Observational studies will help answer growing safety demands
pharmafile | September 8, 2009 | News story | Research and Development |Â Â ICON, drug safetyÂ
The pharmaceutical industry is ready to adapt to growing drug safety requirements, but understanding of how it can capture safety data is lagging in some quarters.
Contract research organisation ICON commissioned IMS Health to carry out a survey earlier this year of senior industry executives involved in pharmacovigilance or drug safety.
The survey showed a general consensus that safety had taken on a much greater importance, and that this was due to high profile product withdrawals in recent years.
Among some interesting patterns observed in the responses was that executives in larger companies seem to have felt the impact of new safety pressures more than those in medium-sized companies.
ICON says the growing demand for 'real world' data gathered outside the controlled confines of the clinical trial means patient registries and observational databases will have to be used much more in the future.
But Dr John Hubbard, global president of ICON Clinical Research, says a relatively low level of understanding of registeries was one of the surprising results from the survey.
"While there was an understanding of registries, there wasn't an understanding of their potential around proving drug safety data. We think there is a lot of scope for expanding their role and providing regulators with the data they want."
ICON says patient registries can be used not only for post-marketing surveillance, but also for gathering data before approval, something not widely understood in the industry.
Hubbard adds: "Secondly, the clinical folks didn't believe their commercial colleagues fully understood the implications of this need for greater safety data."
Only 45% of respondents felt their colleagues in sales and marketing had a comparable level of understanding of these safety issues as they did themselves.
Looking at the broader picture, Hubbard predicted that greater collaboration between sponsors and CROs, plus a convergance in standards demanded by national regulators, will help improve R&D productivity.
He says that the 'competing vectors' or pressures on R&D teams means getting the right balance was a great challenge.
US healthcare reform
Any discussion of drug regulation and healthcare inevitably leads onto the subject of US healthcare reform, which is today not just the preserve of people involved in medicine and the pharma industry, but is currently preoccupying all Americans.
Dr Hubbard says there is a great willingness for change in the healthcare system among Americans, but opinion is divided on how best to move forward. He says many are fearful that any changes will not be comprehensive enough, and not address systemic problems.
"Nobody has tackled this in a consistent way. It is a more piecemeal approach being taken. Let's look at this end to end and figure out where the drivers of cost are.
He says: "Healthcare costs come at the beginning or the end of life, and not much in the middle, but how people look after themselves during their life has a big impact on those costs. That's the part that needs to be discussed.
"I think a lot of people in the US are afraid that they [legislators] are going to take a 'quick fix' approach to what is a long-term and complex problem."
He concluded that another wider social issue that had to be addressed was public expectation about advances in medical science.
Dr Hubbard says this is brought home to him when he lectures to medical students.
"I ask them: how many of you think we understand around 80-90% of human biology? Well most of them put their hand up, but of course the reality is that we still only understand about 10% so there is a long way to go."
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