Why pharma craves real-world data

by Ales Tichopad | Feb 16, 2016

The pharmaceutical business encompasses many different activities, many of which are not directly in the public eye. Perhaps this is why pharmaceutical companies are often the subjects of conspiracy theories. On one hand, pharma may resemble a sworn society enclosed within sterile labs. On the other hand, in an effort to secure revenues, it stretches its feelers and undertakes various ventures to understand the habits and needs of real physicians and patients that may – in reality – contrast sharply to so-called "rational" scientific opinions. This is all to ensure that the few candidate molecules that actually become fully registered and approved medicines will be able to survive the needs and expectations of the real-world and generate revenue. A significant part of this revenue can then be reinvested in the pipeline to fuel ongoing R&D and product development and – as in other businesses – marketing.

It is a well acknowledged fact that only a tiny percent of promising molecules become safe and effective medicine despite years of effort and hundreds of million Euro in costs. It is understandable then why the sales expectation on new launches is so high. Even equipped with good scientific evidence on safety and efficacy from clinical trials, new drugs are still far from guaranteed to generate a positive return on investment. Therefore, companies have realized that overcoming market-entry hurdles, gaining reimbursement and ensuring their products will be available to a large potential patient population is the key to securing sustainable profitability. To accomplish these goals, companies must first gain a deep understanding of epidemiology, patient needs and behavior, physicians’ habits, competitive products, as well as establishing the right ratio between medicine price and its benefit. To become a market leader, modern medicines must be able to largely replace existing treatments with superior effectiveness, safety or comfort for the patient.

Although it may seem reasonable to expect that new medicines that have been extensively tested in clinical trials and have been demonstrated to satisfy the high expectations of patients, healthcare professionals and regulators will succeed, use in the real world can sometimes prove a somewhat sobering experience. Real-world results can and do differ to the results observed in clinical trials.

In a clinical trial, drugs are often tested on carefully selected patients, having been administered by well trained and motivated doctors in well-defined and controlled conditions. In reality, there could be all kinds of barriers that stop a product from reaching its full biological potential. The most common issues we have observed in our numerous real-world studies are patient failure to follow their doctor's dosage instructions, inappropriate combinations with other medication or alcohol or even inappropriate prescribing or dosage by physicians. Often, a promising drug with outstanding clinical evidence of efficacy may in the real world show rather poor outcomes if it is avoided by patients due to unpleasant side effects regardless of the potential benefit. Often side effects may not even be experienced by the patient, yet a fear often based on myths and rumor can lead to rejection.

In developed countries where modern costly medication plays an increasingly important role in healthcare, state regulators pay close attention to the economic benefits to be derived from new drugs entering markets. Will a new drug funded by insurers or national health funds deliver tangible benefits to the patient and society by avoiding hospitalizations for example, or perhaps enforced early retirement in severely diseased patients? The multidisciplinary field of health economics has since 2005 become a critical part of healthcare policy, and the request for scientifically sound analyses is increasing. In the absence of high-quality real-world data any such analysis would be just as informative as crystal ball reading.

To assemble the valuable information about how a particular drug matches real-world needs and satisfies regulators, physicians and patients, data must be collected and analyzed. Such data – as long as it has been collected in accordance with strict scientific methodology and ethics – should be seen as a critical and important contributor to modern medicine as it provides important information that will lead to the optimal use of medication. Of course, it also helps pharma understand the market potential for its products as well by understanding doctor prescribing habits, patient preferences and competitive medications! Still, as long as marketing continues to focus on delivering incremental benefits to patients and society, the use of real-world data can be justified commercially.

CEEOR, now a part of Kantar Health, is committed to conduct all its research ethically and scientifically. Over the years and working with more than 10,000 physicians, we have realized that a physician who provides us with data is our most important research partner. Therefore, just as we would never compromise our scientific and ethical principles we would equally never approach our research partners requesting data without properly compensating them for their work. Only in this way can we ensure that our data is of the highest quality and our research is contributing to an improvement in healthcare.

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