Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Majority of U.S Adults Would Participate in a Nationwide Precision Medicine Initiative Cohort Study

Majority of U.S Adults Would Participate in a Nationwide Precision Medicine Initiative Cohort Study | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Objectives
A survey of a population-based sample of U.S adults was conducted to measure their attitudes about, and inform the design of the Precision Medicine Initiative’s planned national cohort study.

Methods
An online survey was conducted by GfK between May and June of 2015. The influence of different consent models on willingness to share data was examined by randomizing participants to one of eight consent scenarios.

Results
Of 4,777 people invited to take the survey, 2,706 responded and 2,601 (54% response rate) provided valid responses. Most respondents (79%) supported the proposed study, and 54% said they would definitely or probably participate if asked. Support for and willingness to participate in the study varied little among demographic groups; younger respondents, LGBT respondents, and those with more years of education were significantly more likely to take part if asked. The most important study incentive that the survey asked about was learning about one’s own health information. Willingness to share data and samples under broad, study-by-study, menu and dynamic consent models was similar when a statement about transparency was included in the consent scenarios. Respondents were generally interested in taking part in several governance functions of the cohort study.

Conclusions
A large majority of the U.S. adults who responded to the survey supported a large national cohort study. Levels of support for the study and willingness to participate were both consistent across most demographic groups. The opportunity to learn health information about one’s self from the study appears to be a strong motivation to participate.

Pharma Guy's insight:

Precision medicine’s implications for marketers is clear. Just as precision medicine enables clinicians to understand the complex mechanisms underlying health, disease, or a condition and target treatments, marketers will need to drill down using sophisticated data analysis to understand where their target audience is. For more, read “Precision Medicine: A Back Door to Patient Data for #Pharma Marketers”; http://sco.lt/8GRNQX

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21st Century Cures Act + Off-Label "Free Speech" = More Adverse Events, IMHO

Congress is racing to produce a panacea for all that ails us—including nettlesome barriers to investment in the pharmaceutical and medical-device sector. The 21st Century Cures Act is rapidly moving through the House Energy and Commerce Committee with bipartisan support. It’s viewed by medical professionals as the most revolutionary change to the Food and Drug Administration’s approval process since the National Cancer Act in 1971, in which Congress and President Richard Nixon declared all-out war on that dread disease.


THE MOST IMPORTANT PROPOSAL in the House bill is the required emphasis on “biomarkers” by the FDA when it is determining the efficacy of a drug or therapy. This would encourage the agency to approve a product that works in a small group of patients sharing certain genetic traits. The current process requires medicines to work reliably among a larger, more general clinical-trial population in order to be approved.

Pharma Guy's insight:


IMHO, If FDA is authorized to approve drugs based on SMALL clinical trial data & for limited use matched to a patient's genotype AND if the FDA cannot limit off-label promotion (i.e., it loses the Amarin case; http://sco.lt/90Sefp) then OTHER small trials can be used to support the "off-label" use of the drugs in a larger population. The net result may be more drugs on the market for which safety data is lacking -- data that shows up in larger trials but not small ones.

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