CRO supremacy in clinical research raises concerns

By Emilie Reymond

- Last updated on GMT

Related tags Clinical trials Contract research organization

While contract research organisations (CROs) now dominate the
clinical trials market, questions are being raised about the risks
of 'commercialising' clinical studies, according to new research.

According to a new report to be published in the New England Journal of Medicine (NEJM), despite CROs enabling drug makers to save time and money on their drugs' development, recent drug trial disasters have led the industry to raise questions about their accountabilities and the degree of independence from their pharmaceutical clients.

There is no doubt about the fact that CROs have the lion's share when it comes to conducting clinical studies on behalf of pharma companies; taking over academic groups, by offering greater speed and efficiency in running studies.

As a result, annual CRO industry revenues have skyrocketed from around $7bn in 2001 to a whopping $17.8bn today, and according to Thomson CenterWatch, CROs played a substantial role in 64 per cent of Phase I, II and III trials in 2003, compared to only 28 per cent ten years earlier.

However, recent events are putting a question mark on the benefits of relying on profit-driven firms to run clinical trials and whether it is in the best interest of science or the public.

Miriam Shuchman, author of the NEJM article called " Commercialising Clinical Trials - Risks and Benefits of the CRO Boom ", gave several examples of CRO-managed trials that went wrong, including the infamous TeGenero trial in 2006.

Parexel was at the centre of the drug trial disaster last year after six out of eight men involved in Phase I trials - run under contract on behalf of small German biotech firm TeGenero - experienced a severe and systemic adverse reaction and were admitted to intensive care within hours of taking the experimental drug.

Inspectors for the British Medicines and Healthcare Products Regulatory Agency (MHRA) found that a Parexel physician involved in the study had inadequate training and experience and that Parexel had no formal system in place for providing round-the-clock medical coverage, although it was later concluded it was highly unlikely these deficiencies caused the events.

"Industry observers say that such problems stem in part from outmoded norms that emphasise speed at the expense of quality and from drug regulations that were written in the 1970s, about a decade before the contract research industry emerged, and thus don't really address CROs' accountability," said Shuchman.

Indeed, the article said, according to Rachel Behrman, director of the Office of Critical Programmes at the Food and Drug Administration (FDA), the nature and extent of regulators' authority over CROs was uncertain and "it is not clear whether their accountability is through the sponsor or directly to us".

However, recent event do not seem to have impacted the high level of reliance on outsourcing that pharma companies are showing.

The main reason is that using a CRO to run a clinical basically means that the study will be finished more quickly compared to conducting it in house.

But according to Shuchman, this raises another concern about the quality of the service provided as some worry that " greater speed means inferior results ".

Inadequacy of the workforce, too much focus on the data and on doing the work as fast as possible are cited as barriers to a higher quality research.

Shuchman explained that an alternative model, the academic research organisation (ARO) avoided some of the issues around workforce qualification but were considered less efficient than CROs.

She concluded saying that given the dominance of CROs in the clinical trials arena the flaws in the model will need to be remedied.

Although, it is still uncertain how these issues can be fixed in practice, and the growing number of CROs taking advantage of low cost destinations such as Eastern Europe and Asia to conduct clinical trials could make the process even more difficult.

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