The CRO Industry (clinical research organisation)
Over the last 35 years the CRO industry has evolved from a few small entrepreneurial providers offering a pressure valve to the pharmaceutical industry to a well established multi billion industry, growing by 10-15% annually and employing around 100,000 professionals in hundreds of Clinical Research Organizations worldwide.
There has been a proliferation of companies, mergers and acquisitions which has lead to the formation of some very large multinational players employing as many as 15,000 staff worldwide. However, the market place is as diverse and as open for new ventures as it has been for decades; just very much bigger in overall size.
Unfortunately, one of the biggest drivers for the growth of this industry has been the ever increasing regulatory requirements rather than an increase in true innovation. Yet new approaches in drug development such as personalised medicines and the development of biological medicines will undoubtedly change the face of this industry. It is likely however to continue to thrive but more in terms of overall size and diversity.
Entering uncharted territories is the foundation of all research and as such requires a constantly widening range of specialists who can contribute to the new challenges within drug development.
Partnerships and close alliances have been the buzzword of the industry over many years and indeed it would seem like the logical evolution. Whilst other industries have embraced this concept it has not really materialised in the pharmaceutical research market. The processes by which clinical trial services are purchased have become smarter and more structured. The demand for standardised processes dealing with large quantities of tests and data in some areas of full drug development have created a large demand and the subsequent formation of large and process driven CROs regularly supplying the major pharmaceutical companies. However, large processing units are not the most appropriate environments for true innovation and it is not surprising that large pharmaceutical companies constantly scout for new alliances in the biotech and CRO industry.
Innovation is the product of excellence usually delivered by an individual. However, large development programmes are reliant on large infrastructures. These are very different needs that the industry has and it is unlikely that they will ever be efficiently met by any one CRO company.
However large the portfolio of a CRO may be, the forte of any large organisation is the ability to process large amounts of goods or data in a uniform way. The advantage of smaller companies is their ability to adapt to new challenges quickly and deliver true innovation. It follows that the diversity we currently see in the CRO market place is likely to continue providing the opportunities for new entrants to the market.
The increasing numbers of patients needed for trials, and the current political moves towards motivating more patients to put themselves forward for trials, does require reassurances to the public with regard to the safety of those trials. This has lead to the introduction of long awaited legislation in Europe setting a frame work for the conduct of clinical trials testing new medicines in humans. The number of regulations is likely to increase which will in turn create an increase in bureaucracy. This again will create a demand for larger organisations to process large amounts of data creating very large databases. Yet more regulations do not necessarily make research safer as the recent unprecedented tragedy at Northwick Park Hospital in London has shown. In this instance all relevant regulations were followed yet the information available was not evaluated in the appropriate way and as a consequence a far too high dose was given to a group of six previously healthy volunteers. The challenge in controlling such complex issues is to find and involve a highly specialised expert in a particular field and to ensure that all available data is evaluated appropriately in the approval process. This represents a challenge, and in this instance, again, size will not be the answer.
Innovation and research require a large arsenal of research tools and services as well as a effectively functioning network, facilitating the access to and exchange of information, both on available services and expertise. It is the creation of these knowledge based networks which will create the most exciting opportunities for the future of a diverse and thriving CRO market.
Dr Jorg Taubel MD MFPM