germ-line chromosomes of human beings. As yet there is no technical evidence for these claims, and the researcher has reportedly been suspended by his research institution. Based on current evidence, we cannot rule out […]
Approximately 20% of cancer clinical trials will never be completed, because they fail to enroll enough participants to be able to answer the research question. Read this white paper to learn the impact that participant payments may play on clinical trial recruitment.
The purpose of this glossary is to provide clarification of commonly used terms in the discussion of genetics, genetic testing, and precision medicine. The terms are provided alphabetically, with illustrations of several of the key concepts. As genetic testing becomes increasingly common as an integral part of clinical development programs, understanding the key terms and […]