Paola Kruger
EUPATI
@eupatients

he past decade has seen the impressive growth of patient involvement in healthcare, to the point that the term “patient centricity” has been introduced steadily in all patient-related activities. This is particularly true in clinical research, where patients have gone from being just passive recruited subjects to active participants thanks to the realization that if something is meant to benefit the patient, then the patient must be included in the process and his/her voice must be as heard and relevant as other stakeholder voices to develop better quality medicines that truly improve their lives. The importance and impact of the patient perspective in drug safety reporting is now emerging.

Much effort has been invested in developing new methodologies for collecting the patient perspective along the clinical trial journey; as a result, patient-relevant outcomes are an integral part of today’s COAs (clinical outcome assessments) side-by-side with medically relevant outcomes. Even more interesting is the fact that EMA, FDA, and other regulatory agencies are encouraging patient involvement in clinical research. FDA has gone as far as publishing a series of guidance documents on how to involve patients in research that are shaping how the pharmaceutical industry is rethinking its approach to patient participation in clinical trials.

In this evolving scenario, pharmacovigilance has not been a top experimental ground for patient participation. On one hand, this is an area where only healthcare professionals have the right competence to deal with adverse events and the associated risks; on the other hand, patients have not been encouraged to play a more active role on this issue. Until recently, the most important objective of pharmacovigilance has been the detection and reporting of serious side effects, a task well-accomplished by current, highly evolved pharmacovigilance systems designed to guarantee patient safety and quick response to any alert.

However, with an increasing number of drugs being approved on the basis of shorter trials that involve fewer patients, getting accurate reports of adverse events and side effects after approval is becoming a necessity. Confirmation of this trend is not difficult to find. Consider how much importance real-world evidence (RWE) has gained in regulatory evaluation: Reports coming from patients which describe their experience, including minor adverse events, with a new drug will likely play a bigger role when regulators discuss and decide on granting approvals in the future.

A study conducted in the UK, which evaluated the effect of patients’ reporting on signal generation, demonstrated that combining patients’ reports with healthcare professionals’ reports resulted in the generation of 47 new signals for serious adverse drug reactions (ADRs). However, patient direct reporting in pharmacovigilance does not just add to the quantity of relevant information (i.e., the amount of information we collect) but also to its quality.

This is because doctors often underestimate certain side effects and overestimate others in terms of their importance or relevance to the patient’s daily life. This could be because the doctor’s focus is on treating the patient’s disease while the patient’s concerns could at times focus more on their quality of life than on the disease itself. For example, a low-intensity itch with no serious health repercussions might seem perfectly endurable by most observers (doctors included); but when it occurs almost daily, this same itch might eventually lead to the patient giving up his/her treatment plan. Even minor adverse events should be taken into careful consideration. This is one area where patients can play a leading role by accurately reporting and highlighting the impact these events actually have on their lives.

Even when minor side effects are reported, doctors and patients report them differently. Patients’ reports are more focused on the subjective impact of the adverse event, while reports from health professionals include a lot of clinical information but less on the patient experience.

The value of patients’ direct reports can be summarized as:

• They give more and better context than indirect reports from professionals
• They commonly describe the impact on people’s lives, which clinicians rarely note
• Indirect and direct reports complement each other, generating multicultural knowledge
• Knowledge of ADRs and their importance accumulates faster in drug safety communities
• Patients become active participants in their care
• Patients learn how to manage their medicines and to communicate better with professionals.

In pharmacovigilance, as in all areas of medicine development, the more active role of patients results in innovation and more relevant information that contributes to making their drugs safer and potential side effects more manageable in their daily life.

The best way to encourage direct patient reporting in pharmacovigilance is to attach more value to what patients say and work on better ways to engage them more in the whole process.