Clinical Protocol Complexity: Negative Impact and Opportunities to Improve Study Success
During the past several decades, the scope and administration burden of industry-funded clinical trial protocols has increased dramatically. This talk reviews more than a decade of scholarly study conducted by a research team at Tufts University School of Medicine. Trends in the scientific and operating complexity of protocol designs will be discussed. The impact of protocol complexity on clinical trial durations and patient recruitment and retention effectiveness will also be presented. The talk will culminate with a discussion of new opportunities to optimize study design and improve study feasibility and success.
As the world becomes more accessible through technology and networking, international research activities are increasing in the academic arena. This program will provide specific information for faculty and students who are planning to conduct international research now or in the future. It is highly recommended that all faculty mentors who will be advising students going abroad attend this session. Ms. Colecchia will discuss administrative, legal and financial policies when conducting research in a foreign location. Ms. LeMenager will provide an overview of IRB considerations which include federal regulations, local ethics review, familiarity with the local culture and norms, in-country collaborators, and a meaningful consent process.
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