Dermatology is experiencing a quiet revolution in how clinical evidence is generated and applied. For decades, randomised controlled trials (RCTs) have set the standard for evaluating treatments—but as the field evolves, real-world evidence (RWE) is stepping into the spotlight.
Unlike the tightly controlled environments of RCTs, RWE reflects the messiness and diversity of everyday clinical practice, offering insights into how treatments perform across broader populations and longer timeframes.
This shift is not about replacing traditional research but enhancing it—bringing nuance, context, and patient perspective into the decision-making process. In this article, we explore the growing role of RWE in dermatology, how it compares to RCTs, and what it means for clinicians aiming to deliver more informed, inclusive, and personalised care.
The Gold Standard: What Are Randomised Controlled Trials?
Randomised controlled trials (RCTs) have long been considered the gold standard in medical research. In dermatology, RCTs have provided the foundation for treatment guidelines, from topical corticosteroids to biologic therapies.
These trials are highly controlled, ensuring that results are statistically robust and free from bias. Participants are randomly assigned to treatment or placebo groups, which helps isolate the effects of the intervention. However, the strict inclusion criteria often exclude patients with comorbidities, multiple medications, or diverse ethnic backgrounds.
As a result, while RCTs offer internal validity, they may not always reflect the messier, more complex realities of clinical dermatology. Increasingly, questions are being raised about how applicable these findings are in day-to-day practice, especially when managing chronic, multifaceted conditions like eczema, psoriasis, and acne.
This has paved the way for real-world evidence (RWE) to enter the spotlight as a complementary form of research.
What Is Real-World Evidence in Dermatology?
Real-world evidence (RWE) refers to clinical data gathered outside the rigid structure of RCTs—typically from sources like electronic health records, insurance databases, patient registries, and observational cohort studies.
In dermatology, RWE captures how treatments perform in everyday settings: among diverse populations, with varying degrees of adherence, and in combination with other therapies. Unlike RCTs, which are expensive and time-consuming, RWE can be generated continuously and at scale.
For chronic skin conditions that require long-term management, such as hidradenitis suppurativa or atopic dermatitis, RWE offers insights into sustained efficacy, tolerability, and real-life usage patterns.
While less controlled, it provides a more nuanced understanding of how therapies work beyond the trial environment. Importantly, RWE can highlight patient-reported outcomes and experiences—elements often underrepresented in clinical trials but essential for informed decision-making in practice.
Comparing Study Populations: RCTs vs RWE
One of the most significant differences between RCTs and RWE lies in the study population. RCTs are highly selective—often excluding older adults, pregnant women, or those with multiple health conditions. This leads to a trial population that may not reflect the patients dermatologists see daily.
Real-world studies, by contrast, capture a broader cross-section of the population, including those with complex medical histories or socioeconomic challenges. For example, a biologic treatment for psoriasis may perform exceptionally well in an RCT but show a different safety or adherence profile when prescribed in a public healthcare setting.
In dermatology clinics, where patients range from teenagers with acne to elderly individuals with multiple comorbidities, RWE fills the gaps left by RCTs. By combining insights from both, clinicians can better assess treatment suitability for individuals, rather than relying solely on idealised trial data.
Speed and Accessibility of Research
RCTs are known for their lengthy timelines. From protocol development and ethical approval to recruitment and data analysis, a single trial can take several years to complete. In fast-moving fields like dermatology, where new treatments—especially biologics and targeted therapies—are rapidly emerging, this delay can hinder timely clinical adoption.
Real-world studies, in contrast, offer faster insights. Data from health records or patient registries can be analysed in real-time, allowing dermatologists to assess trends and make evidence-based decisions sooner.
During the COVID-19 pandemic, for instance, RWE played a vital role in understanding how patients with inflammatory skin diseases responded to infection and vaccination, at a time when RCTs were still in planning stages. This agility makes RWE an invaluable tool for bridging the gap between innovation and practical implementation in dermatology.
