Conflict of Interest and Medical Innovation Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary (2014) / Chapter Skim
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3 Perspectives on Conflict of Interest Policies
3 Perspectives on Conflict of Interest Policies
Pages 21-30
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From page 21... ...
• Research needs to drive risk–benefit analyses for collaborations, and legal processes need to be devised to enable partnerships within the framework of conflict of interest policies. • Innovative ways for accessing expertise are needed to provide prompt knowledge and guidance within current policies.
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From page 22... ...
"This is absolutely fundamental to our research enterprise" and to innovation, she said. Various organizations have conflict of interest policies, including the federal government, state government, research institutions, and professional societies.
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From page 23... ...
When the Physician Payments Sunshine Act database appears that same month, it may list payments made to the investigator at $5,100 because she has received $4,500 plus the transfer of value of a plane ticket, hotel, and meals. Without the context, the variation in disclosures could be misleading.
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From page 24... ...
AAMC is starting to analyze the background data and intends to provide data updates as the project proceeds, Pierce said. Early analysis of data from before the rule compliance deadline will look at implementation costs, conflict of interest review processes and infrastructure, and non-financial impacts on institutions and faculty.
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From page 25... ...
In this case, Genzyme supplies the drug at no cost, and the university provides the disease expertise to develop an inhaler-based formulation of GM-CSF and to complete a toxicology study prior to studying its use in clinical trials. The Discovering New Therapeutic Uses for Existing Molecules program, which Rockey mentioned, seeks to repurpose existing compounds 1 National Center for Advancing Translational Sciences.
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From page 26... ...
NCATS is trying to address these issues by collaboratively developing a tissue chip, which is an in vitro platform that uses human tissues instead of whole animals to predict drug efficacy, pharmacokinetics, and safety. The intention is to create a modular, reconfigurable platform to produce physiologically relevant, genetically diverse, and pathologically meaningful results.
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From page 27... ...
These policies should serve science rather than penalize it, Balakrishnan said. SERVING ON ADVISORY COMMITTEES Federal advisory committees provide formal recommendations on policy to federal agencies, said McMurry-Heath.
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From page 28... ...
FDA achieved this by collaborating with scientific and clinical professional societies to create a Network of Experts to provide "rapid access to scientific, engineering, and medical expertise when it is needed to supplement existing knowledge and expertise."2 When a specific scientific question arises, FDA can put out a call to the organizations in the network to find experts who can answer the question. The organizations then provide the names of relevant experts.
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From page 29... ...
Category A is for questions of limited risk. Category B is for questions of moderate risk, such as those involving a specific product line or a medical indication.
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