Real World Evidence Disease Specific Study
RWE Study
Real World Evidence
Spade Health RWE transforms real-world data into useful insights that can help direct the product development cycle by utilising cutting-edge quantitative techniques. We are able to make sure that our clients are well-prepared for regulatory submissions and successful at tapping into new markets thanks to our experience and wide network of partners.
Spade Health RWE experts offer data-driven insights that put your product in the hands of the patients who need it the most. These insights range from epidemiology, treatment patterns, and HCRU/cost studies to treatment adherence and persistence, patient preference, and post-approval safety studies.
We distinguish ourselves through our unrivalled knowledge of advanced analytics, robust methods, and strategic research innovation. We balance scientific rigour with commercial awareness to provide you with the evidence you need to launch new products, overcome regulatory hurdles, and achieve payer approval, with expertise harnessing the power of data across a diverse range of international geographies.
What is Real World Data?
The IMA defines it as “ the data relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources ”.
This definition is a broad scope of data collection, with the core focus of Real Word Data being to measure and better understand healthcare data collected under real-life practice circumstances through the perspective of healthcare professionals and sometimes the patients themselves.
Sources include operational studies designed to garnish information on patients, and existing patient records, with product and disease registries.
1. Clinical information from case report forms and electronic health records (EHRs) (eCRFs) The patient’s demographics, family history, comorbidities, history of procedures and treatments, and results are all provided by these data.
2. Information provided by patients through patient-reported outcome (PRO) surveys These data give researchers firsthand patient perspectives and aid in their understanding of events that go on outside of appointments, procedures, and hospital stays.
3. Cost and usage information collected from public datasets and claims They offer data on population coverage, prescription patterns, and the use of healthcare services.
4. Information on public health from different government data sources These provide important new data that stakeholders can use to better meet the needs of the populations they serve.
This Process Includes Several Steps:
- Establishing a study protocol that addresses pertinent clinical queries.
- Outlining which RWD sources allow for the collection of which data elements.
- Setting up agreements and protocols for data collection with RWD sources that are already in place.
- Using probabilistic record matching algorithms to combine various data sources.
- Using editable eCRFs to validate and supplement blended data
- Defining and computing outcomes and measures that is clinically pertinent.
- Correctly evaluating and adjusting for variations in data availability, quality, and patient confounding factors affecting measured outcomes.
Real-World Evidence in Healthcare
Welcome to the cutting edge of healthcare evolution at Spade Research, where Real-World Evidence (RWE) emerges as a powerful catalyst for informed decision-making, research advancements, and transformative healthcare practices. As we navigate the intricate tapestry of patient experiences, treatment outcomes, and healthcare utilization, our commitment is to unravel the insights embedded in real-world data to shape a future where healthcare is not only evidence-based but also patient-centric.
Unveiling Real-World Insights
At Spade Research, we recognize that the true essence of healthcare lies in the diverse experiences of individuals navigating their health journeys. Our data-driven approach transforms conventional research paradigms, revealing patterns and outcomes that might be overlooked in controlled environments.
Comprehensive RWE Solutions
Discover the power of our comprehensive RWE solutions, meticulously designed to meet the evolving needs of healthcare stakeholders. From pharmaceutical companies seeking post-market insights to healthcare providers aiming to optimize patient care pathways, our RWE offerings span the spectrum.
Patient-Centric Healthcare Transformation
At the heart of our Real-World Evidence endeavours is a commitment to patient-centric care. By understanding the real-world impacts of treatments, interventions, and healthcare policies, we contribute to a healthcare landscape that is not only evidence-driven but also deeply attuned to the needs and experiences of the individuals it serves.
Experience the Spade Research Difference
Embrace the transformative power of Real-World Evidence with Spade Research. Explore our services, engage with our team, and let’s embark on a journey to redefine healthcare through the lens of real-world insights.
Real-World Evidence For Pharmaceutical and Medical Device Companies
Spade Health RWE transforms real-world data into useful insights that can help direct the product development cycle by utilising cutting-edge quantitative techniques.
Our Capabilities In Disease Specific Study
We collect real-world evidence based only on data collected from patients in hospitals and clinics.
With access to more than 600K+including 20+ physician specialists, 100,000+ other healthcare professionals and over 300,000+ patients and caregivers.
We would let you know our understanding of patient life and the impact of disease outside of the clinical context.
We can help you get ethics committee approvals from other government health bodies so that the study runs smoothly.
Case Studies
Objective:
Deliver clinical understanding of a wide range of therapy areas through data collection from active physicians and patients.
Challenges:
- Physician tends to reject participating study without EC and health departments approvals
- Different regulations and lot of paper work
- Completing patient record forms can be tedious, so may limit participation.
- Logistical involvement may cause additional overheads. This may cause an increase in the cost of operations, we are very competitive in terms of cost and very transparent to our client in every steps of the study
- Patients, Doctors, Other HCPs are compensated for their time and PRF completion
Therapeutic Area of Interest
Psoriasis
Rheumatic Patients
Haematology Diseases
Methodology
MDs/Derma – 15 minute F2F survey and 20 Patient Record Forms (PRF
25 minute online survey Patients – PRF 15 minute online survey
Market Mix
Dermatologists, GPs, IMs India, BGD, Nepal
Rheumatologists, Infectious disease specialists UK and USA
Haemato Onco in USA, IN
Sample Size
N=100 per European market
N=100 IN market N=50 PAK market MDs Completes =750Patient Completes =2250
N=50 Haematologists per market Patient Completes = 200
Role in Shaping RWE Study in India
Welcome to Spade Research, where innovation meets impact in shaping Real-World Evidence (RWE) studies in India. As pioneers in the field, we take pride in our contributions to the dynamic landscape of RWE studies, playing a pivotal role in advancing research methodologies and outcomes. Our dedicated team, armed with expertise and commitment, collaborates seamlessly to redefine the boundaries of real-world evidence. Explore how Spade Research is not just a participant but a catalyst in shaping the narrative of RWE studies in India, unlocking new insights and shaping the future of evidence-based healthcare.
With us, you can get data-driven insights for your products and commercial awareness about the product before launching it in the market. We use advanced quantitative techniques to assist during product development cycle for successfully entering new products into the markets.
Join us on this journey of discovery and transformation at the forefront of real-world evidence research.
Uses of Real-World Evidence in Pharmaceutical and Device Companies
RWE is widely used by the pharmaceutical and medical device industries because it can add value throughout the entire product lifecycle.
Topic #1: Research in the Life Sciences and RWE (Pre-Trial Design)
RWE is crucial to research throughout the entire product lifecycle for both device and pharmaceutical companies. By assisting researchers in locating potential patients and developing appropriate inclusion standards for clinical trials, it can influence pre-trial study design.
Topic #2: RWE and Clinical Studies and Trials
Traditional clinical trials, where new drugs and devices are meticulously examined and tracked before they can be sold and widely dispersed, are a major contributor to medical innovation. Clinical trials have some limitations when compared to other forms of evidence, despite their importance in determining the safety and effectiveness of new technologies.
Topic #3: RWE and Post-Market Surveillance
RWE can assist a pharmaceutical or medical device company in understanding their products’ relative safety, effectiveness, value, off-label use, and other factors after a product has been approved and marketed. Healthcare stakeholders benefit from this post-market surveillance, also known as post-marketing surveillance. For instance, we provide support for a number of clinical data registries that offer real-time RWE for device manufacturers to assess their goods.
Topic #4: RWE and Regulatory Requirements
RWE can assist businesses in broadening a product’s indication profile. For instance, while it might not be possible to conduct a full clinical trial for a product that is frequently used for off-label indications, companies may be able to study safety and outcomes data for their product or device by collecting RWD from disease or product registries, which can then be used to supplement a submission to the U.S. FDA or European Medicines Agency (EMA).
Why Choose Spade Health RWE?
The Spade Health RWE team takes pride in offering specialized, adaptable, and purpose-specific solutions that are centered on the requirements of our clients. We still have the adaptability and dedication you would anticipate from a much smaller business.
Our database network offers exclusive access to data from around the world, making multi-country studies possible. We are uniquely qualified to design and carry out database studies as well as other RWE studies like surveys and/or reviews of medical charts. All of our RWE studies are based on a variety of analytical techniques, including latent class analyses in DCE studies, time to event endpoints and difference in difference analyses, advanced matching techniques, and synthetic control group comparisons.