When it comes to clinical trials, technology has enabled contract research organizations (CROs), sponsors, and physicians to better understand the patient population and the complex clinical trial at hand, according to Carla Balch, CEO of TransMed Systems.
Many companies have seen the rising use of technology as an opportunity for the data to do the work, so researchers can focus on the science. Recently, Medidata partnered with Cognizant to develop services to reduce barriers to clinical trials, such as patient matching.
While eligibility is a large part of clinical trial recruitment, availability is just as great. Clinical software can provide the industry with the ability to understand who can participate and when. “Now with technology not only can research staff screen better and screen faster but can screen in a more timely way and come up with real matches for sophisticated trials,” Balch told us.
“Using predictive analytics we can tell when certain types of patients can be available, this is a huge shift in the way we do things right now,” she explained.
Balch said predictive analytics software can help those running clinical trials understand the types of patients that will walk into a specific site – and when.
Using data directly from patients or their electronic health records, predictive analytics help researchers foresee where clinical trials should be available and at what sites.
“So, unless something really odd happens in the next six months, we would expect to see the same stratification of patients coming through the door of a trial site, therefore the trials that should be planned in the next six months should look like a mirror for those patients,” said Balch.
Additionally, the implementing of cloud-based software can enable sponsors and stakeholders in the industry to understand the patient population, “The net effect is that pharma can now open clinical trial sites because they know the patients are there,” she added.
The transition to clinical software: ‘Paper is not helpful’
Companies are trying to transition the current, often paper-based, clinical workflow to depend on clinical trial software. Likewise, the clinical software companies are looking to understand the patient population and how best to match patients to clinical trials.
Balch explained that in some cases the lack of software use can lead to patients being precluded from clinical trials. She gave us an example of an oncology patient going through therapy: “The clinical staff is looking for a progression of the disease, and they might do things like a CAT scan or a PET scan looking for a progression of the disease. If they see it, there is usually a great urgency to move the patient off their current line of therapy to a new line of therapy.
“The danger in that is if there’s no use of technology in that juncture right there a patient can get moved from one line of therapy to another when a clinical trial opportunity was missed as a next step treatment option.”
Balch added, that clinical trial software allows users to be aware of all data points of the patient so that “at every juncture, a patient is at least looked at for a clinical trial.”
The transition though is still difficult, but the use of technologies like electronic data capture (EDC) is becoming imperative. “Paper is not helpful, that is for sure,” Balch said. “There are pieces of paper, there are faxes, so while we do live in the world of electronic medical records, there is still a lot of information that needs to be in the digital sphere.”
Having access to this information is vital for patient evaluation and trial matching, “you just couldn’t do it without technology,” said Balch.
“Our whole goal at the end of the day is to create a single source of truth; de-identified, HIPPA compliant, but a very transparent space where all stakeholders in health care can look in and see a non-spin version of health care data, that would allow them to make their decisions,” she added.