Development of clinical trials and biobanks
Professor Hani Gabra – Imperial College London, UK
One of the big problems with the clinical trials is that when they’re driven in a way that answers a single endpoint without giving much about the molecular information, when those trials are built around targeted therapy, which is the new way of targeting cancer, target specifically, we need to get more information that allows us to work out which patients will benefit and which patients will not benefit. That’s quite hard to do unless you collect tumour material from those patients at the time of the trial. So the signature of EUTROC clinical trials is that we attempt to do sequential biopsies from the tumour that the patient has so that we see, before and after some time on the drug that the trial is providing, what the impact on the tumour is from using that drug.
What are some of the issues that have arisen in the system?
Ovarian cancer is not the most common of cancers and therefore we need to have many centres working together, usually internationally in order to get the answer to a question. Now when different centres work within a clinical trial it’s important that they work to the same standard, particularly when they are trying to do something like biopsy the patients within the trial. So this has been a big barrier to work to a single operating protocol to make sure that, for instance, the biopsies are done from the same sorts of places, that they’re frozen according to the correct protocol so that the quality of the material is as high as possible from within the trial so that we can make the correct inferences about what the drug is doing.
What effect will this have on clinicians?
Already, since the first EUTROC clinical trial, it has sprung off a bunch of clinical trials, four or five, and indeed two big national and international projects where this re-biopsying for molecular analysis is happening now, which has changed the way that we actually approach the patient in the clinical trial setting.
Have there been any problems implementing these procedures?
We tried to do this clinical trial approach with biopsying actually many years ago and found a very poor uptake. The notion at that time of taking the tumour when the patient first presented and just even freezing a bit of that proved to be extremely difficult to achieve. So we’ve had to change culture and the best way to do that is to create the EUTROC Group who are a bunch of clinicians and scientists who have self-selected in order to do this approach. We found that ethically there was no problem with biopsying, either with the ethics committees or with the patients and in our first clinical trial we biopsied 100% of patients. When you explain to a patient that you can’t work out whether the drug will be helpful or not unless you have tumour material, they tend to say, “Well of course you must biopsy. Why would you not?” Indeed in the first trial with 58 biopsies done we saw only one minor complication. So we have shown that it’s feasible in 100% of patients, not only that, it’s highly acceptable and it’s of low risk to the patient.
What were some of the highlights from this meeting?
I have to say that this was a most exciting meeting and it was very refreshing. It was a small group of people who really felt strongly that they had to make the difference to patients and to do translational trials properly. This time, which was the fourth EUTROC meeting, they flocked from all over Europe and actually from beyond. We were amazed to see how many interested and motivated clinician scientists and scientist clinicians were there, all focussed on the same idea of personalising medicine and using these new targeted therapies in the best way possible to help patients in the future.