Is outsourcing ideal for early phase clinical studies?
reputation for providing a good quality service that is carried out
by experienced staff, delivering all to budget and on time. But is
outsourcing early phase clinical studies the best solution?
That was the question posed by Dr Christopher Kirkpatrick, Head of Clinical Pharmacology Unit at Roche, who pointed out that while outsourcing had become the buzzword of late, it would be a mistake to assume that it was the ideal solution for every company and its requirements.
Global drug development spending is expected to top $105bn (€82bn) by 2010 with 40 per cent of this business expected to be dished out in outsourcing contracts.
CROs' reputation has been earned solely on the back of the quality of work they do. In explaining the advantages of outsourcing a whole program, Kirkpatrick spoke of, "off-loading all the hassle, making full use of the partner's expertise."
"It also works well if you have a trusted partner in whom you have confidence," he added.
CROs have really come into their own with Oncology Phase I studies, an often difficult and hazardous task to undertake due to the unpredictability and complexity of the disease.
Oncology Phase I studies are traditionally performed in Oncology Units and use sick cancer patients for first human exposure, because the drugs are so toxic. Often, the studies take a long time because recruitment is often an issue.
"Clinicians are used to dealing with patients, but may not necessarily be well-versed in Clinical Research and Good Clinical Practice (GCP)," said Kirkpatrick.
CROs have the primary advantage of equipping their specialist Phase I centres with experienced staff well-versed in GCP. As a result high-quality data can be produced as a result of using tight sampling and assessment schedules and accurate data recording.
However, Kirkpatrick outlined disadvantages to outsourcing such studies arguing that a complete loss of control had to be factored in with a risk of problems that would not be known about.
Additionally, the choice of sub-contractors would be out of the client's hands. Also costs may be opaque.
Pharma and biotech nowadays employ one of three models of project management, each with an outsourcing element to them.
As well as outsourcing the whole of the programme, companies have been known to retain project management in-house but out-source (aspects of) conduct.
In addition, companies can also go for project management in-house and use in-house facilities for study conduct.
"In retaining project management in-house, while outsourcing conduct, contractor may resent being used merely as a tool. This kind of strategy could also require high project management overheads too," said Kirkpatrick.
He also pointed out that retaining project management whilst conducting in-house research could suffer from the expense in creating/maintaining the facility. There was also the concern over loss of choice in placement of project.
