Real World Data and Real World Evidence: Tucuvi as an evidence generation engine

Over the past years, a transformation of healthcare has taken place towards models that are based on results and the creation of value for patients. For this reason, the demand for information from the pharmaceutical industry has increased, no only in terms of the efficacy of their drugs, but also in terms of their safety, effectiveness and clinical and economical value. This tendency is particularly noticeable when dealing with illnesses that imply high costs, such as chronic conditions.

On the other hand, one of the main challenges faced by healthcare systems is guaranteeing their sustainability. This means achieving better health results  whilst maintaining an optimal relation between costs and resources. In this sense, it is essential to have information available that can ease clinical decision making.

As the medical sector focuses more on health results, pharmaceutical companies are looking sources that go beyond randomized clinical trials (RCTs) to measure and prove the value they provide. In this sense, what we know as Real World Data (RWD) and Real World Evidence (RWE) enable a new approach to the management of clinical research, medical assistance and system sustainability.

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Real World Evidence and Real World Data: what are they?

We define RWD as the set of all the data related to the condition of patients and the medical attention they receive. This information is collected routinely from several sources, such as electronic clinical histories, pharmacological monitoring, health apps, wearable devices or clinical virtual assistants. The collection, storage and analysis of all this data allows us to generate RWE, defined as the clinical evidence for the use and possible benefits and risks of a medical product. Therefore, RWD and RWE refer to any relevant data that has not been collected through an RCT.

RWE is a highly valuable tool for the healthcare system in general, since it provides more information on diverse areas, such as illness progression, effectiveness studies, research on results or possible risks of a particular treatment.

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Value added to the technological and pharmaceutical sectors

RCTs are designed to determine whether a given treatment or therapeutic procedure works under controlled conditions, which requires very strict inclusion and exclusion criteria. For this reason there are certain circumstances that limit the generalization of the results, such as diversity in drug response in everyday clinical applications or lack of treatment adherence. On the other hand, RWE enables us to obtain data in terms of effectiveness instead of efficacy, together with additional information on the safety of real patients which are often polymedicated or are pluripathological.

RWE lets us learn how a new treatment impacts the real world, representing a broader slice of the population, with diverse age groups, comorbidities, adherences, etc. It is therefore possible to identify trends within specific population cohorts during longer periods of time and with much lower associated costs when compared to RCTs.

The main advantages gained from  RWD and RWE can be grouped into three areas:

• Regulatory authorities: RWE can be used as support to evaluate the possible risks and patient responses to a given treatment, and to monitor safety and side-effects of new drugs.
• Medical professionals: the information gained can be used to support decision making, easing the development of clinical practice guidelines. At the same time, it helps understand how the characteristics and behaviors of patients affect health results, aiding in the determination of the associated costs and progression of illnesses.
• Pharmaceutical and biotechnological companies: RWE can be applied to the design of clinical and observational trials that allow the generation of new treatment options for patients. Furthemore, it allows for the long term comparison of the effectiveness of different treatments, increasing the efficacy of investment into R&D.

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How does Tucuvi generate RWD?

Remote monitoring with Tucuvi permits an active and constant followup on patients, helping to control their clinical evolution. Patients talk to Lola, our virtual assistant, and tell her how they feel, whether they have experienced any new symptoms and how these have evolved.

Our AI and natural language processing algorithms allow us to gather, process and structure all the information given by the patient and send it to the medical teams in real time. Furthemore, our conversation protocols are completely customizable and adapt to the needs, circumstances and specific cases of all patients.

The information gained through our monitoring system therefore meets three key requirements:

• It comes from highly diverse patients with very different needs, which helps reduce bias and increases accessibility to healthcare.
• It is structured and prioritized, easing posterior analysis and allowing for the optimization of day to day clinical practice.
• The information is gathered in the form of recurrent conversations. Although it is later structured, it allows patients to express how they actually feel about different treatments or the evolution of their illness. This is highly valuable information that up until now was never gathered beyond clinical trials.

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The information extracted from the conversations between Lola and the patients can be used by different sectors:

• Understanding what patient profiles in different therapeutic areas can obtain a greater benefit from different treatments.
• Data gathering on patient experience or patient-informed results on clinical practice.
• Analyzing PROM and PREM results at scale, to evaluate the impact on patient quality of life.
• Evaluation of drug safety and efficacy, enabling comparative studies.
• Development of studies on the value and efficiency offered by a treatment in real world applications.
• Evaluation of prescription patterns of a new drug.
• Analyzing provision of services and the impact on service improvement activities.
• Measuring the use of medical services in relation to available resources and disease burden.

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At Tucuvi we continue to work to answer the demands and needs of the healthcare system, helping with the personalization of treatments. Our goal is to achieve a more efficient and accessible healthcare, increasing quality of life at home.