Applied Clinical Trials Blog

EU Questions Electromagnetic Radiation Limits

By Peter ODonnell | Published: January 24, 2012

It is fashionable in many healthcare circles to denigrate the European Union for adopting a high-handed and inflexible approach to many of the complex issues that health policy is fated to cover. It is still more fashionable—indeed almost mandatory—to castigate the European Parliament, the EU’s self-styled representative of the people, for adopting an unrealistically cautious attitude to health regulation. January has offered a compelling instance that such prejudices are certainly not always justified. Read More »

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Government Funded Research, Is it That Different?

By Lisa Henderson | Published: January 24, 2012

In December 2011, the President’s Bioethics Commission released its “Moral Science: Protecting Participants in Human Subjects Research.” The report was ordered by President Obama following an October 2010 revelation that the US Public Health Service supported unethical research in Guatemala from 1946 to 1948 that involved intentionally exposing thousands of Guatemalans to sexually transmitted diseases without their consent.

The Bioethics Commission was then tasked to oversee a thorough fact-finding investigation into the specifics of the studies, as well as assure that current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally. Read More »

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Quicker Review for Generics and Biosimilars on the Horizon

By Tim Denman | Published: January 18, 2012

The FDA’s review process for new drugs is slow. That is not news. But if a new agreement between the agency and the industry is approved by Congress things might get a little quicker. Read More »

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Calculating the Cost of R&D: Defending Tufts Research

By Pharmaceutical Executive | Published: January 13, 2012

Estimates of what it takes to deliver a compound to market are more than an academic exercise — such data has an increasingly important on-the-ground impact on industry revenues,  because if you cannot justify your costs how do you expect to prevail on price? Fundamental to the debate on the “productivity lag” in drug R&D is the assertion that the cost to bring a new compound to market is high—and going higher. Critics of the industry are concentrating their (f)ire on this issue, contending that average cost estimates are excessive and tend to distort the increasingly important calculation of “value” for payers and policy-makers in pricing new medicines. The divide even extends to industry itself, as evidenced by GSK CEO Andrew Witty’s recent assertion that a better consensus is needed to measure drug development costs, based on the principles of “frugal science.” Read More »

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Are Black Box Warnings Enough? Should FDA Do More?

By Kayda Norman | Published: January 12, 2012

According to a recent report from Medco Health Solutions (download here http://medco.mediaroom.com/), one in five insured Americans has taken at least one psychotropic medication in the past year. Overall, Americans have increased their intake of psychiatric medications by 22 percent (from 2001 to 2010), with women 45 and older showing the highest use of these drugs. For their part, men aged 20 to 44 increased their use by 43 percent.

Although the increased use of these drugs may seem to indicate an increase in effectiveness, antipsychotics may be more damaging than beneficial. The FDA noted in 2007 that some anti-anxiety medications such as benzodiazepines actually worsened depression. This caused the FDA to issue additional safety labeling information recommending that patients be under strict monitoring for the first few weeks of treatment. 

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Your Help Needed on Survey

By Lisa Henderson | Published: January 11, 2012

This survey https://www.surveymonkey.com/s/96RD6CH will close on Friday, so this is your chance to share your views on Clinical Trial Agreements.

It is widely known that the site agreement negotiations of Clinical Trial Agreements are a delaying factor in clinical trial start-ups. Applied Clinical Trials and Salvius Legal BV are collaborating on a survey https://www.surveymonkey.com/s/96RD6CH to obtain insight in the way CROs and sponsors manage their site agreement negotiations, what the actual delays are and where the true bottlenecks in the process can be found. Read More »

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The Patient Centered Way

By Lisa Henderson | Published: January 10, 2012

Not quite settled into 2012 just yet, but already the radar seems to be tilting toward subject/patient recruitment and retention. Sure, it’s always been on the clinical trials screen, and it comes up as a topic year after year. But indications are this year, it could signal the true bellwether of change that frankly, is needed.

What I could call “traditional” subject recruitment companies—those that have been around a long time—have been telling the industry for years “think of your subject. Think of what they have to go through to be in your trial. Think about the personal touches you can add” is still true. Read More »

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BMJ Wages War on Missing Trial Data

By Philip Ward | Published: January 6, 2012

The editors of the British Medical Journal have certainly started the New Year in a determined and resolute mood. They’ve published a special issue this week about missing data in clinical research, arguing that this problem distorts the scientific record to the extent that clinical decisions cannot be based on the best evidence.

This is not a new stance. For some time now, the BMJ has been at the forefront of the campaign for the more widespread availability of clinical trial results. It’s also campaigned extensively for greater openness, transparency, and integrity in research. Read More »

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Happier New Year? Busier, Anyway

By Peter ODonnell | Published: January 4, 2012

For those who—understandably—have better things to do with their time than study the inner workings of regulatory authorities, it may perhaps be helpful as another year opens to see at least a snapshot of what two of the principal authorities in the world consider as important upcoming business. Read More »

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2012: Hot Topics

By Lisa Henderson | Published: December 19, 2011

There are predictions, resolutions, and lists that fill out end of year reading for every industry. I’m hesitant to go out on a limb and make predictions because the future is fickle, and resolutions only work with a firm direction. Neither of these will work for the clinical trials industry this coming year.

But what I can outline is what we have control over and that is what Applied Clinical Trials is including in our pages and website next year. Hot topics include: clinical trials of drugs and companion diagnostics; patient-centered approaches; social media; hands-on technology; and a return to the basics. Read More »

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