Drug Safety and Long-Term Monitoring
RCTs typically focus on short- to medium-term outcomes. While they can demonstrate a treatment’s efficacy and initial safety profile, they often fall short when it comes to long-term monitoring. This is particularly problematic in dermatology, where many conditions require lifelong treatment.
Real-world studies can track patients for extended periods, capturing late-onset side effects, changes in disease progression, and sustained efficacy. For example, long-term registry data on biologics in psoriasis patients have revealed insights into cardiovascular risk profiles and durability of response that RCTs could not address.
In this way, RWE supports pharmacovigilance and helps clinicians make informed decisions about ongoing care, balancing benefits and risks over the long haul. This continuous feedback loop enhances the real-world safety net for dermatological therapies.
Cost-Effectiveness and Resource Allocation
Healthcare budgets are increasingly stretched, making cost-effectiveness a key concern for dermatologists and policymakers alike. While RCTs can indicate if a treatment works, they often do not provide sufficient data on whether it offers value for money.
Real-world evidence can fill this gap by assessing health economics—how interventions perform in practice, considering actual adherence, dosage adjustments, and ancillary care. In dermatology, where biologics can cost thousands per patient annually, understanding cost-effectiveness is critical.
Studies using RWE have compared different psoriasis treatments across NHS settings, identifying those with lower relapse rates and reduced hospitalisations. These insights inform not just clinical decisions but also reimbursement and policy-making, making RWE a powerful ally in managing limited resources.
Personalised Medicine in Dermatology
Dermatology is moving towards personalised treatment approaches, particularly with the advent of genomic profiling and targeted therapies. However, RCTs, with their standardised protocols, struggle to accommodate personalised variables. Real-world data allows for stratification based on biomarkers, comorbidities, and lifestyle factors. This makes it easier to tailor treatments to individual patients.
For instance, RWE can identify which subpopulations respond best to specific biologics in atopic dermatitis, guiding dermatologists towards precision prescribing. It also enables adaptive treatment pathways—altering plans based on evolving patient needs.
By embracing RWE, dermatology can push closer to truly individualised care, aligning with broader trends in precision medicine.
Complementary, Not Competing: Using Both Approaches Together
The conversation is not about choosing between RCTs and RWE—but about using both to their fullest potential. Each approach has its strengths and limitations. RCTs remain indispensable for establishing initial efficacy and safety.
RWE, on the other hand, excels at contextualising these findings in real-world practice. Many regulatory bodies, including NICE and the FDA, now encourage the use of RWE to support RCT data during post-marketing surveillance or when expanding indications.
For dermatologists, integrating insights from both sources leads to better clinical decision-making—balancing scientific rigour with practical relevance. It’s a complementary relationship, not a contest, with patient outcomes being the ultimate beneficiary.
Case Study: Biologics for Psoriasis
Biologic treatments for moderate-to-severe psoriasis offer a clear example of how RCTs and RWE can work hand-in-hand. RCTs established the efficacy of drugs like secukinumab and ustekinumab, leading to their approval.
However, subsequent real-world studies revealed differences in adherence rates, injection site reactions, and comparative effectiveness across patient subtypes. For instance, registry data highlighted lower discontinuation rates in certain ethnic groups, prompting clinicians to revisit prescribing strategies.
These real-world insights also informed shared decision-making, as patients gained access to more realistic expectations of outcomes. Such combined data sets empower dermatologists to recommend treatments not just based on ideal conditions, but on lived experience.
Patient-Centred Outcomes and Satisfaction
RCTs tend to prioritise clinical endpoints like lesion clearance or PASI scores. While important, these do not always align with what matters most to patients—such as itch relief, sleep quality, or psychological wellbeing. RWE incorporates patient-reported outcomes more frequently, capturing satisfaction and quality of life improvements.
This holistic view is essential in dermatology, where the psychosocial impact of skin conditions is profound. For example, RWE studies in acne and rosacea often report improvements in self-esteem and social functioning—insights that may influence prescribing and support strategies.
