Pierre Pellier, MD

Observing the many digital applications available nowadays to assist in data generation and collection in the field of clinical research, has made me reflect on how differently we did this in the past. When I started my career in the industry as a clinical research physician in the early 1990s, paper was the norm. Most clinical studies’ data collection took place on paper. Investigators would fill in case report forms (CRF) using triplicate (or sometimes quadruplicate, depending on the appetite of the sponsor), which clinical research assistants would tear, distribute to the various study folders and carry back to the office. Besides the medical information included in the CRF, paper was also the primary tool for most of the patient-reported outcome data.

If you were working in a disease area where one could not rely on any objective measures (eg: glycemia) but rather where the primary outcome measure for your trial was based on symptoms reported by patients on a daily basis, then you had to rely on paper collection.

That is until providers began to develop digital tools that could be programmed to collect specific data, at a specific time, and provide a time stamp for data entry.

Some significant steps took place to introduce digital solutions for pre-clinical studies, data generation and collection in early Phase I studies. It suddenly became possible to generate, capture and organize healthy volunteer data automatically. This was also the time when the first electronic CRFs started to appear. Seen with today’s standards in mind, the early solutions looked a little clunky; instead of using what would now be known as cloud-based solutions, these electronic CRFs were individual computer laptops that usually belonged to the sponsor or the CRO running the study. If an investigational site was running several studies at the same time, this site may have had to store as many computers as studies. Digital solutions were also introduced in other areas, such as centralized patient assessment, image analysis and the creation of centralized reading centers.

The movement to develop and introduce digital solutions in clinical trials sped up, with more sophisticated disease area-specific solutions being developed and piloted into clinical trials. For the first time, these solutions were able to objectivize and quantify biological or physiological changes related to the effect of the intervention on the disease process, and place it into the context of the real patient’s life. For disease areas relying primarily on subjective outcome measures, these solutions prove invaluable. However, many of these remain add-ons to what is otherwise being used or collected in normal practice, which generates additional costs and complexity to deploy.

All is now changing with solutions that can be fully integrated to devices most of us carry with us, like our smart phones. These devices, which follow us almost all the time, provide a goldmine of information pertaining to our functioning as individuals. They are able to observe our daily activities, in a very unbiased fashion. Coupled with disease-specific applications, the combination becomes a powerful tool to assess how we function in healthy and diseased states. This opens the door for increasingly decentralized clinical trials, with the participation of truly empowered patients–for whom clinical trials may represent an important therapeutic alternative.

Over the last 30 years, digitization has fundamentally revolutionized the clinical trials’ process. Data generation, standardization and hypothesis testing capabilities have been hugely enhanced, at the same time the deployment of digital solutions has become easier. Data collection and facilitating patients’ knowledge, information and detection has also been a game changer. By combining real world evidence and disease specific measurement through increasingly powerful data analytics at an affordable cost, digital technologies have completely transformed the clinical trials landscape.

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Digitalization has revolutionized an industry once reliant on paper collection.

Pierre Pellier, MD

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