3 Top Tips for Addressing Pain Points in Early Phase Clinical Trials

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Andrea Charles

In part two of this interview Dan Sfera from The Clinical Trials Guru, speaks to Andrea Charles from Pharma IQ, about addressing pain points in early phase clinical trials and a dramatic transformation in healthcare delivery. Did you miss part one read here: http://www.pharma-iq.com/clinical/articles/fda-concerned-about-lack-of-pi-oversight-in-early/

Pharma IQ: Using free clinical data to predict clinical outcomes is a key success factor in the success of phase-one trials. What strategies or solutions exist to ensure that this pre-clinical data is as robust and accurate as possible?

D Sfera: There's really no way. I mean, that's why they do the phase-one trials. But the biggest hindrance is actually the study participant recruitment because for every day... on average, for every day that a clinical trial goes over the expected enrolment window that's an extra $1 million for the CRO and the pharmaceutical companies to absorb. So they really need to get more innovative, if they can get more innovative. I really hate using the term innovative because in this industry you're really not allowed to do much innovation without trying through any of the FDA or the regulatory agencies. But if the innovation is going to come from anyone it definitely needs to come from the pre-clinical phase of the clinical trial.

Pharma IQ: Ten years from now, do you think that we'll really see a dramatic transformation in how healthcare is delivered?

D Sfera: It's going to be different. I don't know how dramatic it's going to be because these things take place over decades, so by the time it actually is upon us we're really not going to realise that it even happened. So it's not going to be dramatic. The changes are happening. For example, with these preferred sites, it's actually been going on for years, just informally, and they're only talking about starting to do it formally now. So we're really in our seventh or eighth year of this thing, so it's not a shock to those of us in the industry. So the same thing with the method of healthcare and healthcare delivery, I think it's going to be a story that plays out over the next decade.

Pharma IQ: And what are some of the difficulties with personalised medicine and how can this be overcome in clinical development and trial design?

D Sfera: It's going to become like everything else. The pharmaceutical companies, they're job is not to make us feel better or cure illnesses, their job is to move their stock. So it doesn't make business sense, financial sense for them to do something. They're going to try to push it off for as long as they can. So the gene therapy, individualised, personalised medical care is something that's nice. It's something that does exist now. It just costs hundreds of thousands of dollars for those who can afford it.

And for the rest of us, you know, we've got to take the medications and the pharmaceutical drugs that come out, and those are not necessarily personalised, but they try to fit in most of us to taking those type of products. So I think it can happen, but at the end of the day it's all about economics.

Pharma IQ: The industry's also seeing an increase in academic partnerships. What is the value in driving clinical innovation forward?

D Sfera: Whether these large academic institutions, the more prestigious institutions, for example, like a Harvard or a Stamford, can they conduct a clinical trial more efficiently and at a lower cost than a private industry? Across the board from most of my sources the answer is no. I mean, we can even get into the IRVs, the institutional review boards, and how different the private companies can deal with the IRVs, as opposed to the academic institutions are pretty much handcuffed sometimes by their local IRV.

So what I've personally seen, many investigators from the world of academia open their own private clinic because they're so frustrated by the local IRV. And then you get into the issue of cost. Can an academic institution save pharma money? And in most cases it's no. They take longer to get started on a study, they require more researchers to conduct the study and they definitely cost a lot more.

Pharma IQ: What would be your top three tips for addressing pain points in early phase clinical trial?

D Sfera: Yes, definitely patient recruitment, I mean, for some of these trials, and they're increasingly getting harder to recruit subjects for. And then investigator expertise, we've seen in the last several years many investigators in the United States, and I'm sure across Europe, close their companies down. There was a year... there was a gap between 2008 and late 2011, maybe as early as 2012, where there were just... there were just not enough studies coming into the pipeline of these drug and CRO companies for investigators to just decide to keeping their doors open. So we saw a lot of these private clinics, especially phase-one clinics, forced to close their doors. So that's another bottleneck, is getting new investigators up and running.

And then finally, just finding the right partnership between CRO and their preferred research clinic. They've basically had to start all over again for the phase one. There's been a lot of consolidation where CROs would acquire another larger phase-one trial... site. So that's definitely another bottleneck, is just the integration of these mergers that have occurred over the past few years.