Conversations: Clinical Trial Data, Transparency and Patient Privacy
Clinical Trials Data: Balancing Transparency and Patient Privacy
08.20.13 | By Karl Uhlendorf
Bringing a medicine to patients, from discovery through FDA review, is a lengthy, costly and sometimes unpredictable process. On average, it takes 10-15 years and an investment of more than $1 billion. As noted previously on the Catalyst, only one out of 5,000-10,000 potential new medicines make it through the multiple and rigorous pre-clinical and clinical trials phases and is ultimately approved by the FDA for patient use. When patients are depending on these advancements to improve or save their lives, the stakes couldn’t be higher.
By all accounts, these trials produce significant amounts of statistical data - both positive and negative - on the safety and efficacy of these potential new medicines, as well as data specific to the patients who are participating in the studies. These data are shared with the FDA, NIH and other regulatory bodies.
PhRMA’s member companies are committed to enhancing public health through responsible reporting and publication of clinical research and safety information, as reflected in new joint Principles for Responsible Clinical Trial Data Sharing recently announced by PhRMA and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
The issue of how best to strike a balance between transparency and patient privacy is critical. It’s a conversation that brings a number of unique perspectives to the table. While viewpoints differ, it’s clear that the common thread is advancing patient health.
For our question this week, we ask the following:
We hope you take a moment to review the current responses and contribute your own thoughts as well via the comments section.