Outsourcing favoured for Phase IV research

Even though the most large companies (80 per cent) have the means to handle Phase IV activities in-house, 57 per cent still choose to outsource much of their post- marketing operations, according to a recent survey conducted by Cutting Edge Information.

"Fluctuating Phase IV workflows is the main reason for this,"​ John Hess, Research Team Leader at Cutting Edge Information told Outsourcing-Pharma.com.

"Firms do not want to have to keep changing staffing levels due to these work fluctuations and it is more cost-effective to keep a baseline infrastructure for these studies in-house and outsource the excess capacity."​

In addition, outsourcing is favoured because otherwise companies would have to establish a single department to handle all Phase IV studies, as opposed to separate units within each therapeutic area, and for companies that operate in several therapeutic areas, especially ones that are quite different or unrelated medically, it can be quite inefficient to try to run all Phase IV research from a single unit that attempts to serve all of a company's therapeutic areas or franchises, Hess explained.

Meanwhile, for many companies, particularly small firms, outsourcing is not even a choice, simply due to resource and capacity constraints.

Of the companies surveyed, only 44 per cent of small companies and 40 per cent of mid- sized companies have the internal infrastructure to support Phase IV management.

As a result, 68 per cent of small companies and 80 per cent of mid-sized companies outsource their total Phase IV workload, said the report, titled: "Phase IV Clinical Trials: Post-Marketing Study Management Structure, Strategy & Benchmarks".

And with nearly two-thirds of all new drug applications (NDAs) approved in the US having at least one Phase IV commitment attached, this is good news for contract research organisations (CROs), who are the main beneficiaries of the outsourced work.

The Phase IV research market is already said to be worth $12bn (€9.3bn) and currently growing at an estimated 23 per cent each year, with new starts of Phase IV research exceeding newly initiated studies in all phases of clinical trials combined.

Meanwhile, the incidence of outsourcing varies considerably according to therapeutic area. CNS/Psychiatry, oncology, haematology and endocrinology are areas that are all outsourced regularly, in comparison to areas such as respiratory, autoimmune and infectious diseases.

"It is likely that there are some CROs that have become very adept at running trials in some particular therapeutic areas, and that may be why companies tend to outsource more in certain therapeutic areas than others,"​ said Hess.