Models of early phase research management - pros and cons

This was the message from Chris Kirkpatrick, head of the Clinical Pharmacology Unit at Roche Products, speaking at the recent Pabord show in London.

The first option is to outsource the whole project to a clinical research organisation (CRO); the second is to retain the project management in-house while outsourcing all other functions to one or more CROs; while the third choice is to keep the whole project in-house.

"Advantages of outsourcing the entire project are that companies can gain new expertise that they don't already have in-house, while offloading the hassle that comes with running such a project,"​ said Kirkpatrick.

"Small firms may not even have any choice but to outsource the whole project due to capacity and infrastructure shortfalls."​

The downside of this approach, said Kirkpatrick, can be the loss of control over both the project and the subcontractors used by the CRO, as well as an opaqueness surrounding cost structure, as CROs usually charge a fixed cost for the whole project completion without a transparent breakdown.

"However, loss of control does not necessarily have to be a concern if companies are able to find a CRO they can trust and work together with well."​

Choosing management option number two allows firms to keep overall control of the project while offloading the detail, and many companies opt for this strategy if possible, said Kirkpatrick.

"Companies who chose this route also retain the flexibility to select what they believe are the best and/or most cost-effective contractors to use for the different parts of the project."​

"Things to watch out for though are resentment on behalf of CROs who feel they are being undervalued in the partnership, as well as a sharp rise in in-house project management overheads from having to supervise the contractors closely,"​ he said.

Bearing in mind that only three pharmaceutical companies in the UK have their own in-house research facilities, the third option isn't feasible for most, although those who can afford to do so have the peace of mind of retaining complete control, said Kirkpatrick.

They also have the benefit of working with familiar infrastructure, standard operating procedures and staff members and the trial investigator can contribute to project and protocol development. Costs are also transparent.

Of course there are downsides, including the expense of having to either create or maintain the facility, the loss of choice in the placement of the project, as well as the possibility of the sponsor and investigator relationships becoming too cosy, Kirkpatrick pointed out.

Its up to firms to sift through the various pros and cons and implement a strategy works best for them.