Growing up in a green area may help support mental health

| February 28, 2019

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New research from Aarhus University in Denmark suggests that people who have grown up in close contact with nature are much less likely to develop mental health problems in adulthood than peers who had less access to green space as children. According to recent studies, mental health problems have been on the rise in the United States, with particular increases in cases of anxiety and depression.

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GENTEC Pharmaceutical Group

Gentec pharmaceutical group is a private Spanish company, established in 1985, with headquarters located in Barcelona.

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

Article | March 11, 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.

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Pricing of drugs – at what cost?

Article | February 27, 2020

We go into a doctor’s office and leave with a diagnosis and a prescription. Next we stop by the pharmacy. In Germany, if your insurance is not private, you mostly don’t even know the price of your drug because it’s paid for directly by your insurance. You only notice the 5-10 Euros copay. But how is a drug priced in Germany? And (how) does data play a role in helping pharma secure an attractive price point? Let’s fast forward directly to the launch of a new drug. At the time of launch, the pharmaceutical company has to present patient level evidence of the drug’s added value compared to existing comparative therapies. In the first year, however, the drug’s price can be defined freely by the company.

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As Pandemic Continues, Rafael Pharmaceuticals Enrolls Patients in Phase III Pancreatic Cancer Trial

Article | April 17, 2020

That simple truth about the severity of the disease is one of the reasons that Rafael Pharmaceuticals is slowly continuing with a Phase III trial in metastatic pancreatic cancer during the COVID-19 pandemic. While many companies have paused enrollment in clinical trials during the outbreak, Cranbury, N.J,-based Rafael opted to continue to enroll patients in its Phase III AVENGER 500 study of its lead compound CPI-613 (devimistat) in combination with modified Folfirinox (mFFX) as first-line therapy for the disease. Sanjeev Luther, president and chief executive officer of Rafael Pharmaceuticals, told BioSpace that the company made the decision to continue to enroll the trial, which was 75% filled, due to the short timeline patients with metastatic pancreatic cancer have. After discussing the matter of the trial with the company’s leadership team, Luther said they felt comfortable leaving the decision of whether or not the trial should continue to the conducting institute.

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New Dimensions of Clinical Trial Optimization

Article | April 20, 2021

For much of the past three decades, even as methodologies for clinical trial design have advanced and refined, the idea of the optimized clinical trial has centered on optimal patient samples, target enrollment rates, and generally the most efficient uses of scarce resources in the form of patients. Yet anyone who has had to design and optimize a clinical trial, knows that trial optimization occurs within an ecosystem of choices; a series of choices that stretch from the time it takes to implement a clinical trial and submit clinical data for analysis, to general concerns about the cost and power of a clinical trial. A true clinical trial optimization process would try to unify a number of these choices into a single framework for trial optimization. The complexity of clinical trial optimization comes from the need to align priorities on the one hand, and to understand opportunities on the other. We know that at a very general level, clinical operations specialists benefit from simplicity in clinical trial design, and that commercial teams prefer shorter clinical trials to longer ones. We also know that the statistical design of a clinical trial can influence both simplicity and duration. Yet how many sponsors have their clinical operations and commercial teams, sit with their R&D teams to review various statistically nuanced design options? For many sponsors, the reason this process does not occur as often as it should, is because the nuanced statistical parameters of a clinical trial design are very difficult to communicate to non-statisticians. Yet a trial optimization tool like Solara, equipped with data visualizations and the ability to see tradeoffs intuitively, can overcome this challenge. The real challenge is often convincing the non-statistician that they have a stake in clinical trial design. Cytel recently had a client that thought it needed a sample size re-estimation design, because it had a very strict limit on the number of patients it could enroll. After a few hours of working with Solara, though, a statistician discovered that a much simpler Group Sequential Design would deliver comparable power using about the same number of patients. The gains from the more complex design were minimal from the optimization perspective, when understood as the eco-system of choices. Similarly, most commercial teams pressure their clinical trial designers to have the most accelerated clinical trial imaginable, but as we all know, the longer the clinical trial the more likely there will be a higher number of events that demonstrate the effectiveness of a new medicine. So commercialization teams have a stake in longer clinical trials, even when their rule of thumb is to shorten them. Therefore, it is absolutely essential to communicate the benefits of various statistical designs to multiple stakeholders in a way that makes tradeoffs clear. Aligning on priorities early during the clinical trial design process is essential to selecting the optimal clinical trial. Yet for this statisticians need to be equipped for both a strategic and communicative role in the R&D process.

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