Medical history form with a stethoscope and pen

Real World Evidence

The Future of Data Generation: Role of an Evidenced-Based Study

February 22nd, 2017 - 0 Comments

Recently, I got a chance to talk to a renowned physician who is also the author of numerous publications. I asked him about his view on the future of data generation.  He feels that the way technology is advancing, the nature of data generation will change on an everyday basis.

At present various methods exist for data collection in research (including the healthcare industry). Clinical trials are very popular in the data collection niche even though they have limitations. They often restrict the population of patients “allowed to enter” the study. Often, those who are really difficult / complicated are excluded. It has been recognized and appreciated that randomized clinical trial (RCT) is the highest available level of evidence to prove or disprove a hypothesis. However, the hypothesis may be wrong due to various reasons. The physician says “I have several experiences to prove that ‘badly’ done RCTs may do a lot of potential harm”. He cited one example from his personal experience: a recently published study on Haemophilia with certain methodological issues, that raised more questions and doubts than provided answers. In principle, he explained that if the confounder/mistake is present (for whatever reason) in most of the subjects under both arms, even the randomization will not help, nor will the multivariate analysis. He does not mean that we should not do RCTs, but he specified that with the help of Real World Evidence (RWE) we can overcome and/or counterbalance these weaknesses and vice versa. He says “RWEs are and will be valuable sources of data for both clinical work and science. RWE simply shall belong (as one of many pieces) into the mosaic of our knowledge”.

Data exists in multiple forms – published, unpublished and most importantly the personal experience of Health Care Practitioners (HCPs), care givers and patients. With the advent of technology, it is increasingly going to be a merger of conventional and disruptive ways of gathering data to generate evidence. Progressively, evidence-based studies are securing a position in the data collection niche. In spite of the challenges to establish the best practices in RWE programs, Real World Evidence has the potential to both escalate adeptness in research and development, and to bridge the gap between the proof of appropriateness required to pass regulatory scrutiny and the demonstration of likely effectiveness needed to cater to the needs of health technology assessment bodies. Patients and caregivers are getting the freedom to track and report their health status as well as outcomes with the evolution of technology.

For example, to compare a new intervention looking at retrospective data for existing molecules, data is collected prospectively for the new molecule, assessing the real-life experience of HCPs, care givers and based on tracking devices and self-monitoring tools, information is gathered from patients on their outcomes. This adds a layer of real-time tracking and perspectives of the relevant stakeholders for the scientifically gathered information. This is already ushering the new RWE in developed countries. Fast-tracking evidence-based studies will focus on patient outcomes and position this as a mainstream research.

Physicians are confident now and foresee a day when their patients would participate not just in data generation, but also in treatment decisions or even recommend their own treatments. The day is closer than we believed. This is already happening in developed countries, but the real value will be seen in resource constrained emerging economies, where technology is omnipresent, but not healthcare access.


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