Cost of clinical trials worries donors

The more medical successes there are, the more it costs to find the next one, prompting donors to demand more from researchers carrying out large-scale trials of drugs, vaccines and global health impacts.

“As a funder, I hate clinical trial applications,” said Jimmy Whitworth, head of international activities at the science funding division of UK-based Wellcome Trust, which finances health research.

Clinical trial costs have spiralled in recent years - one recent report estimated a 70 percent cost rise per patient between 2008 and 2011 - but without sound evidence of beneficial medicinal effect, regulatory agencies will not approve.

A clinical drug trial can take up to 12 years, enrol thousands of participants across continents, and cost from as much as US$1.3 billion to nearly $12 billion for each new drug before it is approved for public use.

And the costs keep climbing. “We need other ways of funding that are more flexible, quicker,” said Geoff Garnett, deputy director of the HIV Department at the US-based Bill & Melinda Gates Foundation.

“I think a lot of what we should be doing is public health trials rather than clinical trials,” Garnett commented. “If we bog down our public health trials with clinical trial requirements, then we miss out on some of the important behavioural and organizational interventions that make clinical care and prevention work much better.”

Why so costly?

A greater number of participants must be tested in more settings, including those living where reports of a particular disease are falling, to determine whether improvements are the result of the proposed intervention or are being produced by existing ones.

Bloated trials mean more researchers, institutes and funders, which in turn increases regulatory requirements.

“The reality is, trials are getting steadily larger and more expensive… regulation is becoming ever more complicated,” said Chris Witty, research director at the UK Department for International Development (DFID). “We’re paying more and more for less and less.”

Too ambitious

As researchers compete for dwindling research and development dollars, donors criticize overly ambitious proposals.

“The timetables are often extremely optimistic, so there is a real problem in that funding may run out before the research question is actually answered, said the Wellcome Trust’s Whitworth. “Frankly, very often clinical trials don’t look great value for money.”

HIV research has tended to carry out trials in the most expensive way, Witty said, noting that researchers often make poor correlations between cost and the potential impact of a study.

Donors and researchers are looking at partnerships and other ways to bring down costs, including “adaptive testing”, which uses real-time data to modify an ongoing trial.

New funding

In 2010, the Bill & Melinda Gates Foundation pledged $10 billion to research and develop vaccines for some of the world’s poorest countries and its grants database shows more than $70 million going to clinical trials since 2004.

In the UK, the Wellcome Trust, the Medical Research Council (MRC) and DFID have committed $57 million to fund late-stage trials of interventions in cash-strapped countries.

“Give us the evidence,” said Wendy Ewart, deputy chief executive and director of strategy at MRC. “Make the case for future funding.”

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