February 5, 2019 | Every sample delivered at the right time, in the right quality, to the right place for analysis and for generation of data in clinical trials.

That’s the mandate for Caoimhe Vallely-Gilroy, who heads up clinical trial biosample management and informed consent for Merck KGaA, based in Darmstadt in Germany. It’s no simple task. Not only do physical samples need to be tracked and traced, but now sample data access needs to be followed as well, and every move must be linked back to the patient’s original consent.

Rather than get too caught in the weeds, Vallely-Gilroy focuses on the informed patient: making sure that the patient is fully consented and aware of what samples are going to be collected and what are they going to be used for—even when that calls for peering a bit into the future.

On behalf of Clinical Research News, Marina Filshtinsky spoke with Vallely-Gilroy about informed consent, sample tracking, and how the space is changing.

Editor’s note: Marina Filshtinsky, Executive Director of Conferences at Cambridge Healthtech Institute, is planning two tracks on the subject at the upcoming Summit for Clinical Ops Executives, SCOPE, in Orlando, February 18-21. Vallely-Gilroy will be speaking on the programs of Clinical Biomarkers Strategy and Innovation and Clinical Biospecimens and Central Lab Solutions. The conversation has been edited for length and clarity. 

Clinical Research News: What are two to three challenges in clinical specimen management in the era precision medicine?

Caoimhe Vallely-Gilroy: I think one of the biggest challenges is that a lot of our protocols are getting more and more complicated as we go along. They're not so simple anymore. There are a large number of amendments in our protocols as well, which means that you have to be very considerate and careful of the kit design for the sample collection and for the shipping schedules for vendors. I find that we have a lot more interim analysis in studies as well, which means that our samples collected, our eCRF [electronic case report form] data has to be a lot cleaner, and our sample demographic data for the actual physical samples that have been collected need to be cleaned a lot more regularly than just at the end of a study. In that respect, there are a lot more operational challenges being faced..

The other thing that I think is very challenging for us at the moment is that the physical sample is not the only commodity that we are dealing with anymore. A lot of functions value the data that comes with the sample, so the data associated with the sample becomes a commodity in itself.

What kind of data?

Things like the genetic data that has been generated, any of the clinical data that is available, any of the analysis data that is generated from the samples. We have to ensure that when we review and look at our informed consent forms, not only are we making sure that the patient is fully consented and aware of what samples are going to be collected and what are they going to be used for, but we have to make sure that they're aware of any data they are sharing for ideas that we have in the future. So that is something that we now almost have to future-proof ourselves for.

Are informed consent forms critically important when we deal with patient's direct material? Would you mind commenting on how you tackle them at your group?

They are vitally important for several reasons. Not only do we have to respect the patient’s rights as the original sample owner, we have to remember that they have donated this material and data for the good of our clinical trial. We are only the custodians of the sample, we do not own it. So it is vitally important that we treat the samples and the data, including what the patients have allowed us to do, with the utmost respect. It's important for the ethics for the patient treatment.

On a slightly more cynical note, it's important for us to treat those properly and carefully as well because of the public perception of the companies that we work for. We know that our clinical trials are getting smaller. We're running less blockbuster-style trials, so our molecules are becoming more and more specialized, which means that there's higher competition for patients. Companies need to be aware that anything done that is deemed unethical or not correct, does lead to downstream risks of losing good public perception of the company that you work for, and possibly leading to either patients not wanting to be involved in our trials or investigators not interested in running our trials.

I think we have to be very aware and more cognizant of the informed patient. We are in an era where patients are much more informed about what they should expect on a clinical trial and have more interest in their own health data as well. People are a lot more curious, and advocate for themselves a lot better than they used to. So I think that we have to be aware that we are treating this material and this data with the utmost respect. The way that I'm maintaining that at the moment is tracking. Tracking, tracking, tracking. We are in the process of building a system that allows us to track all the informed consent attributes, from a master level down to country- and site-specific levels, and across all of our amendments, and to match those up with the patient's signature date of consent and version of consent that the patient has signed, so we're able to manage that in a much more streamlined process than previously. That is something that we are looking at very, very carefully.

