Cancer: Does mental health influence a person's outlook?

| March 8, 2019

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New research that now appears in the British Journal of Cancer suggests that a person's history of mental health issues may raise their risk of dying from cancer following diagnosis. Though the cancer mortality rates in the United States have "declined steadily" during the past 20 years, it remains the second leading cause of death, both in the U.S. and globally.

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Pharmaceutical Compliance Monitor

Pharma Compliance Monitor (PCM) is only publication that spotlights regulatory and compliance news and developments for the pharmaceutical and biotechnology communities. PCM’s ongoing goal is to create a place where pharmaceutical and biotechnology professionals and executives can go to stay informed, interact and learn. Read by senior compliance professionals and executives at many of the largest research-based pharmaceutical and biotechonology manufacturers, PCM speaks to the decision maker faced with making mission critical choices that anchor best-in-class corporate compliance and ethics programs.

OTHER ARTICLES

Enabling Active Pharma Ingredients for Batch Balancing and Integration to SAP EWM

Article | April 6, 2020

Batch and its Classification system are two most potent weapons used in Chemical, Pharma or Medical life science industry to record the potency of a batch or technically called as Active Pharma Ingredients(API). These material consist of one or more active ingredients, concentrates, carrier materials, or impurities, and so on. The potency of the active ingredients varies from batch to batch. The active ingredient is the substance of greatest interest in the bill of materials, the proportion of which may vary from batch to batch. Therefore, during creation of a process order, the system must be able to select and adjust the batches needed to obtain the required amount of active ingredient. Take an example of a drug hydroxychloroquine which is used as potent weapon to fight COVID-19. This drug is manufactured by using API, however, the Potency of this API material vary from batch to batch. To map this kind of requirement in SAP ERP, SAP calls it as Material Quantity Calculation.

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Clinical Supply Availability & Speed to Study Start-Up

Article | March 26, 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.

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Do Clinical Trial Delays Mean Trouble for Pharmaceutical Stocks?

Article | April 1, 2020

Pharmaceutical stocks have been somewhat of a safe haven for investors as the coronavirus outbreak spread from China to the rest of the world. But as the pandemic deepened, now resulting in more than 782,000 cases worldwide, even these "safer" companies are beginning to feel the effects. The U.S. is now the coronavirus epicenter, with the most cases -- more than 161,000 as of today. Initial concerns for drugmakers had to do with the supply of active pharmaceutical ingredients, which often come from China. The worry was that pharmaceutical companies wouldn't be able to produce enough of their drugs for patients.

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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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Spotlight

Pharmaceutical Compliance Monitor

Pharma Compliance Monitor (PCM) is only publication that spotlights regulatory and compliance news and developments for the pharmaceutical and biotechnology communities. PCM’s ongoing goal is to create a place where pharmaceutical and biotechnology professionals and executives can go to stay informed, interact and learn. Read by senior compliance professionals and executives at many of the largest research-based pharmaceutical and biotechonology manufacturers, PCM speaks to the decision maker faced with making mission critical choices that anchor best-in-class corporate compliance and ethics programs.

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