Outsourcing

Clinical Trials in the US Midwest: Looking Back

Outsourcing

11:08, September 11 2017

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As OCT & CTS Midwest gets underway, CTA pays tribute to previous articles written by authors from the US Midwest

This week in Chicago, IL, Arena International’s Outsourcing in Clinical Trials Midwest conference gets underway for its second edition. Following on from 2016, OCT Midwest will shine a spotlight on numerous issues concerning the pharma, biotech and medical device industries.

What’s more, the conference will also be co-located with the inaugural Clinical Trial Supply Midwest conference. The agenda this year features key topics covering best practices for GMP compliance, navigating regulatory hurdles when shipping products abroad, and more. So as you can tell, a wide array of subjects will be up for discussion with both OCT and CTS Midwest promising lots in store!

But before both events get started, CTA will pay tribute to the industry’s Midwest region by looking back at past articles written by key opinion leaders from the area. Here are five previous articles you might have missed... (click the headline to finish reading the story)

Clinical Research as a Health Care Option by Kathy Vandebelt (formerly Eli Lily & Company)

Global health care in the 21st century is increasingly focused on structuring health care systems around value for the patient. That value can be measured by cost effectiveness, knowledge gained from the practice of evidence-based medicine, and other key concepts.

At Lilly, we believe that the results and practice of clinical research can help support value-based health care delivery. Knowing that it will take cooperation across health care systems, the pharmaceutical industry, and academia to develop feasible solutions, we have recently collaborated with representatives from Wilmington Health, PMG Research, Quintiles, Pfizer, and Harvard to investigate the impact of clinical research on health care overall.

Below is a brief summary of what we found...

Why Putting Patients at the Center of Drug Development Really Matters by Dr. Jeffrey Sherman (Horizon Pharma)

The drug development process is at the epicenter of a seismic shift. Gone are the days when pharmaceutical companies would partner solely with scientists and physicians to develop new medicines, with patients only becoming part of the process upon enrolling in a clinical study. Today, the path from development to FDA approval looks vastly different – with the patient’s perspective and voice playing a critical role in regulatory decision making. And while one voice can add significant value, it’s the collective amplification of many voices that has proven to be most effective in accelerating research.

Tackling Drug Non-Compliance: Part I by Bill Jacobson (Takeda)

While the extent of clinical research today is in many ways astounding – clinicaltrials.gov lists 242,358 studies with locations in all 50 states, and 198 countries as of February 2017 – it is informative to step back and look briefly at the origin of the somewhat rigorous processes we all follow today. Probably the earliest description of a rudimentary trial was that conducted by King Nebuchadnezzar of Babylon sometime shortly after 600 BC, wherein he examined the difference in health outcomes between a group of individuals who sustained themselves on a diet of legumes compared to those who consumed only meat and wine.  While not exactly a placebo-controlled double blind randomized study, there was a clear difference between the two groups. This has been described as the initial observation where a medical test guided a decision about public health.

Once you’re finished reading Part One, click here to read the article’s conclusion.

When Might a Combination of Independent External Researchers and Internal Sponsor Experts add value to Data Monitoring Committees? by Jim Stolzenbach (Independent Consultant)

Data monitoring committees (DMCs) for clinical trials have been used for many years and are vital tools for ensuring that patient safety is carefully reviewed in an unbiased manner. Historically, these committees were most often utilized for larger and relatively long-term Phase III trials with mortality or serious morbidity primary endpoints. There is broad consensus that independent DMC review by experts with no bias or conflict of interest with the sponsor company is critical to ensure patient safety during the conduct of these pivotal trials. More recently, despite the increased complexity of adding DMC oversight to trials, there has been an increase in their use. This expansion has primarily occurred into earlier stage trials that may be supportive of a registration. These non-pivotal trials may include adaptive design elements or protocol defined interim analyses allowing flexibility in the data gathering process.

Nonadherence: One of the Practical Issues Impacting Signal Detection in Clinical Trials by Atul Mahableshwarkar (Takeda)

According to a 2015 report from the Tufts Center for the Study of Drug Development, the success rates of molecules entering clinical development has dropped to a remarkably low rate of 11.8 percent. This ranges from an encouraging 23.9 percent for anti-infectives to the abysmal 4.7 percent for drugs affecting the central nervous system (CNS). There are a number of reasons why CNS drug development brings up the rear when success rates in drug development are assessed...

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