Clinical Trials- Issue 16

European clinical trial applications have been in decline for years, putting the region’s position as a world-class drug developer at risk. It was no surprise that the European Commission’s plan for a revision of European clinical trials regulation was received with widespread consent. We ask industry insiders how a better streamlined approval system could help to revive the sluggish sector. We also investigate how the large volume of paper-based documentation is hampering the efficiency of trials, and how electronic data collection regulated by industry-wide standards could help to speed up study timelines.

Moreover, we ask the experts about strategies for better success rates in recruitment, and find out how the trend to outsource trials to emerging countries has led to increased risk of medical cargo theft and the need to better secure the supply chain for trials.

And, with a number of potentially groundbreaking medicines in the pipeline, we investigate where Roche ‘s priorities lie in marketing Avastin and Lucentis, both of which have been found to treat wet AMD – but with very different price tags. We also look into the study testing the potential of HIV-1 drug Truvada as the first drug to be used in HIV prevention.

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In this issue

Cutting Red Tape
With European clinical trials in decline and a revision of the clinical trials directive underway, Elisabeth Fischer asks industry experts how a more streamlined approval system could help to boost research.
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Push for Paperless
Collating clinical data is a major logistical challenge hampering the efficiency of trials. Susan Howard of GlaxoSmithKline tells Jim Banks about the benefits of introducing industry-wide standards for electronic data collection.
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Finding Volunteers
Almost 80% of clinical trials fail to enrol on time. Elly Earls asks NIH’S Laurie Ryan, Yale ‘s Tesheia Johnson and Patient Recruiters International’s Nora Retana how this worrying trend can be reversed.
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Cure vs Cash
Avastin and Lucentis have been proven to treat wet AMD, but where do Roche’s priorities lie? Elisabeth Fischer investigates whether the cheaper Avastin could challenge the wet AMD drug Lucentis.
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The HIV Prevention Drug?
HIV drug development focuses mainly on treatment rather than prevention but, as Elly Earls finds out, a drug recently submitted for FDA approval could offer a breakthrough in both prevention and treatment.
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Securing the Supply Chain
With companies outsourcing clinical trials to emerging nations, medical cargo theft has become a major concern. Elisabeth Fischer asks Cathy Brown of Napp Pharmaceuticals about strategies that ensure a safe medical supply chain.
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Next issue preview

The number of drug shortages in the US has risen sharply and the FDA has noted a link to manufacturing shutdowns caused by safety and quality concerns. We explore the tightening regulations on generic pharma manufacturing in the US, and also investigate whether the EU’s proposed quality laws for imported APIs could hamper the industry’s ability to produce medicines in adequate quantities.

Novartis and GlaxoSmithKline are partnering with the US Government to create two centres of innovation for the development and manufacturing of vaccines and medication in the event of a biological threat. Focusing on the development of new ingredients and manufacturing processes, we ask the two companies how they will approach the challenge of having to lead the way in America’s biomedical sector in the decades ahead.

We also explore the new markets of outsourced manufacturing which are emerging out of the shadow of the currently dominating giants India and China, and find out how countries like South Korea, Mexico, the Ukraine, Israel and Taiwan are making a name for themselves in the sector.

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