Unlocking the Potential of Real-World Evidence
How PhD Graduates Can Make an Impact
As the treatment approach for genetic disorders shifts towards targeted therapies, drug development has also shifted towards advancing precision medicine for specific patient populations. This means that many drugs under development are becoming more tailored to the particular genetic mutations of the patient population. The use of precision medicine allows for more effective treatment with fewer side effects.
At the same time, the rapid growth of computing technology, the advancement of machine learning algorithms, and the widespread availability of electronic health data have enabled real-world evidence to play a vital role in supporting drug development and regulatory decision-making. Electronic health data can be collected from a variety of sources, such as electronic medical records, wearable devices, and health registers, and can be used to identify e.g., patterns and trends in patient treatment and patient outcomes.
For this article, we had the privilege of hosting a webinar with Tina Jacob, a former PhD student at Karolinska Institute in Sweden. She discussed the significance of real-world evidence (RWE) professionals in the life sciences industry and the growing need for their skills. Additionally, she shared her journey into becoming an RWE consultant, elaborated on her daily responsibilities, and how she applies her PhD skills in her current role.
What is Real-World Evidence?
Real-world evidence (RWE) is a field that has gained popularity in recent years but focuses on what epidemiologists have done for a long time. However, with the increasing availability of large-scale healthcare data, RWE has become an important tool for generating evidence that is more reflective of real-world patient outcomes.
Real-world evidence is based on real-world data, i.e., data that is collected in routine healthcare, outside the context of clinical trials, and thus reflects how patients are treated in clinical practice. Potential data sources include health registries, medical records kept at the hospitals, and claims databases from insurance companies. Based on this data, evidence can be generated that can be used for drug development and approval, reimbursement applications, and post-marketing surveillance. RWE can also be valuable in guiding clinical decision-making.
Common research that can be explored with real-world evidence are for example:
Which subpopulations of patients diagnosed with a specific disease have the worst outcomes? Identifying these patients may help to specifically target those who are not responding well to current treatments.
Which treatments do patients with a certain diagnosis receive in clinical practice? This information is important when identifying suitable comparators for a new drug.
Companies that offer RWE services usually provide full support for the entire research process, from defining research questions to running data analyses and generating study reports or manuscripts. RWE companies also help to identify suitable data sources, to engage clinicians and other stakeholders, and to navigate the administrative and ethical requirements for using healthcare data for research purposes.
What Does a Day in the Life of an RWE Consultant Look Like?
Working as a scientist in RWE consulting involves working on multiple projects at once, with project load increasing as the consultant becomes more experienced. One important aspect of the work is interacting with clinicians in different therapeutic areas as part of scientific collaborations to obtain clinical insights that are crucial to design clinically meaningful studies and interpret the results. In addition, consultants might also conduct market research, including formal, paid interviews with doctors.
However, the day-to-day work of an RWE consultant is not just about meetings and collaborations. A significant proportion of the time is also dedicated to knowledge generation via desk research and data analysis. Notably, the ability to communicate results via concise data-driven client reports and productive client meetings is almost as important as the results themselves.
In conclusion, life as an RWE consultant is a dynamic and engaging role that involves a range of project types, a mix of desk work and meetings, as well as close collaboration with healthcare professionals and clients. While knowledge generation and data analysis are key aspects of the job, successful consultants need to be able to prepare concise reports, conduct productive meetings, and work closely with clinicians to create meaningful insights.
Real-World Evidence Consulting: The Good and the Bad
One of the main highlights of being an RWE consultant is the diversity of tasks/projects and the excitement that this provides. Working on various projects covering different diseases allows RWE professionals to constantly learn and expand their knowledge. Moreover, smaller companies can offer unique opportunities for growth and learning, by engaging employees in all steps required for a real-world study (from initial feasibility assessments, to establishing collaborations, hands-on data analysis, and scientific communication).
Depending on the company, consulting work may also offer significant freedom around working hours. Although client and clinician meetings must be attended, there is usually a lot of flexibility in the schedule, allowing e.g., for work to be done in the morning, picking up children, and working again in the evening. Additionally, many companies are embracing hybrid work styles that allow employees to work from home or the office, whichever they prefer.
Another benefit of working in industry in general are growth opportunities. While in academia, it is possible to learn and do a lot, it is usually not officially recognized. In industry, however, there is recognition for development and growth, leading to adjusted job titles, increased salary, and more leadership opportunities.
However, working in the consulting industry also has its challenges. High pace comes with frequent deadlines and little downtime. Projects are shaped by what the customers want/need rather than personal scientific interest. It is important to be able to accept working in this setting, where there is less self-determination. Sometimes, interesting aspects of projects have to be left unexplored, as once a report is delivered, there is no incentive to keep working on it.
Overall, working in the consulting industry can provide great learning experiences and opportunities for growth, but it also requires flexibility and the ability to work under pressure. It is important to carefully weigh the benefits and challenges when deciding whether to transition to the consulting industry.
How Real-World Evidence and Medical Affairs Complement Each
RWE refers to evidence generated based on data from real-world data sources. This data can be used to generate evidence on the safety and effectiveness of medical interventions. Medical Affairs, on the other hand, is about medical professionals or disease experts giving evidence-based advice on the use of medical interventions.
“Collaboration between medical affairs and RWE is key to support pharma companies in providing advisory services”
Thus, generating RWE for the drugs that Medical Affairs teams work with is crucial. Although time-consuming, generation of RWE is often required by external authorities to provide evidence on the efficacy of the drugs. Therefore, collaboration between Medical Affairs and RWE is key to support pharma companies in generating the evidence needed to support the use a specific drug. The teams usually complement each other well with their in-depth therapeutic area knowledge (Medical Affairs team) and knowledge of real-world data sources and what analyses are feasible (RWE team).
The Value of a PhD: Transferable Skills
Many people pursue a PhD in order to become experts in their respective fields. However, after years of hard work and dedication, the question arises: what next? While some may choose to pursue an academic career, others may decide to transition into industry. Whether you decide to transition to industry or not, there is great value of the transferable skills that a PhD equips you with.
One of the most valuable aspects of a PhD or postdoc is the ability to process complex scientific information and build evidence. Researchers are trained to critically analyze and compile information, which can be applied to any life science-related topic. Moreover, academics have the ability to communicate their science to different audiences, from disease experts to the general public.
Furthermore, a PhD project requires candidates to take on the responsibility of being project managers, motivating themselves, finding collaborators, and pushing through even when the task seems impossible. Resilience and determination are skills that can serve PhD graduates well in any future role.
In conclusion, while a PhD is often seen as a path towards an academic career, it provides candidates with a wide range of transferable skills that can be applied to a variety of fields, including real-world evidence. For those looking to transition into industry, the ability to understand complex scientific information, communicate effectively, and manage projects is highly valuable. With these skills, PhD graduates are well-equipped to succeed in the real world.
In conclusion, PhD graduates have a lot to offer for work in the field of real-world evidence. While specific disease knowledge may be important e.g., for medical affairs roles, it is mostly the transferable skills that equip PhD graduates for work in the real-world evidence field. Moreover, resilience and determination can prove invaluable in navigating the challenges of the working world. As such, PhD graduates should not overlook the potential opportunities available in the realm of real-world evidence and should instead recognize that their skillset as highly valuable in this field.
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/Beyond Academia