REAL WORLD EVIDENCE - A POTENTIAL TOOL IN CLINICAL RESEARCH

 REAL WORLD EVIDENCE - A POTENTIAL TOOL IN CLINICAL RESEARCH

 

       Clinical evidence of treatment in health care research can be obtained through a variety of studies, compiled into randomized controlled trials (RCTs) or observational studies. The computers and electronic devices have been used to collect and store large amounts of health-related data’s are extremely fast. Studies aimed at gathering evidence include the results of various trials (with direct or indirect comparisons) or, where possible, different types of evidence. This data has the potential to allow us to better build and conduct clinical trials and courses in the health care environment in order to answer questions in advance even though it may not be possible. 

 

 

 

       Moreover, with the development of adapted, modified and innovative new analytical capabilities, it has been widely acknowledged that in many new therapies, the current evidence of market approval is insufficient to fully guide physicians and policymakers' decisions to select the best treatment for patients in a standard clinical practice. Therefore, