news roundup
Case studies on apps and wearables, panel discussions on patient first solutions, plus regulatory updates around clinical trial innovation will take center stage this week in Philadelphia.
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Exclusive Video from DIA
Watch Michael Keens and Lisa Gorman from Firma Clinical Research discuss patient support related changes in the industry, common questions from sponsors and CROs, and exciting things that will benefit the drug development community.
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A recent JAMA article questioned the safety and efficacy of drugs benefiting from FDA accelerated approval, using Eli Lilly's decision to halt marketing of its cancer drug, Lartruvo, in April due to data from a post-approval study indicating that the treatment does not prolong lives of advanced-sarcoma patients, as an example. But, to others, the outcome, while disappointing, reflects how more expeditious drug development and approval programs are designed to work.
In advance of our August mid-month update, read the latest moves, awards and milestones from last month.
Articles
This articles delves into research conducted by Antidote Technologies and SCORR Marketing to gain a deeper understanding of patient perceptions of clinical trials and their motivations to participate.
This article delves into the reasons why data standardization for clinical research is important, and how efforts to streamline regulatory submissions for new product approvals have encouraged the development, largely through the ICH, to standardize and harmonize the structure of these submissions as eCommon technical documents (eCTD) are progressing.
Blog Posts
On the pharma R&D side, too often the focus on patients is a transactional one, solely to improve patient recruitment, which has proved ineffective and misguided.
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