Incorporating patient voice through RWE allows dermatologists to deliver care that truly aligns with individual needs and experiences.
Real-World Data and Health Inequalities
RCTs often fail to include underrepresented populations—ethnic minorities, rural patients, or those with lower socioeconomic status. RWE has the potential to spotlight these disparities by capturing data from broader healthcare settings.
In dermatology, this means identifying whether certain treatments are less effective or accessible to specific groups. For instance, RWE from community clinics may show higher non-adherence among patients facing language barriers or financial constraints.
These insights are crucial for addressing health inequalities and shaping inclusive care models. Dermatologists can use this data to adapt communication strategies, improve access, and advocate for systemic change.
Regulatory Shifts and RWE Integration
Regulatory authorities are increasingly recognising the value of RWE. The FDA and EMA have launched frameworks to incorporate real-world data into decision-making processes, especially for post-approval surveillance.
In dermatology, this is particularly relevant for drugs used long-term or off-label. RWE can support label expansions, identify rare side effects, and ensure that benefits persist in real-world use. This evolving regulatory landscape encourages dermatologists to contribute data and engage with registries.
It also creates opportunities for collaborative research and continuous quality improvement in clinical care.
The Role of Technology in Data Collection
Technological advancements—such as digital dermatology platforms, mobile apps, and wearable sensors—are revolutionising how RWE is collected. Patients can now log symptoms, upload skin images, and track treatment outcomes in real time. These tools enhance data accuracy and patient engagement.
In addition, artificial intelligence is being used to analyse vast real-world datasets, identifying patterns and predicting treatment responses. For dermatologists, this tech-driven RWE presents a new frontier in proactive, data-informed care.
It enables clinicians to monitor conditions more closely, adjust therapies dynamically, and involve patients as active participants in their treatment journey.
Challenges in Real-World Data Interpretation
Despite its advantages, RWE comes with challenges. Observational studies may be subject to bias, confounding variables, and incomplete data. Unlike RCTs, where control is built into the design, RWE relies on careful statistical adjustments and robust methodology to ensure validity.
Dermatologists need to be aware of these limitations and interpret findings with a critical eye. Training in evidence-based medicine must now include guidance on evaluating RWE, ensuring that clinicians can balance its insights with those of traditional trials. Understanding these nuances is key to responsibly incorporating RWE into practice.
Dermatology Registries: A Treasure Trove of RWE
One of the most powerful tools for generating real-world evidence in dermatology is the use of national and international patient registries. These databases collect long-term data from patients receiving treatment for chronic skin conditions like psoriasis, atopic dermatitis, and hidradenitis suppurativa.
Registries such as the British Association of Dermatologists Biologic Interventions Register (BADBIR) have been instrumental in assessing the long-term safety of biologics in routine practice. Unlike the narrow snapshots offered by RCTs, registries capture years of patient history, treatment switches, comorbidities, and lifestyle factors.
This ongoing accumulation of data not only supports clinical care but also feeds into policy-making and guideline development. For dermatologists, access to registry data means tapping into a collective intelligence of the field—learning from thousands of treatment journeys to inform better, more personalised patient care.
The Impact of RWE on Treatment Guidelines
As real-world evidence gains credibility, its role in shaping dermatological treatment guidelines is expanding. Historically, guidelines have relied predominantly on RCTs to rank the quality of evidence. However, organisations like NICE and the European Dermatology Forum are now incorporating RWE into their decision frameworks.
This is especially true in areas where RCTs are lacking or unfeasible—such as rare skin diseases or specific patient subgroups. Real-world studies have informed adjustments in stepwise treatment protocols, duration of therapy recommendations, and monitoring intervals. By including RWE, guidelines become more adaptable and relevant to clinical practice.
This shift empowers dermatologists to follow protocols that better align with patient diversity and real-life challenges, ultimately leading to more practical and effective care strategies.
