The clinical research landscape is rapidly transforming. Instead of viewing patients as subjects, sponsors now use the patients’ input to help reduce the burden they face during trials. This patient-centric approach is necessary to ensure that the clinical trial staff recruit and retain enough participants and it has led the industry to modify all stages of the clinical trial life cycle, from design to analysis. “What we are seeing is a lot more openness to innovations, digitization, remote visits for the patient, and telemedicine, for example,” said Rose Kidd, the president of Global Operations Delivery at ICON, who oversees a variety of areas including site and patient solutions, study start up, clinical data science, biostatistics, medical writing, and pharmacovigilance. “It is becoming a lot more decentralized in terms of how we collect clinical data, which is really constructive for the industry, and also hugely positive for patients.”
The Increasing Complexity of Clinical Trials
Accurate data is central to the success of a clinical trial. “Research results are only as reliable as the data on which they are based,” Kidd remarked. “If your data is of high quality, the conclusions of that data are trustworthy.” Sponsors are now collecting more data than ever through their trials.1 This allows them to observe trends and make well-informed decisions about a drug’s or device’s development.
However, these changes in data volume complicate how clinicians design and run their clinical trials. They must capture enough data to fully assess the drug or device without severely disrupting a patient’s lifestyle. Additionally, the investigational sites must ensure that they have enough staff to collect the data in the clinic or through home visits and keep up with their country’s clinical trial regulations. They also must develop efficient data collection and delivery strategies to ensure a trial’s success. While poorly collected data can introduce noise, properly collected data allows clinical trial leads to quickly consolidate and analyze this information.2 And they often require support with this process.
Innovative Solutions to Improve Data Collection and Delivery
Fortunately, sponsors can find that support with ICON, the healthcare intelligence and clinical research organization. “We essentially advance clinical research [by] providing outsourced services to the pharmaceutical industry, to the medical device industry, and also to government and public health organizations,” Kidd explained. With expertise in numerous therapeutic areas, such as oncology, cell and gene therapies, cardiovascular, biosimilars, vaccines, and rare diseases to mention just a few, ICON helps the pharmaceutical industry efficiently bring devices and drugs to the patients that need them, while ensuring patient safety and meeting local regulations.
One of the areas that Kidd’s team is specifically focused on is providing solutions to advance the collection, delivery, and analysis of clinical data.
The platform that ICON provides to support sponsors in this regard not only stores data directly entered into the system by clinicians during their site or home visits, but also serves as an electronic diary for patients to remotely record their symptoms as they happen. This makes it easier for patients to participate in clinical trials while maintaining their jobs and familial responsibilities. Moreover, this solution provides clinical trial staff with insights into their data as they emerge, such as adverse event profiles and the geographical spread of these events. However, this requires that the data is input into the system in the same manner at every participating site.
To address this problem, ICON’s solutions also include a site-facing web portal that helps to reduce the training burden by standardizing data capture and allowing site teams to learn key information about a drug or device. The portal also offers a visit-by-visit guide to ensure that clinicians are asking the necessary questions for a particular visit and helps them remember how to record the data correctly. “It is training at their fingertips when they need it most,” Kidd said. Solutions like these help sponsors obtain the high-quality clinical data that they need to progress from the trial to the market.
Clinical research is evolving and data strategies that support sites and patients alike must similarly evolve. With the right expertise, experience, and technology solutions, ICON is supporting better decision-making by sponsors.
- Crowley E, et al. Using systematic data categorisation to quantify the types of data collected in clinical trials: The DataCat project. Trials. 2020;21(1):535.
- McGuckin T, et al. Understanding challenges of using routinely collected health data to address clinical care gaps: A case study in Alberta, Canada. BMJ Open Qual. 2022;11(1):e001491.
