advice on what to expect and how to prepare

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The Guideline for Good Clinical Practice—an international ethical and scientific quality standard covering aspects of clinical trial design, execution, and reporting—has not seen a revision since November 2016. Considering all the changes the drug development field has seen in nearly every corner in the intervening six years, it might be high time for an update.

Many operations struggle to understand and implement such standards. To learn more, Outsourcing-Pharma spoke with Sonia Araujo, head of product management for LifeSphere Clinical at ArisGlobal.

OSP: Could you please share some of the ways in which the drug development industry’s understanding of the balance between advancing treatments and protecting patient safety has evolved over the years?

SA: For pharmaceutical companies, being first-to-market with a new drug carries long-term financial benefits and a greater market share. Hence, any delays in their clinical trials and getting their marketing authorization can wipe out that potential advantage.

For patients, any delay in getting medicines and treatments to market can affect both their economic outlook and their health; perhaps being the difference between life and death for some individuals. As citizens, we’ve all witnessed in the media when clinical trials have gone wrong, or even when a drug on the market has led to significant adverse reactions in the wider population. Technology advances mean we are all more “in the know.” We understand our health data, we expect a certain level of patient care, and we want faster results.

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