The research fraternity has termed the use of patient outcomes data in medical evidence for many years. But, the idea of Real World Evidence is a more recent phenomenon.
Real World Evidence is generally referred to as the key conclusions, analyses, evaluations derived from varied sources of data collected from RCTs, patient registries, publications etc. Hence, it involves real world data which resources at increasing population levels to generate meaningful insights to provide better healthcare decisions.
The conclusions in the real-world set-up studies are derived from data associated with outcomes from real-world practice settings. The data relevant to RWE comes in multiple types and forms. For example:
– Clinical Trials Data is derived from the outcomes of randomized clinical trials
– Clinical Setting Data is derived from patient medical records and patient care
– Pharmacy Data is derived from prescription orders and fulfillment
– Claims Data is derived from insurance reimbursements
The essential part of healthcare involves the ability to collect and capture data so it can be further allocated for appropriate distribution and utilized by all stakeholders.
This gives light to the important resource which is being shadowed, and that is patients. Observational studies and non-interventional studies have a huge target population and broader timelines. On the course, majority of the data sets are often missed to be collected or documented.
The systems used to analyze data and the way in which studies are released differ depending on how the data is utilized in the long run from a gamut of data sets. Hence, if the data is derived directly from the patient experience, it can give an extra edge and facilitate to yield better data. There is a huge scope in creating direct-to-patient engagement strategies which can help to develop specific treatment approaches, give a better picture to understand certain medical history and diagnosis for specific therapeutics, give visibility in safety reporting and eventually support pharma companies in regulatory dossier submission.
To overcome certain limitations revolving around evidence-base studies, the following key tips on the study design should be considered by pharmaceutical companies:
1. Educate – Increase the importance of data collection
– Train physicians/nurses/para-medical staff and certain academic centers to gather basic data
– Generate programs for patients on why the data is collected and how it will benefit research
– Simplify inclusion criteria and data collection sets for observational studies
– Prioritize objectives, endpoints for clear data analysis
2. Enhance – Focus on the required data, data analyses for reliable RWE
– Develop tools for reasonable decision-making of outcome data by real-time or active analysis
– Boost patient-powered registries with integrated data solutions
– Network with regulators for regulatory clarifications and understanding
3. Engage – Balance on-site and patient burden
– Create patient-based forums for better involvement and awareness during an ongoing study
– Retention strategy plans for minimum lost to follow-up, withdrawal of patients on a regular basis
– Optimize the global reach with the network of the regulators, SMEs, patients with technology and automation
The potential of RWE is that a rich diversity of data collected from extremely large samples of patients will yield more precise, well-targeted and effective healthcare at the individual patient level. After all, any data in the RWE set-up originates from patients, and ultimately the same patients become the recipients of better healthcare.
We know that Real World Evidence is here to stay and will gradually increase the opportunity for other markets, too. By assessing the three E’s (Educate, Enhance and Engage), we can carve a niche by focusing on direct-to-patient data collection in real-world evidence study set-ups and also create pathways which will bridge the gap between the key players, namely, patients, pharma companies and regulatory authorities.