How REAL is the significance of real-world data and electronic health records in healthcare?

Smart devices and wearables are the norm of the day. We wake up in the morning to our watch reminding us of the number of steps to walk, the speed of our heart beats etc. The same watch vibrates if we are stationary at our work station, prompting us to move. There is a surge in health-related data generated from mobiles, wearables, biosensors etc. with more than half of the world’s young and middle age population using one or more of these devices.

The world is dawning on a new era with organizations scrambling to make headway in using this real-time, real-world data to answer ‘perplexing questions in healthcare’, with the most daunting task being to store and use effectively this big data to benefit the society and innovate for a better tomorrow.

RWE and the pharma sector – Joining the dots

The 21st Century Cures Act, passed in December 2016, emphasizes the role of RWE in the healthcare sector. This act saliently recommends the use of data from in-silico methods (such as computer models and simulations) in clinical trials and further emboldens the use of previously undervalued data like demographics, biomarker/genomics data, patient-reported outcomes, survey data, and most importantly, RWE.

Benefits of RWE in the pharmaceutical sector:

Validity:
  • Assessing various treatments and dosages of drugs for a particular disease to select the best treatment combination for patients
  • Real-world evaluations help to arrive at the best therapeutic options with reduced economic burden
  • RWE is generated from a large number of patients in comparison to clinical trials and this sheer number closely resembles real-life situations and provides higher credibility in determining the use and efficacy of medications.
Directionality
  • RWE brings forth the best blend of demography and target populace for a particular clinical trial with information assembled by different methods
  • Clinical trials can be thus led with the best configurations of populations for better outcomes
Novelty
  • An approval for a new indication of an approved drug requires phase 2 and 3 clinical trials to establish safety and efficacy. However, with the new FDA guidelines that consider RWE as an important component; it is easier to attain approvals with data from physicians and clinical observations
  • New drug delivering devices and formulations also can be thus approved
Regulatory
  • It is vital to monitor, supervise and report adverse events for drugs licensed for a particular disease. A drug must be used by a large population to understand its long-term safety
  • A newly approved drug in the real world is used by physicians for a wide range of patients and conditions: different ethnicities, various disease comorbidities and a range of concomitant medications
  • This helps to gather efficient pharmacovigilance data to meet the requirements after approval and make regulatory decisions.

RWE involves the entire gamut of stakeholders – physicians, payers, policy makers, pharmaceutical and medical device manufacturers and suppliers – participating equally and responsibly in the decision-making process that impacts patients. The healthcare ecosystem is keeping a close watch on the proceedings considering the immense benefits in deploying RWE. The future looks rosy for the patient community because of the amount of real-world data that is churned globally. It is just left to the right people to make sense out of it.

Author:

Dr. Monali Misra

Senior Scientific Associate

The phamax RWE division provides supporting evidence for a broad range of therapeutic areas. The phamax chart review services are widely applied in many healthcare-based disciplines such as epidemiology, quality assessment, professional education and residency training, inpatient care and clinical research.

 

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