Reducing the costs of phase III cardiovascular clinical trials

Eisenstein, Eric L.; Lemons, Philip W.; Tardiff, Barbara E.; Jolly, M. King; Califf, Robert M.

doi:10.1016/j.ahj.2004.04.049

Cited by 116 publications

(90 citation statements)

References 16 publications

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“…For example, the cost of RCTs can be reduced substantially, allowing very large sample sizes and better representativeness of the enrolled populations, if simple, pragmatic megatrials are adopted and RCD are used for collecting outcome information. 11,12 Nevertheless, such megatrials are uncommon, and thus observational RCD studies are used to fill the evidence gap. For uncommon conditions, even megatrials would have few patients to inform on outcomes in these subgroups.…”

Section: Studies Of Rcd or Better Rcts?mentioning

confidence: 99%

Routinely collected data and comparative effectiveness evidence: promises and limitations

Hemkens

Contopoulos‐Ioannidis

Ioannidis

2016

CMAJ

138

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Section: Studies Of Rcd or Better Rcts?mentioning

confidence: 99%

Routinely collected data and comparative effectiveness evidence: promises and limitations

Hemkens

Contopoulos‐Ioannidis

Ioannidis

2016

CMAJ

138

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“…This could be possible if there were concomitant changes in other regulatory requirements involved in clinical testing, such as the need for extensive site monitoring. 15 Another option would be to increase the period of patent protection to allow companies to generate revenue over a longer period of time to recoup the additional costs from preapproval clinical testing. The government could also subsidize the fixed costs of the clinical research infrastructure, as proposed in the National Institutes of Health (NIH) Roadmap Initiative.…”

Section: R U G -S a F E T Y R E G U L A T I O N S H E A Lt H A F F mentioning

confidence: 99%

How Changes In Drug-Safety Regulations Affect The Way Drug And Biotech Companies Invest In Innovation

Reed

Califf²

2006

Health Affairs

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Changes in the economics of product development resulting from heightened safety regulations could have a sizable negative impact on drug and biotechnology companies' decisions about investing in innovation. We developed a model to compare the potential economic effects of pre-and postmarketing strategies to identify safety problems with new drugs. Although expanding Phase III clinical testing and postmarketing safety surveillance are not perfect substitutes, our findings suggest that even a large increase in funding for the latter will have a relatively small adverse impact on investment decisions by drug companies and venture capital firms, compared with the former. [Health Affairs 25,no. 5

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“…13 To assign costs for clinical testing, we used an estimate of $10,000 per patient, based on a recent analysis of preapproval clinical trials. 14 For the sake of simplicity, we did not discount clinical trial costs, because these costs are incurred within a relatively short time period. Also, because only a small proportion of investigational drugs would have a serious adverse effect corresponding to the assumptions used in our analyses (we assumed 4 percent), we w 3 6 2 5 A u g u s t 2 0 0 8 multiplied clinical trial costs by a factor of 25 to represent the number of safety databases that might need to be generated for different drugs to identify a single drug with a serious safety issue.…”

mentioning

confidence: 99%

Use Of Larger Versus Smaller Drug-Safety Databases Before Regulatory Approval: The Trade-Offs

et al. 2008

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Although efforts to revamp the drug-safety system have been directed at strengthening postmarketing surveillance, strategies for the preapproval stage may be useful. One strategy would be to require larger sample sizes in preapproval safety databases. To evaluate the potential benefits and costs of this approach, we developed a hypothetical model to estimate the expected incremental number of adverse drug events that could be avoided in a postapproval population. We found that the potential to limit adverse events can be an important consideration in sample-size determinations for preapproval trials. Requiring larger preapproval databases could be a cost-effective means of reducing adverse events in postapproval populations. M o s t i n d u s t ry-s p o n s o r e d c l i n i c a l t r i a l s of new drugs are powered to detect differences on the primary efficacy endpoint that will drive regulatory approval. Detection of adverse drug events (ADEs) is rarely considered when sample-size calculations are undertaken for clinical trials. Thus, the statistical power to detect ADEs is inherently a by-product of considerations of efficacy. w 3 6 0 5 A u g u s t 2 0 0 8 D r u g S a f e t y

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Reducing the costs of phase III cardiovascular clinical trials

Cited by 116 publications

References 16 publications

Routinely collected data and comparative effectiveness evidence: promises and limitations

Routinely collected data and comparative effectiveness evidence: promises and limitations

How Changes In Drug-Safety Regulations Affect The Way Drug And Biotech Companies Invest In Innovation

Use Of Larger Versus Smaller Drug-Safety Databases Before Regulatory Approval: The Trade-Offs

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