We spoke to Dr. Diana Sims-Silbermann, Senior Trial Manager of Early Development and Clinical Pharmacology at Janssen, as part of PCT TV at Partnerships in Clinical Trials Europe (Nov 2017) about the difficulties in finding suitable investigative sites for clinical trials and the added complications of regulatory requirements. Here we pick out the key highlights, or you can watch the full interview below.
What challenges are there in finding suitable investigative sites?
DSS: 'I work in early development and our trials are first-in-patient trials, so we have the problem that we have a Phase I type protocol with intensive activities, PK days and many questionnaires, and we have to do this type of a trial in patients.So we need on the one hand a very experienced group of site staff - the study nurses and investigators - who are able to perform Phase I type trials. On the other hand, the site needs to be able to accrue our patients for us. That's a big problem.
In Germany we have identified several universities that have their own Phase I units that are able to carry out these Phase I type protocols and at the same time are able to accrue patients by liaising with different departments of their university clinic.'
More generally what do you see as the biggest challenges facing clinical trials at the moment?
DSS: 'I've been doing clinical trials now for 15 years - I started as an investigator at a CRO and then I went into managing them for our firm. In that time, the way of conducting trials has changed so vastly because of the added regulatory requirements that we have to fulfill. It makes conducting these trials extremely complicated and difficult.
With the need for documentation for instance, it's just like a never ending process. Somebody is always requiring a confirmation of something you have done, and a confirmation of the confirmation. On the one hand I can understand that we want to make the data that we produce as transparent and as valid as possible. On the other hand, it is a tremendous task for the Sponsor and the site conducting the trial to have to conform to all these regulations.'
What technologies do you see as having the biggest impact on clinical trials in the near future?
DSS: 'The digitization of acquiring data; the movement of having the patient get a smartphone and be able to enter his data daily instead of having to come to the site to take a questionnaire or to report his adverse events. This is a tremendous help because these protocols often require patients who are ill to come more often than might be necessary to the site for check-ups that could be done at home.
Even tracking their blood sugar or blood pressure; if it was possible that they didn't have to come to the site to get this done, it would be a great improvement.'
Would these results be as reliable as if the patient came to the site?
DSS: 'The system has to be validated, that is a problem. And of course it has to be not only valid, but all the data has to be uniform, so everyone has to report with the same tool. That is the challenge we have to get over, but still there's a lot of things that can be done. Even just asking the patient daily "did you take you medication? How do you feel? Do you have any side effects?", could be done digitally.'