We're also mapping our eCRF patient development, to ensure that we have a more robust way of tracking patient withdrawal or any patient wishes that have been expressed during the trial.

Once the sample was processed and the data were derived and analysis was done, who has ownership of that data?

That is a very complicated question. The data that has been generated is owned by whomever has generated the data, so the sponsor would own the data. However, we need to look into things like GDPR, which allows the patient the right to be forgotten. Within clinical trials their own personal health data belongs to them. That is a very complex question regarding the data.

What about clinical research? Do you think that the same sample that you're collecting during the clinical trial can be used in clinical research or early stages?

Yes, I don't see why not as long as they see that the consent covers the use of the sample in new studies, and if I believe we are going to generate good quality data or data that is going to support clinical development, I think then yes. Why not use it in pre-clinical? I think these samples are extremely precious, especially some of our more complex sample matrices such as if we have ocular fluid, if we have CSF, or our tumor blocks, our tissue blocks. Those are very valuable pieces of material. I think we need to make sure that, yes, we are going to use them, but we should prioritize the use to get the most at value generated out of those samples. With the caveat, of course, that any use is covered by the ICF.

Technology and innovation by systems management in clinical trials has moved to the next level. Can you please share a couple of examples of IT use in this area?

Sure. So there is a lot of bio-banking software out there now. I think when I originally started in this in this area, there was really only maybe one or two kinds of bio-banking software that were being developed. There was a focus around the development of a LIMS system or a bio specimen tracking system within an active repository. There were fewer vendors who’ve really understood live tracking of bio specimens during the course of the clinical trial. That is where there is a lot of development going on at the moment. So real-time tracking of your samples is something that is very much in development and is going to progress in the next couple of years..

There is a big push for eConsent usage, and also eSignatures. At the moment, obviously, eSignatures are more prevalent in the U.S. and Canada than in the rest of the world. There's a lot of work going on with bringing the rest of the world on board to eSignature, and also eConsent. I'm responsible for eConsent within Merck, so we are doing our very best to roll that out across the portfolio ensuring that it does not make life more difficult for investigators and that it really does improve the experience of a clinical trial for our patients, that is our number one priority in the rollout of this system.

But also, we need to be cognizant of the fact that we're trying not to make it more difficult. We're trying to simplify and make everything more trackable, and ensure that it's a little bit more foolproof with regards to the versions of the ICFs [informed consent forms] that are being signed, and making sure that we've got a better tracking mechanism for versions of the informed consent form that has been approved per site, and per patient availability.

Bio-specimen management, laboratory services, and biobanking services are highly outsourced nowadays. What advice do you have for those trying to break into this area? What are pharma-partners, clinical trial sponsors looking for?

If you want to break into this area, put the investment in your project management team. Put the investment in the people that are going to be working with your clients. Do not underestimate the amount of resources a study will require. If you need to, put a little extra resource on it and make sure your resourcing metrics are agreed by the pharma or biotech partner that you're working with. That is my main advice. Do not underestimate the value that your project managers will bring, and do not make them work on too many projects because you will not get the quality work out of it. It is not a job that requires little time, it requires a lot of time and it's very detailed work.

My other piece of advice is to invest in technology. Don't just look at what is available right now. Speak to your pharma partner, bring in your experienced project managers and say to them, "If you could have anything in the world in a system, what would you have?" And use that experience to build a system that is really going to benefit your pharma partners.

What’s ahead for this industry? What should we be working on?

We need to look into how we better as an industry utilize the samples we collect. We're getting much better at making sure we're collecting the right samples, making sure that they're consented well, making sure that they're tracked well, making sure that they're stored well, and accessible when we need them. But are we actively pushing those sample collections to where they are going to be giving the most use and the most beneficial data? How do we benefit our patients more by what we already have? I think that is something that I, personally, am very aware of. I'm interested in learning from my colleagues to see if anybody has any great ideas of how to do that because I think that is extremely valuable.