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Clinical trials have become increasing costly ventures, adding to the overall cost of developing a drug and, ultimately, the price that patients pay for drugs. A 2016 estimate by the Tufts Center for the Study of Drug Development, for example, pegged average clinical trial costs across all three phases of development at roughly $340 million in out-of-pocket expenses. Big pharmas and small biotechs alike are looking for innovative ways to improve trial outcomes and, in turn, lower trial costs — this means increasing the efficiency in which they recruit patients, monitoring more closely how drugs are supplied and being more flexible about trial design. Here’s a look at some of the tools that are optimizing clinical trials today:

• Patient centricity
• Tapping into technology
• Data you can wear
• Flexibility
• Automated site supplies

Ned Milenkovich, PharmD, JD, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Wearable tech is increasingly making its way into pharma, and Takeda is welcoming the trend with open arms. Most recently, the Japanese drugmaker partnered with digital health tools venture Cognition Kit to collect active and passive patient data for a deep dive on depression...Each person in the just-launched pilot study will wear an Apple Watch that will passively collect physical activity data all day, while three separate prompts throughout the day will remind the patients to complete cognitive and mood assessments...Results from the study, which are expected in the first half of the year, will look at the wearable mood and cognition measurements, along with compliance, and compare the findings to more traditional examinations and patient-reported assessments... This collaboration is part of our strategy to embrace new technology to better understand the patient experience and assist healthcare professionals in creating improved patient care pathways...

Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

National Football League teams violated federal laws governing prescription drugs, disregarded guidance from the Drug Enforcement Administration on how to store, track, transport and distribute controlled substances, and plied their players with powerful painkillers and anti-inflammatories each season, according to sealed court documents contained in a federal lawsuit filed by former players...testimony and documents by team and league medical personnel, describes multiple instances in which team and league officials were made aware of abuses, record-keeping problems and even violations of federal law and were either slow in responding or failed to comply...

• Disregarding federal laws
• Reliance on pharmaceuticals
• Lining up for the ‘T Train’

For people living in rural areas of the U.S., access to health care providers can be a serious challenge. Pharmacists can be part of the solution. And in a welcome show of bipartisanship, Republicans and Democrats in Congress are co-sponsoring legislation that can help...The Pharmacy and Medically Underserved Areas Enhancement Act...would include pharmacists on the list of recognized health care providers that can be reimbursed by Medicare for providing much needed patient care in underserved areas. USP supports this legislation as a major step forward in improving health care. Here are three reasons why:

• Pharmacists are highly trained health care professionals
• Pharmacists are easily accessible to patients
• Pharmacists improve health care

That pharmaceutical companies charge much more for their drugs in the United States than they do in other Western countries has contributed to public and political distrust of their pricing practices. When these higher US prices...are challenged, the pharmaceutical industry often explains that the higher prices they charge in the US provide them with the funds they need to conduct their high-risk research...This claim—that premiums earned from charging US patients and taxpayers more for medications than other Western countries funds companies’ research—is empirically testable...We found...charging substantially higher prices...in the US compared to other Western countries generates substantially more than the companies spend globally on their research and development...Importantly, our analysis cannot inform the question whether or not it is appropriate for US patients, taxpayers, and businesses to bear the burden of funding pharmaceutical research for the world...

Caterpillar’s lowered drug bills show why pharmacy benefit managers are under fire. A decade ago, Caterpillar Inc. looked at its employee drug plan and sensed that money was evaporating... By hiring its own doctors and pharmacists, among other changes, Caterpillar has saved tens of millions of dollars a year...The model is as successful today as it’s ever been...Caterpillar’s move away from benefit managers started when it suspected that as much as a quarter of its $150 million drug spending was wasted. The company devised its own list of drugs to offer its U.S. health-plan members and negotiated deals with pharmacies. It promoted generics and discouraged use of expensive heartburn and cholesterol medicines. The changes have saved the company $5 million to $10 million per year on cholesterol-lowering statins alone...Drug spending at Caterpillar...has dropped per patient and per prescription since the company started the program...

India’s largest drugmakers are making a case that the U.S. should import cheap Indian-made drugs to hold down healthcare costs, and partner with its pharma leaders to develop inexpensive biosimilars. But Indian pharma companies have a less-than-stellar track record with the FDA on manufacturing quality, and that is casting a cloud over the country’s efforts to partner with President Donald Trump as he pushes to lower drug prices...The Indian Pharmaceutical Alliance made its viewpoints on drug importation clear in a report released recently...The organization...suggested the U.S. would save more by importing inexpensive drugs than it would by boosting domestic manufacturing in an effort to create jobs.