PharmExec Blog

Wearable Devices in Clinical Trials: Challenges and Opportunities

Over the years, healthcare professionals have needed to adapt to a more highly informed patient population due to improvements in the availability of accessible healthcare information through the internet. Today, some patients will supplement this knowledge with self-monitoring data, providing an opportunity and a challenge for the treating healthcare professional. The same opportunities and similar challenges arise in the use of wearables in clinical trials, writes Bill Byrom in this Applied Clinical Trials article.

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New "Blockbusters" Will Triple Acute Coronary Syndrome Market

The launch of several drugs with “extraordinary blockbuster potential” will more than triple the acute coronary syndrome (ACS) treatment market, from $12.3 billion in 2013 to $43.4 billion by 2023, according to research and consulting firm GlobalData. Read More »

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Rebranding Risk-Based Monitoring in Clinical R&D

With all of the buzz and excitement around risk-based monitoring (RBM), one might expect that the broad adoption of this emerging clinical research paradigm is well underway. Those familiar with the often painfully slow pace of innovation in the area of clinical R&D, however, will not be surprised by the more sobering reality that only a modest number of clinical trials have adopted a risk-based approach to site monitoring to date. Most organizations engaged in clinical research have been sitting on the edge of the risk-based monitoring pool, anxiously dipping their toes in the water but unwilling to dive in until enough others jump in first and confirm that the water is safe.

Redefining this paradigm may help dispel current misperceptions around RBM and better deliver on the promise of this growing approach, writes Stephen Young in this Applied Clinical Trials article.

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Sanofi Reports Progress Toward First Dengue Vaccine

Sanofi Pasteur, the vaccines division of Sanofi, reports that results of an efficacy study is a step closer to making dengue the next vaccine-preventable disease.

Sanofi points to The Lancet’s published results showing the overall efficacy of the drug maker’s vaccine against symptomatic dengue in 56.5% in children aged 2 to 14 years old after a three-dose vaccination schedule. Results also show an 88·5% reduction of dengue haemorrhagic fever, the severe form of dengue. To date, 27,000 children, adolescents and adults have been vaccinated with three doses of the candidate dengue vaccine throughout the clinical studies.

Dengue is a threat to nearly half the world’s population; it is a particularly pressing health priority in many countries in Asia and Latin America. Each year, an estimated 500,000 people with severe dengue require hospitalization. According to the Sanofi study, one in twenty children in the control group suffered from dengue each year.

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Catching Biopharmaceutical Sponsors by Surprise

The FDA has always been concerned about the safety of patients, and they strongly believe that clinical trials are not sufficient to capture all drug related adverse effects. During an update on The Future of FDA’s Drug Safety Program, Andrew C. von Eschenbach stated, “The full magnitude of some potential risks does not always emerge during the mandatory clinical trials conducted before approval.”

In this Applied Clinical Trials article, Moe Alsumidaie discusses FDA’s post-marketing surveillance programs, and how biopharmaceutical sponsors can work with the FDA to identify unreported Adverse Events (AEs).

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