Diet-Drug-Related Cardiac Valve Disease: Surveillance Methods for Obesity Clinical Research

TONI BRANSFORD | January 23, 2017

article image
Prevalence of obesity has reached and surpassed epidemic proportions, with trends in cardiovascular risk factors such as hypertension, hyperlipidemia, and diabetes, rising in parallel leading to an excess of cardiovascular events.

Spotlight

Progressive Medical, Inc.

We have an innovative way of helping clients control their workers’ compensation pharmacy and ancillary services costs – so they can save money while dramatically improving long-term outcomes for injured workers. From start to finish, we’re working towards our promise - to achieve the lowest total program cost through more control and better outcomes.

OTHER ARTICLES

What to Watch in 2020: Non-Specialty Drugs

Article | March 1, 2020

Pharmaceutical manufacturers are constantly working to develop new and improved medications. Join us as we explore the non-specialty drugs you should be watching in 2020. If you missed last week’s article about the most important upcoming specialty drugs, be sure to check it out here. Approximately 40 new medications are approved by the Food and Drug Administration (FDA) every year.1 (Please note: If you’re curious about what it takes to develop a drug and bring it to market, check out our previous article). Why should you care about these new medications? Because they can affect both your organization’s pharmacy spend and your members’ cost share. For non-specialty drugs, we will focus on medications that may come to market this year, including ones that are currently being reviewed by the FDA, or that are in the last clinical trial (Phase III) stage.

Read More

Clinical Development Risks and Issues in a COVID-19 World

Article | March 1, 2020

Global clinical guidelines have shifted the industry toward risk-based approaches for the planning and execution of clinical trials. The ICH’s guidelines for Good Clinical Practice state that sponsors should evaluate identified risks against existing risk controls by considering “the likelihood of errors occurring, the extent to which such errors would be detectable, and the impact of such errors on human subject protection and reliability of trial results” (ICH E6 R2).

Read More

Five Ways to Manage Your Trial Effectively in a Fast-Changing Global Environment

Article | March 1, 2020

Over the past half-century, clinical trials have grown increasingly complex. A flood of new data from novel sources combined with more elaborate study designs and tougher regulatory standards have lengthened timelines and hiked costs, contributing to a steady decline of efficiency. It all adds up: Nearly half of all drug launches underperform revenue expectations. And if that isn’t enough, the outbreak of COVID-19 worldwide is having an effect on how life sciences companies operate their businesses, including how clinical trials are conducted. Most clinical trial research organizations have tried to adapt by tweaking a platform here, adding a new app there, but this has only yielded patchwork systems of sites, spreadsheets and dashboards that further burden the process.

Read More

Clinical Supply Availability & Speed to Study Start-Up

Article | March 1, 2020

If you’re part of a clinical study team racing a new product to commercialization, you likely live by these two simple rules: time is money, and the first one to market wins. But just because it’s simple doesn’t mean it’s easy. That ticking clock is background noise to the responsibilities of regulations, study protocols, supply chains, and patient recruitment — all the details that must be worked out before a study can even begin. The pressure is always there. The longer it takes for a study to start, the longer it takes to complete.

Read More

Spotlight

Progressive Medical, Inc.

We have an innovative way of helping clients control their workers’ compensation pharmacy and ancillary services costs – so they can save money while dramatically improving long-term outcomes for injured workers. From start to finish, we’re working towards our promise - to achieve the lowest total program cost through more control and better outcomes.

Events