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harmaceutical and biotechnology companies are adjusting their drug development procedures and resources to address the more rigorous focus on safety and ‘real-life’ clinical experience in US and European regulations, a new report finds.

For example, in a survey conducted for the report by IMS Health, 69% of respondents from the biotechnology industry and 57% from Big Pharma said they expected to devote more resources to Phase IV post-marketing activities in the next five years, either “to a great extent” or “to some extent”.

The report, Safety First: The Impact of New Regulations on Clinical Development, was commissioned by contract research organisation (CRO) ICON and was based on a survey of 140 senior industry executives responsible for pharmacovigilance, drug safety and clinical research activities at a range of top-tier and medium-sized pharmaceutical companies, as well as biotech players, in the US and eight EU markets.

IMS Health cites recent moves by drug regulators to tighten up safety controls both pre- and post-launch, such as the introduction in May 2008 of the US Food and Drug Administration’s (FDA) ‘Sentinel’ initiative to track the performance of marketed medical products; increasing requests from the FDA and the European Medicines Agency (EMEA) for post-marketing surveillance programmes as a condition of drug approval; and the European Risk Management Strategy unveiled in 2007.

Among the report’s key findings is that, in the main, pharmaceutical and biotechnology companies believe these moves are justified. Nearly 60% of the survey respondents felt it was right for industry to accept more responsibility for safety at every stage of drug development, IMS Health said.

Around three quarters (77%) of those interviewed thought the industry as a whole would be acutely affected by new regulations in this area. However, asked about the specific impact of safety regulations on clinical trials within their own company, the respondents showed marked differences of opinion according to the type or size of their operation.

In all, 43% acknowledged that the new regulations were affecting their clinical trials to a great or to some extent. But with Big Pharma and biotech respondents the figure rose to 52% and 44% respectively, while with medium-sized companies it dropped to 32%. The discrepancy could be due to mid-sized companies shying away from high-risk therapeutic categories, or to a sometimes narrower focus dulling the impact of regulations, IMS Health suggested.

Updating SOPs

More than half of the survey participants confirmed their companies were constantly updating internal standard operating procedures (SOP) to conform with the tougher safety requirements.

The main onus appears to fall on the medical and regulatory departments, with 73% of the respondents believing the new regulations would affect medical staff to a great or to some extent, and 76% seeing the same degree of impact on regulatory functions. More than half (53%) of the interviewees stipulated a need to beef up their regulatory resources within the next three or six months.

As far as Phase IV studies are concerned, it seems biotechs and the larger pharmaceutical companies are again taking the lead. Among the biotechs, 69% said they expected to bump up their Phase IV activities to a great or to some extent over the next five years. The corresponding figures for Big Pharma and medium-sized companies were 57% and 35% respectively.

All the same, IMS Health added, the value of patient registries in monitoring drug safety at all stages of clinical development is not widely recognised, with 40% of respondents believing registries were primarily a tool for amassing information once a drug had been approved.

Patient registries “cannot (and will not) replace randomised clinical trials, but they are one answer to regulator demands for more data on a drug’s safety in the real world, with applications across all stages of the clinical trial process”, the report commented.

Indeed, it said, “earlier embracing of new approaches and solutions to the drug safety issue can offer important advantages in the longer term and potentially avoid expensive and disastrous mistakes”.

As Dr Suzanne Gagnon, chief medical officer of ICON Clinical Research, pointed out, the transition "from performing passive post-marketing surveillance to active safety monitoring using Phase IV studies, safety registries and comparative effectiveness programmes, is to ensure that benefit/risk re-assessment continues as safety information on the real-world use of products is revealed".

While it is initially resource-intensive, "this more rigorous approach to obtaining and analysing post-approval safety data will better ensure the public’s confidence in a product’s true safety profile", she observed. "The real challenge will be to find better tools and novel approaches to implement the requirements of regulations efficiently and cost effectively."