FDA regulations and ICH guidelines both require that "the information that is given to the s... more FDA regulations and ICH guidelines both require that "the information that is given to the subject or the representative shall be in language understandable to the subject or the representative." 1,2 Obviously, if an Informed Consent Form (ICF) is written in a language that the subject does not understand, it must be translated into a language the subject does understand. ICFs are highly technical documents, so careful translation by certified medical translators is essential. Translation errors can change the meaning of important content, causing potential subjects to receive inaccurate information. They can also confuse meaning, so the ICF is more difficult to understand. Many professional translation companies and independent translators are well-qualified to translate ICFs. However, even with certified medical translators, errors can occur because: • Translation is more of an art than a science. • Translators are unlikely to specialize in the specific medical condition...
The "age of majority" is the age at which people automatically obtain freedom from pare... more The "age of majority" is the age at which people automatically obtain freedom from parental control and responsibility, i.e., become "legally emancipated." At that time, they gain the legal rights and obligations of an adult, especially the right to sign contracts and the obligation to be bound by those contracts. In a few states, the age of majority may occur at different ages for different rights and obligations. Unless otherwise specified by state law, a person becomes an adult and is able to give informed consent at the age of majority. In some states, a minor may become legally emancipated before the age of majority. In general, emancipation is complete, but in some cases, early emancipation may be limited to certain purposes, e.g., the right to own property or make decisions about a pregnancy. In some states, for some or all purposes, early emancipation may occur automatically upon marriage or entry into military service. A court may also emancipate a minor...
Manufacturing and distributing clinical supplies can account for 20% or more of the cost of a cli... more Manufacturing and distributing clinical supplies can account for 20% or more of the cost of a clinical trial. 1 A single pill of no obvious distinction can cost hundreds of dollars. In an era when every dollar is important, an efficient supply management plan is thus essential. The cost of clinical supplies is not just the manufacturing cost of the medications. It also includes supply chain planning, management, procurement, packaging, shipping and destruction costs. One Size Does Not Fit All Every clinical trial is different. The optimal supply management plan strikes a balance between seven key factors to deliver clinical supplies when and where needed at minimum cost: Therapeutic Area Trends address questions like disease prevalence; enrollment, adherence, retention, mortality and replacement rates; and the appeal of the study to investigators and subjects in relation to standard of care and competing trials. These issues influence initial, resupply and replacement stocking. ...
The frequency of reported use of a Data & Safety Monitoring Board (DSMB) in industry- sponsored c... more The frequency of reported use of a Data & Safety Monitoring Board (DSMB) in industry- sponsored clinical trials and characteristics of trials involving a DSMB were investigated. Protocols and clinical trial agreements (CTAs) for 32 industry-sponsored trials (21 drug and 11 device) were reviewed. Based on the protocol review, 19 trials (59%) used a DSMB, while none of the reviewed
FDA regulations and ICH guidelines both require that "the information that is given to the s... more FDA regulations and ICH guidelines both require that "the information that is given to the subject or the representative shall be in language understandable to the subject or the representative." 1,2 Obviously, if an Informed Consent Form (ICF) is written in a language that the subject does not understand, it must be translated into a language the subject does understand. ICFs are highly technical documents, so careful translation by certified medical translators is essential. Translation errors can change the meaning of important content, causing potential subjects to receive inaccurate information. They can also confuse meaning, so the ICF is more difficult to understand. Many professional translation companies and independent translators are well-qualified to translate ICFs. However, even with certified medical translators, errors can occur because: • Translation is more of an art than a science. • Translators are unlikely to specialize in the specific medical condition...
The "age of majority" is the age at which people automatically obtain freedom from pare... more The "age of majority" is the age at which people automatically obtain freedom from parental control and responsibility, i.e., become "legally emancipated." At that time, they gain the legal rights and obligations of an adult, especially the right to sign contracts and the obligation to be bound by those contracts. In a few states, the age of majority may occur at different ages for different rights and obligations. Unless otherwise specified by state law, a person becomes an adult and is able to give informed consent at the age of majority. In some states, a minor may become legally emancipated before the age of majority. In general, emancipation is complete, but in some cases, early emancipation may be limited to certain purposes, e.g., the right to own property or make decisions about a pregnancy. In some states, for some or all purposes, early emancipation may occur automatically upon marriage or entry into military service. A court may also emancipate a minor...
Manufacturing and distributing clinical supplies can account for 20% or more of the cost of a cli... more Manufacturing and distributing clinical supplies can account for 20% or more of the cost of a clinical trial. 1 A single pill of no obvious distinction can cost hundreds of dollars. In an era when every dollar is important, an efficient supply management plan is thus essential. The cost of clinical supplies is not just the manufacturing cost of the medications. It also includes supply chain planning, management, procurement, packaging, shipping and destruction costs. One Size Does Not Fit All Every clinical trial is different. The optimal supply management plan strikes a balance between seven key factors to deliver clinical supplies when and where needed at minimum cost: Therapeutic Area Trends address questions like disease prevalence; enrollment, adherence, retention, mortality and replacement rates; and the appeal of the study to investigators and subjects in relation to standard of care and competing trials. These issues influence initial, resupply and replacement stocking. ...
The frequency of reported use of a Data & Safety Monitoring Board (DSMB) in industry- sponsored c... more The frequency of reported use of a Data & Safety Monitoring Board (DSMB) in industry- sponsored clinical trials and characteristics of trials involving a DSMB were investigated. Protocols and clinical trial agreements (CTAs) for 32 industry-sponsored trials (21 drug and 11 device) were reviewed. Based on the protocol review, 19 trials (59%) used a DSMB, while none of the reviewed
Uploads
Papers by Norman Goldfarb