The global pandemic has many sites and sponsors more mindful of the clock than ever before. With COVID-19 trials, as well as studies centered around other conditions, researchers and other stakeholders are on the hunt for ways to launch trials rapidly and efficiently, to get therapies to patients quickly.
The IBM Clinical Development (ICD) solution is a cloud-based electronic data capture (EDC) platform designed to help trial teams speed study launches and conserve costs. The technology is already in use in a number of global trials.
In Brazil, AZIDUS Brasil CRO and Cellavita Research Lab are harnessing ICD in multiple COVID-19 related studies. These include research into the effectiveness of Nitazoxadina 600mg and Cellavita’s proprietary NestaCell stem-cell technologies.
“The IBM solution is being used in studies of great importance, in an attempt to help find new therapeutic alternatives for the treatment of COVID-19,” said Luciana Ferrara, AZIDUS Brasil CEO. “We feel a sense of urgency to identify meaningful therapies that could help support patients, particularly at a time when we are seeing the crisis escalate in Brazil.”
Global contract research organization (CRO) Veristat also is using ICD for multiple COVID-19 trials, including an anti-viral treatment study the company reportedly got up and running in just two weeks. Additionally, data-centric CRO MMS reportedly used ICD to build and launch integrated datasets for sponsor trials in three business days.
Rob DiCicco (RD), deputy chief health officer for IBM Watson Health, discussed the IBM Clinical Development (ICD) solution with Outsourcing-Pharma (OSP), including how the technology is helping studies accelerate their timelines.
OSP: Could you please tell us about ICD—what it is, how it works, and what sets it apart from similar solutions currently available?
RD: ICD is a clinical data management system with embedded modules. The core of that clinical data management system is EDC. Electronic forms that people enter info into to indicate if something’s working or not, if there’s an adverse experience, blood pressure data—anything a study is designed to collect.
The basis for why it’s different than what other companies provide is basically the same set of solutions, but within that system, there are modules for randomizing the patients. When someone decides they’re going to sign up, they’re randomly assigned to treatment or placebo, and that’s done electronically. In other systems, that function is not embedded. A patient needs to be registered in one spot, then dealt with in another.
Another thing that makes ICD unique is help with medical coding. Patients don’t come in and just give you the code for what they’re feeling. They tell you they have a runny nose, itchy skin, etc. Someone then has to record that, then code according to a standard dictionary. We have a feature that automates it, with about 80% of the searches done accurate.
One of the most important features is that it is fast to set up. That is especially important from a COVID-19 perspective. It gets up and running and relevant. Other countries that are running trials find they’re in a race against time. In a couple of places where it’s different, we host it; it’s not something that has to be integrated into a company’s systems, with a major IT integration project.
With other systems, things have to be integrated on the premises, in your environment. Our system is web-enabled, and staff and patients access from tablets or phones.
Another feature embedded is eclinical outcome assessments. With a lot of studies, you ask the patient to provide information on how they are feeling, or you ask specific questions related to the drug. This involves an add-on (separate tablet or phone), which needs another device.
With ICD, people can do it with their own device. This is important on the front end—users are able to work with tech they’re used to. The more you reduce the friction, the easier you make it for them, they more likely they are to keep up with data collection.
OSP: Why does IBM feel it’s important to partner with trial sponsors, especially in the face of the COVID-19 pandemic? Is “collaboration” a word typical to the CRO-tech provider relationship?
RD: It’s critically important to collaborate. Every company is different in a nuanced way, and it’s important to understand some pain points are common, while some are unique—it’s critical to have the kind of relationship and collaborative spirit that allows both sides to get the most benefits from this.
Integrating new tech is hard; to make that easier, and get the full benefit, it’s important to work in a collaborative environment. In the last five or so years, I’ve tried and piloted a lot of technology, so I feel I have a unique point of view in terms of what that feels like. it’s important to work in a collaborative. The last 5 or so years, tried and piloted a lot of technology. Unique point of view in terms of what it feels like.
OSP: How did you come to work with Veristat on their COVID-19 research projects? How did your technology help streamline their work?
RD: We were known to them through prior work, and they’d already used ICD. The program we had set up benefited on the cost factor side, with a real benefit from a speed point of view.
The ability to quickly build a new study enabled them to get it launched in a week or two. For a lot of mainstream studies, it can take two to three months after final protocol to be live with an EDC. Veristat’s ability to pull from libraries and reuse and templatize the study let them configure in a way that they’re used to.
Speed to start up is incredibly critical. In the COVID environment, ability to collect data remotely is important. Healthcare resources are constrained, everything has and it’s really critical to not lose study data. The ability to patients to go online to fill out information is helpful.
OSP: Please describe your collaboration with AZIDUS Brasil and Cellavita Research Lab—how are you helping those innovative clinical projects advance?
RD: We were already in discussions with them about other studies. They’d either worked with us, or they knew about us. Again, the ability to start quickly is important.
It’s typical for studies to change over time—as you implement, changes are necessary. The ability to not lose time as these updates are made is a big advantage, in a time where speed is of the essence.