Educating the Next Generation of Dermatologists
With the evidence landscape evolving, dermatology education must also adapt. Medical students and trainees are now being introduced not just to traditional trial methodology but also to the principles of real-world evidence, health informatics, and data interpretation.
Understanding how to evaluate observational studies, interpret registry data, and spot bias in non-randomised research is becoming a core skill. This shift ensures that the next generation of dermatologists is well-equipped to make evidence-based decisions in a more complex, data-rich environment.
Incorporating RWE into medical education also promotes a culture of critical thinking—encouraging future clinicians to question assumptions, explore broader sources of information, and engage with evidence that reflects the full spectrum of patient care.
Real-World Evidence in Rare and Understudied Skin Conditions
One of the greatest strengths of real-world evidence is its potential to shed light on rare or understudied dermatological conditions where RCTs are often not feasible. Diseases like epidermolysis bullosa, cutaneous lupus erythematosus, or dermatomyositis affect small, dispersed patient populations, making randomisation and control difficult.
Real-world studies—whether through multicentre collaborations, specialist registries, or patient-reported outcome platforms—can help fill this void. Observational insights into how treatments perform in these niche areas are invaluable for clinicians who otherwise must rely on anecdotal evidence or outdated guidance.
RWE allows for treatment patterns, adverse events, and patient satisfaction to be tracked meaningfully even when traditional trial infrastructure is unavailable. This ensures that care for patients with rare dermatological conditions continues to evolve alongside more common diseases.
Patient Engagement Through Real-World Data
The growing use of real-world data is also changing how patients engage with their dermatological care. With mobile apps, digital diaries, and symptom trackers, patients now play an active role in contributing to data that informs wider research. This shift towards participatory medicine fosters a stronger doctor–patient partnership.
Dermatologists can use this data not only to tailor care plans but also to encourage behavioural changes—like adherence to skincare routines or prompt reporting of flares. Furthermore, when patients see their lived experience reflected in published findings or treatment guidelines, it enhances trust and compliance.
The more inclusive and transparent the evidence base becomes, the more empowered patients feel in managing chronic skin conditions. This participatory approach is transforming evidence generation into a more collaborative and responsive process.
Bridging Gaps Between Primary and Specialist Care
In many healthcare systems, dermatology patients receive a mix of primary and specialist care. RCTs often focus on specialist-led interventions, overlooking how treatments are initiated and managed in GP settings. Real-world evidence offers a crucial bridge here, capturing data from general practice, community dermatology services, and non-specialist prescribers.
This helps identify gaps in care continuity, disparities in access, or inconsistent prescribing practices. For example, RWE might highlight that patients in rural areas face longer delays for specialist assessment or receive suboptimal treatment prior to referral.
Dermatologists can use this insight to guide outreach, develop shared care protocols, and improve equity in service delivery. By analysing how care is delivered across all touchpoints, RWE promotes a more integrated and patient-centred model.
Ethical Considerations in Real-World Research
As the use of real-world data expands, so too does the ethical complexity around its collection and use. Unlike RCTs, which operate under tightly controlled ethical frameworks and informed consent, RWE often involves data from routine care, where consent may be broad or implied. This raises questions about privacy, data ownership, and the risk of misuse.
Dermatology clinics must ensure they comply with data protection regulations like GDPR, especially when using electronic health records or image databases. Additionally, efforts should be made to anonymise data and include patients in conversations about how their information will be used.
Ethically sound real-world research requires transparency, robust governance, and sensitivity to patient autonomy. Dermatologists participating in or drawing from RWE studies must balance innovation with responsibility to maintain public trust.
Final Thoughts: A New Era of Evidence
The landscape of dermatological research is evolving. While randomised controlled trials remain the cornerstone of clinical evidence, real-world data is no longer a fringe player—it’s an essential companion.
Together, they offer a more complete picture of treatment effectiveness, safety, and patient experience. For dermatologists, this dual approach means better-informed decisions, more personalised care, and improved outcomes.
As we move forward, embracing both rigor and relevance will define the future of evidence-based dermatology.
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