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Brazen Scofflaws? Are Pharma Companies Really Completely Ignoring FDAAA?

Placebo Control

If a sponsor gets approval from FDA to delay reporting (as is routine for all drugs that are either not approved for any indication, or being studied for a new indication – i.e., the overwhelming majority of pharma drug trials ), but doesn't post that approval on the registry, the JCO authors deem that trial “noncompliant”.

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How using AI in clinical trials accelerates drug development

Pharmaceutical Technology

Drug development is already a difficult endeavor, with the vast majority of R&D efforts failing to produce a market-worthy product. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S. Food and Drug Administration approval.

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HCP’s use of social media: the good and the not so good

World of DTC Marketing

HCPs don’t necessarily want pharma trying to sell products via social media. The best approach is to use social media to connect HCPs to clincial information and drug trials. A leading pharma company recently sponsored a series of Q&A around the use of their new cancer drug.

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Bayer-led project on AI in trials eyes ‘virtual’ placebo groups

pharmaphorum

The first project between Bayer and Aalto got underway in June 2021, and focused on using technology to make it easier for patients to participate in drug trials. Along with remote monitoring of patients to reduce clinic visits, it is also looking at using AI to improve the safety and efficiency of the clinical drug research.

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Treatment for all: the key steps to better representation in pharma

pharmaphorum

In 2020, 53 novel medicines were approved by the FDA and of the patients who took part in trials, just 8% were black and 6% were Asian. This is not a box-ticking exercise and in some ways it’s as much about cultural intelligence as cultural diversity.