As clinical studies get more complex and pressures to deliver increase, trial sponsors are seeking more efficient ways to execute studies.
The use of data to drive smarter decision-making is an important way of delivering a study’s end goals. But with so much talk in the industry surrounding data, deciphering what matters is essential.
When it comes to clinical trials, combining patient records and investigator performance with other routine information can provide significant insights. By linking these datasets, it is possible to conduct research at a speed and scale that outperforms industry norms.
Supporting clinical trials with actionable data
According to Covance Data and Technology Organisation senior director of clinical informatics Michelle Jones: “Data can support a trial’s end goals by facilitating more efficient and effective selection of sites and the identification of patients who meet the criteria for the clinical trial.
“Since Covance runs approximately 50% of all the clinical trials in the world and LabCorp, our parent company, draws blood from about half the population of the US, we have detailed laboratory results from over 150 million individuals in our LabCorp database.
“We are the only organisation in the industry that has this vast volume and powerful combination to help our clients design more efficient trials and accelerate their trial recruitment.”
In addition to data on sites and potential participants, Covance also offers voice-of-patient information from their extensive Patient Intelligence Database which provides insights regarding patient tolerances to participate in clinical trials. The data spans 20 indications and is accumulated from 30 different countries.
Voice of patient data helps to zero in on patients with the best chance of participating and remaining in a study and aids the design of trials which are more convenient for those living with a disease. For example, this data is used to fine-tune site selection by understanding how far patients are willing to travel to an investigator site.
It is this combination of datasets that provides Covance clients with unique insights and strong, viable protocol designs for studies with faster patient enrolment, more patients per site and fewer non-performing sites.
“When we identify sites, we’re focused on producing a country-wide distribution that will efficiently meet timelines,” says Jones. “If you’re trying to beat the timelines, a sponsor could simply add more sites. But then you’re doing it faster with twice the number of sites and it’s not cost effective.”
Beating historical industry performances
Unlike other contact research organisations (CRO) that use prescription data, Covance is able to analyse 30 billion test results from over 150 million American lives together with their ICD10 diagnoses codes for its clients. This significant dataset enables the company to identify people who match a sponsor’s trial eligibility criteria whilst accurately evaluating the impact inclusion/exclusion criteria will have on the available patient pool.
“Our clients select Covance, because we generate more clinical trial data than any other company in the world,” Jones explains. “Our analytical experts are able to then turn this into high-value insights surrounding investigator performance across a number of key patient recruitment milestones and metrics to set our clients trial up for success.
“For example, there was a sponsor who awarded their trial on metastatic breast cancer to another CRO. A year into the trial, they came back to us because the trial needed to be rescued. We changed the sites chosen which, according to our data, were not the highest performing sites for that particular indication, and put the trial back on track.
“By taking advantage of our large datasets, we were able to add more productive sites to this client’s mix and get their recruitment on schedule quickly.”
Another client was facing challenges in recruiting 2,700 patients within a narrow timeframe for a suite of registration studies while getting international sites up and running. Covance helped this client leverage its historical investigator database to identify and secure the highest performing investigators and their current site capacity in the indication.
Extensive feasibility outreach and site capacity assessments meant that efficiencies could be identified, enabling effective overlapping of sites across the programme and resulting in an accelerated site start-up and reduced clinical costs.
The client achieved its first patient in (FPI) requirement ahead of schedule for all studies in the programme, beating the historical industry performance across a number of key metrics, including 18% fewer weeks from final protocol to FPI and 75% more high-performing sites.
An unrivaled combination of data and actionable insights
By leveraging data and increasing access to potential participants, it is possible for clients to accelerate a trial by applying critical insights across multiple therapeutic areas and indications. This leads to improved protocol designs, better patient recruitment and retention and ultimately, getting medicine to patients faster.
Clients that take advantage of Covance’s exclusive industry data can more accurately identify high-performing investigators and clusters of eligible patients to benefit a trial. They are also able to realise minimised study costs, reduce time-to-market, and improve forecast accuracy.
What’s more, with the continued growth of datasets and ongoing developments in genetic data, it seems the potential to accelerate clinical trials has only just begun.
For more information on how you can accelerate your next trial, contact Covance.