The process of bringing a compound to market is timely and expensive. Sponsors are increasingly looking to outsource Phase I clinical trials to contract research organisations (CROs) to bring costs down. Read on to find out exactly what Phase I clinical trials are and the benefits of outsourcing them.
What are Phase I clinical trials?
Phase I (often known as early stage) clinical trials are typically medical studies that test a drug or treatment that has never been used on humans before but has shown significant promise in pre-clinical trials on cultures or animals. The parameters for efficacy obviously change dramatically between in-vitro, cells or animals and human beings so a drug or treatment has to go through the clinical trial process before it can go to market for use on humans. As the drug or treatment in question has never been tested on humans before up to this point, the purpose of a Phase I trial is to test its efficacy and safety on humans.
As the risk of unforeseen effects is significantly higher than during other clinical trials, Phase I studies typically involve a small sample group of patients over a short period of time. The criteria for involvement are also particularly strict compared to other studies. This means that compensation to Phase I clinical trial participants is accordingly high and some people have almost made being a patient a full-time occupation.
Why outsource Phase I trials?
Pre-clinical testing can take several years to complete with only five in 5,000 compounds making it to the clinical trial stage.1 Of those five compounds, only one will actually make it to market.
With the increased compensation and strict regulatory requirements relating to Phase I trials, it is no surprise that sponsors are looking to form partnerships with CROs. The most time-intensive part of the studies is often finding patients that meet the stringent criteria. Delays to clinical trials cost pharmaceutical companies millions of pounds in loss of sales and outsourcing to CROs often allows them to redirect personnel and technology resource internally to where is can be most effective.
Sponsors should seek CROs that have a long-standing reputation for rapid and successful patient enrolment, often involving access to patient populations in emerging markets that dwarf available populations in the UK. This can speed up the recruitment process significantly and greatly reduce a pharmaceutical company’s risk of costly delays.