Oncology drug testing - hospital vs CRO
Phase I oncology drug trials in order to improve efficiencies,
delegates heard at Pabord 2006 in London.
The new generation of low-toxicity cancer drugs coming through the pharma pipelines is now making this possible, said Chris Kirkpatrick, head of the Clinical Pharmacology Unit at Roche Products.
Traditionally, Phase I trials for oncology drugs are carried out in hospital oncology wards using sick patients so as not to expose healthy patients to the potentially highly toxic effects that many anti-cancer drugs have.
"However, these days, many new cancer drugs, such as monoclonal antibodies, have an acceptable risk/toxicity profile and may be suitable for testing on healthy volunteers," said Kirkpatrick.
"This is opening up a whole new opportunity to improve the running of these trials - by using healthy patients sponsors could recruit a larger and more uniform patient population, with no pre-existing disease or concomitant medication, and could move the trial location from the ward to a specialised clinical pharmacology unit."
Carrying out clinical trials on hospital wards can be cumbersome and time consuming as it creates a lot of extra work for the already overstretched hospital staff, said Kirkpatrick.
"It also often takes a long time to recruit patients, and the trial dosing and sampling etc. has to fit in around the other routine ward work," said Kirkpatrick.
"In addition, hospital clinicians and staff are not necessarily experienced in good clinical practice (GCP) and clinical research, and this can cause problems with the collection of data."
On the other hand, Kirkpatrick believes CROs are perfectly set up to run clinical trials as efficiently and accurately as possible.
"They have experienced staff who are able to completely focus on the trial and they are able to reliably produce high quality data through tight sampling, accurate recording and reliable transmission," said Kirkpatrick.
The downside of using healthy volunteers is the inability to demonstrate efficacy or proof of concept, and of course, as the recent Tegenero disaster proved, researchers need to be absolutely certain that the toxicity risks are acceptable.
