Real world evidence (RWE) is vital as a follow up to initial research and clinical trials. It takes clinical and controlled conditions further and, as the name suggests, places them in the real world. It allows for further evidence to emerge in lifelike situations.
Research is of great importance to the medical world and society. It provides vital information about disease trends and risk factors, outcomes of treatment or public health interventions, functional abilities, patterns of care, and health care costs.
Clinical trials are undoubtedly the best way to assess whether a drug or treatment works, however, once out of clinical conditions it’s more difficult to monitor and record any emerging trends and data.
Information that can help us improve this situation is real-world data (RWD), which is collected outside of a clinical trial. This can include electronic medical records, medical charts or medical claims data, which removes patient identities for privacy.
Why it’s essential to move beyond clinical trial information
If patients receiving treatment using prescription drugs are elderly or suffering from more than one chronic condition, it’s possible they would be deemed unsuitable to take part in a clinical trial.
Therefore, the increasing use of social media amongst pharmaceutical companies and patients is proving invaluable when assessing the true value and effect of medical product development.
Computers and other electronic tools used to gather and store huge amounts of health-related data have been increasing. And social media is now emerging as a platform for patients to share information about their experiences and effects from particular treatments.
Benefits from social pairing
To clarify, the FDA defines RWD as data collected from sources outside of traditional clinical trials and Real World Evidence (RWE) as the evidence derived from the aggregation and analysis of RWD elements. RWE links RWD with economic outcomes, demonstrates a product’s value proposition and is essential for market access (MA).
RWE brings many benefits, particularly when used alongside social media. In particular, it provides evidence that can be used to strengthen existing product claims or help develop new ones. But also, the following benefits have been realised:
- Comparatively, low cost compared with Randomised Controlled Trials
- Detailed analysis can be conducted effectively due to the ability to collect and store huge amounts of data
- Areas where conventional healthcare research is not possible or difficult can be studied and explored
- The data collection process is not governed by clinical trial regulations, offering greater control
Next steps in the process of understanding data
In a recent post on STATS, Julie C. Locklear, PharmD, MBA explains that RWD allows progression to the next critical step in the process: RWE. She further expands on what can be learned from the evidence. For example:
- What works for different patients, depending on their personal characteristics. E.g., Breast cancer treatments may function differently in different populations and focus should be on paying for what works, both in the right patient and at the right time.
- What happens over a patient’s lifetime, not just in one budget year?
- How to improve the quality of risk-sharing agreements between manufacturers and investors that are based on real-world outcomes.
Why is this happening now?
The increasing use of electronic tools to gather and store vast amounts of health-related data has opened the potential to view the bigger picture.
With more data available to learn from and compare, questions previously left unanswered, now have answers. Sophisticated software with analytical capabilities can apply results to improve future medical product development and approval.
Also, feedback not previously collected from patients during conventional trials, such as clinical and economic data reported by patient registries, claims databases, electronic health records, patient-reported outcomes, and literature reviews, can be learned through interaction on social media.
RWE is providing an effective way to link trials to reality using social media
The research learned from social media is becoming a powerful tool that is being used increasingly to answer research questions across numerous areas such as when drugs cause adverse reactions. It’s an easy way to connect the dots between patients and practitioners and also patients and their peers.
Advances in this area are helping to capture more information linked to the patient journey and more specifically the patients’ needs and their valuable feedback.
Although not exchanged in a clinical setting, the feedback can be invaluable for understanding how patients respond in real time. It can discover which candidates were excluded from clinical trials and why, and which patients are currently on specific treatments.
Areas for improvement
There are barriers to the effective use of this RWD. Dealing with text in social media settings can be challenging and time-consuming, for example. Different styles of communication, shorthand, typos, spelling mistakes, and contextual meaning all make analysis difficult.
Communication and support
Patients are now using web technologies such as social media to access and share opinions on diseases and treatments. It’s also effective as one of the few ways of contacting others with a rare disease or medical condition.
There are now specific forums for almost every disease and condition. They are used by patients to discuss and share records reaching back many years. Symptoms, treatments, and treatment options are often the main topic of conversation, along with summaries of entire treatment journeys with test histories and dates. This is an invaluable source of RWE. And as social media is already recognised as a platform to express opinions freely, patients are likely to be more honest.