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Imaging in clinical trials.

Erickson BJ, Buckner JC - Cancer Inform (2007)

View Article: PubMed Central - PubMed

Affiliation: Dept. of Radiology, Mayo Clinic, Rochester, MN, USA. bje@mayo.edu

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Clinical trials are an important part of the drug development process... While everyone wants a ‘silver bullet’ cure, seeing small effects may be beneficial in setting a general direction that may be fruitful... Furthermore, getting a large homogeneous cohort of patients is essential in accurately defining the benefits of therapy... Imaging was identified as one of the components that could play an important role in reducing the cost of clinical trials, which is a major component of drug approval costs... The American College of Radiology has initiated UPICT—the Uniform Protocols for Imaging Clinical Trials with the expressed goal of developing “..widely acceptable consistent imaging protocols and quality control procedures across the multiple sites and modalities needed for case accrual…”... Applying statistical methods to reduce variability in reader assessment of therapies with standardized tools could allow a 60% reduction in the size of the cohort required for assessing some devices... Similar reductions seem feasible for non-device therapies... Electronic image management has the potential to improve the quality of data analysis while reducing the cost... Imaging meta-data includes information such as the device used, the settings used, contrast agents, and possibly any processing of the data... Even if the imaging device is operated properly, the images may not be acceptable... The patients are often ill both due to the disease, and due to effects of therapy... This can result in an inability to hold still for good images... Standardization of imaging acquisition, metadata reporting, electronic data management, and image interpretation/quantification will improve the accuracy of endpoint determination in clinical trials.

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Number of submissions of new molecular entities (NMEs) and biologics license application (BLA) to FDA over the past 10 years. (U.S. Department of Health and Human Services-Food and Drug Administration 2004)
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f1-cin-04-13: Number of submissions of new molecular entities (NMEs) and biologics license application (BLA) to FDA over the past 10 years. (U.S. Department of Health and Human Services-Food and Drug Administration 2004)

Mentions: We are experiencing a time of great growth in knowledge about human disease. However, translation of the knowledge into clinical practice has not kept pace. Clinical trials are an important part of the drug development process. The cost of conducting clinical trials has become greater because: 1) regulations on how the trial must be conducted have become more complex; 2) proposed therapies must be compared against standard therapies; and 3) if the end point is survival—it may take longer to reach that end-point as therapies and non-specific supportive measures become more effective. Moreover, therapies administered prior to or subsequent to the experimental intervention may confound the interpretation of survival as an endpoint. Finding valid alternative outcome measures that can be observed soon after the therapy is given could reduce the cost of drug trials, and make effective therapies available to the public more quickly. Imaging can assess therapeutic efficacy for cancers and may be a part of the solution to reduce costs and improve timeliness of clinical trials. (Fig 1).


Imaging in clinical trials.

Erickson BJ, Buckner JC - Cancer Inform (2007)

Number of submissions of new molecular entities (NMEs) and biologics license application (BLA) to FDA over the past 10 years. (U.S. Department of Health and Human Services-Food and Drug Administration 2004)
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC2666946&req=5

f1-cin-04-13: Number of submissions of new molecular entities (NMEs) and biologics license application (BLA) to FDA over the past 10 years. (U.S. Department of Health and Human Services-Food and Drug Administration 2004)
Mentions: We are experiencing a time of great growth in knowledge about human disease. However, translation of the knowledge into clinical practice has not kept pace. Clinical trials are an important part of the drug development process. The cost of conducting clinical trials has become greater because: 1) regulations on how the trial must be conducted have become more complex; 2) proposed therapies must be compared against standard therapies; and 3) if the end point is survival—it may take longer to reach that end-point as therapies and non-specific supportive measures become more effective. Moreover, therapies administered prior to or subsequent to the experimental intervention may confound the interpretation of survival as an endpoint. Finding valid alternative outcome measures that can be observed soon after the therapy is given could reduce the cost of drug trials, and make effective therapies available to the public more quickly. Imaging can assess therapeutic efficacy for cancers and may be a part of the solution to reduce costs and improve timeliness of clinical trials. (Fig 1).

View Article: PubMed Central - PubMed

Affiliation: Dept. of Radiology, Mayo Clinic, Rochester, MN, USA. bje@mayo.edu

AUTOMATICALLY GENERATED EXCERPT
Please rate it.

Clinical trials are an important part of the drug development process... While everyone wants a ‘silver bullet’ cure, seeing small effects may be beneficial in setting a general direction that may be fruitful... Furthermore, getting a large homogeneous cohort of patients is essential in accurately defining the benefits of therapy... Imaging was identified as one of the components that could play an important role in reducing the cost of clinical trials, which is a major component of drug approval costs... The American College of Radiology has initiated UPICT—the Uniform Protocols for Imaging Clinical Trials with the expressed goal of developing “..widely acceptable consistent imaging protocols and quality control procedures across the multiple sites and modalities needed for case accrual…”... Applying statistical methods to reduce variability in reader assessment of therapies with standardized tools could allow a 60% reduction in the size of the cohort required for assessing some devices... Similar reductions seem feasible for non-device therapies... Electronic image management has the potential to improve the quality of data analysis while reducing the cost... Imaging meta-data includes information such as the device used, the settings used, contrast agents, and possibly any processing of the data... Even if the imaging device is operated properly, the images may not be acceptable... The patients are often ill both due to the disease, and due to effects of therapy... This can result in an inability to hold still for good images... Standardization of imaging acquisition, metadata reporting, electronic data management, and image interpretation/quantification will improve the accuracy of endpoint determination in clinical trials.

No MeSH data available.