CROs key to successful patient trials recruitment
rising more rapidly in relation to the other parts of the R&D
process, placing greater emphasis on the recruitment of test
subjects, as clinical trial service providers become increasingly
important in the drug development cycle.
Patient recruitment and retention currently represents a critical bottleneck in clinical research and drug development. Since clinical studies account for around half of the billion-dollar cost of drug development, the use of clinical trial services is set to increase exponentionally in the future.
The report, by market researchers, Piribo, details this major trend that has seen pharmaceutical and biotech companies identify and reassess factors that play a role in clinical trials in order to maximise their investment and improve the process.
The Tufts Centre for the Study of Drug Development found that whilst total average (preclinical plus clinical) costs increased 5.8 times between the 1970's and the 1990's, the corresponding clinical costs increased 8.6 times.
"Large numbers of subjects are needed to generate high quality data that will convince regulators and clinicians, as well as future users in the general population, that a product is of clinical benefit," said Dr Faiz Kermani, European Business Manager at CRO Chiltern International and author of the report.
Companies are therefore turning their hand to external partners to help them manage their clinical trials, such as clinical research organisations (CRO's).
Contract research organisations (CRO) have benefited from the pressure on the pharmaceutical industry to maintain a flow of blockbusters at a time of increasingly dry pipelines and generic challenges to its current top-sellers.
The CRO industry's growth may have slowed from increases of around 20 per cent seen in the mid-1990s, but the more solid low double-digit growth now seen would still be the envy a pharma company.
Currently, the US forms the largest part of the global CRO market, following on from its position as the world's largest single pharmaceutical market. In fact, the US CRO market was estimated to be worth $4.2 billion (€3.5 billon) in 2003, compared to its $2.6 billion European counterpart.
Analysts Frost & Sullivan predict year-on-year growth for the European CRO market of 10.4 per cent up to 2007, when it will be worth an estimated $4.3 billion.
The driver behind this predicted growth is the increasing attractiveness of Eastern Europe to drug developers in both the US and Western Europe.
Piribo estimated that, at present, a number of multi-centre clinical trials being carried out in the CEE region is growing on average at an annual rate of 30 per cent.
The report identified dominant companies in Europe such as Quintiles, Covance, PPD and Ingenix, which have prospered by offering services from pre-clinical to clinical and into commercialisation, harnessed to entrenched pan-European operations.
These companies are also among the largest of the global CROs. But analysts expect competition in the European market to intensify as more companies look to offer this sort of range to their services.
The report said that although pharmaceutical companies may have operated on a commercial basis in emerging regions they might not have been actively involved in running clinical trials in these areas.
Partnerships with specialised clinical research organisations (CRO's) could prove advantageous as CRO's operate globally and have first hand experience of dealing with regional issues.
As CRO's work internationally across different therapeutic areas and on different types of products they can often gain ideas on new approaches to important issues such as patient recruitment.
The report predicted that with clinical trials, although patient availability and recruitment will be evaluated, other issues will include study centre and investigator suitability, local regulations and of course resources, timelines and costs.
The decision-makers must weigh up all such factors along with patient recruitment details before plans can be made to carry out a trial.
Kermani concluded that the global outsourcing focus of companies will continue and therefore knowledge of running clinical development projects in emerging regions will become a strong reason for working with a particular external organisation such as a CRO.
The paper is available from Piribo as a free download here.
