Words by Isabel O’Brien
With data analytics enhancing opportunities to monitor drugs post-approval, the real-word evidence capabilities of medical affairs are growing. We look at how RWE can be used in conjunction with randomised control trials to influence healthcare decision-making.
Every drug has a childhood: a time to fail and grow within the safety of the lab. Developers act as their parents, investing time and money to give their creation the strongest chance for success. This relationship is synergistic and must be maintained once the drug flies the nest. A strong real-world evidence strategy led by medical affairs keeps the family connected, measuring if potential is being reached and identifying further areas for success.
“MA teams possess the scientific and clinical expertise required to design RWE studies that can support both healthcare internal and external research goals and deliver cross-functional value,” says Paul Berg, Senior Principal, Head of Real World Solutions, UK & Ireland, IQVIA.
Analytics tools enable fingers to remain on pulses: “A new era of big data and patient-driven healthcare is pushing the boundaries of RWE,” says Berg. Once restricted to conundrums such as: “Does my child perform better than yours?” to decode how competing drugs performed in similar patient populations, tools can now predict how a drug will perform in a novel situation, gauging its potential beyond previously tested uses.
“Today, MA organisations realise that generating RWE offers many benefits over the conduct of randomised controlled trials, and if done properly, RWE can be applied to healthcare decision-making,” says Scott Flanders, PhD, Vice President, Medical Affairs, Dendreon Pharmaceuticals LLC.
A new era of big data and patient-driven healthcare is pushing the boundaries of RWE
RWE allows MA to see how drugs perform beyond their childhood goals, which is particularly useful in the rare disease space, for reasons offered by Dr Maya Sharma, Global Medical Director, Modi-Mundipharma and Executive Board Member, ACMA Asia: “Because of the low patient pool, large scale and comparison studies are not possible, so a historical patient data pool has been used to extrapolate about efficacy of a new drug.”
This benefit is corroborated by Flanders, who raises the specific example of male breast cancer: “One recent high impact case involving RWE was the expansion of an approved indication of a targeted therapy known as a CDK 4/6 inhibitor.” The drug was conceived to treat female breast cancer, but RWE studies later showed it to be effective in male patients as well. Like a proud parent, the manufacturer presented these findings to the FDA in April 2019, offering “evidence from two Phase I safety studies, insurance claims data, and electronic health records,” says Flanders, which led to a new use case approval.
Recent research by McKinsey has shown that pharmaceutical companies that adopt RWE across their whole value chain could unlock up to $300 million in the next 3–5 years, including a $100 million cost saving if used to complement RCTs. RWE is far from a nice-to-have, it is an increasingly vital stipulation of the drug lifecycle, with Berg advising that “Focussing on key therapeutic areas where RWE can be a differentiator and provide strong return on investment,” will help to convince any sceptics of its necessity.
Generating RWE can be intricate and arduous work; therefore, MA teams must find ways to engage clinicians with their findings so as to ensure that new applications are known and are impacting healthcare decision-making. “To increase the understanding and communication of RWE, companies need to quickly expand their analytics capabilities ‘in house’ and hire medical writers who can turn data into peer-reviewed manuscripts,” advises Flanders. After all, what point is there in checking in on your children if not to include their successes in the family newsletter?
Drugs must excel in adulthood and given the time, money, and hopes that are pinned upon them, it makes sense to deploy strategies that ensure they are achieving, and even exceeding, their potential. RWE is not simply a monitoring tool; it is a growing and innovative extension of RCTs, with MA leading the way in using this framework to impact healthcare decision-making and benefit underserved patient populations.
As Sharma concludes: “MA, with their thorough understanding of science and analytics, can strategically communicate and convince internal stakeholders on better return on investment of RWE in terms of evidence generation showing better patient outcomes, leading to change in disease management guidelines, and wide acceptance of therapy by clinicians.”