The tragic clinical trial at London's Northwick Park Hospital by Parexel/TeGenero in March - and last Thursday's BBC2 programme Drug Trials: The Dark Side - have thrown a spotlight on the little-known world of clinical trials and contract research organisations (CROs).
The drugs industry can only expect more public scrutiny of this nature, and will need to prepare itself to be able to respond appropriately.
CROs conduct clinical trials at Phase I (human safety trials), Phase II (small-scale efficacy trials), and Phase III stages (large-scale efficacy trials). It is a highly regulated industry, but a highly pressured one - the sooner a drug comes to market, the sooner pharmaceutical companies can see a return on their research and development investment.
The CRO industry is often the silent partner to the well-known pharma firms, but its value - and hence its influence - is growing at exponential rates.
The value of outsourced clinical trials was around $9bn (£4.9bn) in 2001 and is estimated to grow to $36bn globally by 2010 - an annual growth rate of more than 16 per cent, according to US clinical data monitor Centerwatch. The number of patients involved in clinical trials worldwide was estimated to be seven million in 1992. By 2001 it had reached 20 million and numbers are expected to top 40 million by 2010.
No public face
So why don't we hear more about CROs? Well, although many are large companies (the bigger ones having hundreds of operational staff), many do not even have a press office for dealing with public or press enquiries, and certainly do not retain a PR agency.
From my experience of working on three sides of the industry - for a large CRO, for pharma companies, and in communications - it is clear that the sector has done relatively little in terms of cultivating its public profile.
Following recent events, more of the larger CROs, as well as those specialising in niche markets perceived to be of higher risk (such as biological agents), are likely to beat a path to the doors of advisers - those counsellors that can get to grips with CROs' unique position in the drug development market.
CROs need to consider or reconsider their comms needs and how PR can help build relationships, understanding, trust and reputation - all of which feed back to supporting their business objectives. The repercussions of the Parexel/TeGenero trial - and the BBC programme on alleged exploitation of 'volunteers' in India - are likely to be felt across the industry, not just by a few companies, nor just in relation to Phase I trials.
Pharma companies will certainly evaluate their outsourcing programmes to ensure they have CROs in place that can meet the highly demanding standards required: it therefore falls to the CROs to be more proactive in communicating to their clients that they are up to the challenge. At a public-affairs level, companies will need to lobby government and regulatory agencies effectively.
On a similar theme, all trials rely on volunteers, so CROs - with their clients - must communicate more openly with the public about their trial processes. Strict regulations as well as client confidentiality prevent CROs from communicating directly with prospective patients about the trials they are running. However, there is no restriction on CROs disseminating more general messages about what they do, how they do it and how successful their trials have been.
In recent years the CRO industry has attracted a significant amount of investment, with share prices overall making significant gains. Therefore, as most CROs are publicly traded, investor relations is also an area to be addressed to ensure that confidence in this sector is maintained.
Clinical trials are a major step in gaining market access for a drug, and promotion of them can be used to prepare the ground for a product's launch. This would offer early opportunities for developing comms with a wide audience, including physicians, regulators and patients.
Early brand recognition can count for a great deal - this may mean branding the trial as well as the product to create early chances to target key audiences such as prescribers, i.e. physicians. Every brand message counts - and can never be too early.
By its very nature, the CRO industry is secretive, as sponsor companies restrict the information that CROs can release about individual trials. But there is now a significant opportunity for CROs to come out of the shadows, and let the professional and public audiences know more about their industry, and why they are so important in the development of new therapies.
The Parexel/TeGenero case has raised the profile of the CRO industry to a wider audience - whether they like it or not - and this cannot, and should not, be ignored. A proactive approach to comms and PR from the industry would at least be a first step to a level of openness that has until now been somewhat limited.
Those CROs that see this as an opportunity and adopt a higher level of openness with their multiple audiences are the ones we will hear more about. Those that see it as a threat from which to hide will remain relatively anonymous. Which of these would you choose for a clinical trial?
David Noble is MD of two of Hill & Knowlton's healthcare businesses - Medical Knowledge Group (med ed) and Healthcare Strategic Consulting. Prior to H&K he was commercial director with a large CRO, and spent several years as a drug development biochemist.5 OF THE WORLD'S BIGGEST CROs
World's largest CRO, based in North Carolina, it opened a UK office in 1987
Global presence 50 countries
02. MDS Pharma
Canadian group based in Toronto
Global presence 25 countries
US group based in New Jersey began operations in the late 1980s as Corning and changed name in 1997
Global presence 18 countries
North Carolina-based firm started trading in 1985. In June last year it was chosen by Merck as a preferred supplier
Global presence 27 countries
Boston-based firm was founded in 1983 and opened a UK arm in 1989
Global presence 36 countries