Data management
There are good reasons why pharma has clung a little longer than other industries to paper records and processes. Clinical trials are complex, involving multiple partners and often multiple jurisdictions with different regulatory requirements. Finding IT that can cope with that level of complexity is not easy. Yet, at the same time, technology offers a way to make trials run more smoothly and efficiently. It has also enabled a shift, prompted by the Covid-19 pandemic, towards decentralised trials – a shift that may eventually become the norm. Most pharma companies now hire a clinical research organisation (CRO) to run clinical trials. So how important is it to choose a CRO with technology that closely matches the sponsor’s needs? Running a large clinical trial requires a wide range of skills and competencies, and for most pharma companies, technological competence is only one element of the skillset. Michael Rosenblatt, clinical operations portfolio leader in Roche global product development, says that the company “chooses CROs, and other partners, based on a whole range of factors. Certainly, technological capabilities are part of the equation, but we also look at many other capabilities that a CRO has to offer.” Horneck agrees. IT, he says, is “not the key decision driver for selecting a CRO”. The questions sponsors usually ask are: “Do you know the indication, do you have scientific expertise, do you have connections to the area we are running this trial in, do you know the particular research sites, do you have CRAs that are experienced in the indication?” He has never, he says, heard someone say “we chose this CRO over that because they have this fancy IT system”.
Outcomes over process To a large extent, pharma companies are interested in outcomes rather than process, he says: “Mid- sized pharma companies such as ours just tell the CROs to use the best suitable system for our trial. We don’t care which, it just has to be good, and you have to be good in using it – that’s the normal outsourcing approach.”
Given the increasing role that eClinical tools play in the running of a trial, however, the CRO’s IT capabilities should not be ignored altogether. Typically, Horneck says, a CRO will create an IT infrastructure that is then used for every clinical trial. The quality of that infrastructure inevitably plays a part in the ability of the CRO to conduct the trial effectively. “We have to have proven evidence that the systems do what we expect them to do, in all the areas that might have an effect on data integrity, patient safety, drug supply, availability of treatments and so on,” he says. Medac, he adds,
Clinical Trials Insight /
www.worldpharmaceuticals.net
recently performed a two-day audit on IT systems belonging to one of the five largest CROs: “We were very surprised to see that we have obviously been the first sponsor to have looked in this detail into the IT organisation of the CRO.” Some technologies are now widespread throughout the industry – electronic data capture (EDC) and electronic trial master files (eTMF) are, says Rosenblatt, “a given in today’s world”. Clinical trial management systems (CTMS), enabling the documentation of all the activities relating to the trial, are also commonplace, as are interactive response technology (IRT) systems, which carry out randomisation of patients into experimental and control groups. What might become a differentiator in future is the ability to use other, newer tools, such as those that capture data through wearables.
“We have to have proven evidence that the systems do what we expect them to do, in all the areas that might have an effect on data integrity, patient safety, drug supply, availability of treatments and so on.”
Max Horneck
While technology has made it easier to run clinical trials, it can also create complexity. Because clinical trials have multiple partners and are run across multiple sites, the integration of data can be a challenge. Many systems, says Horneck, “don’t talk well with each other and there is a lot of manual data transfer still in place”. The organisation CDISC has developed data standards that have made it easier to exchange data between different systems and different organisations. Some vendors also promote integrated platforms, comprising multiple systems that purport to work seamlessly together, though in practice they often don’t live up to their promise, says Horneck. The ability to handle integration well can only become more important, as clinical trials become more and more digitised. “The key,” says Rosenblatt “is that we need to be able to ingest data into our systems with minimal effort.”
Accelerated adoption
It seems likely that, as the complexity increases, sponsors will become more focused on the technological capabilities of CROs. In 2020, the Covid-19 pandemic forced the sector to change the way clinical trials are run, bringing technology centre stage. Some argue that by the time Covid-19 struck, the change was well underway. As Rosenblatt says: “The pandemic increased the use
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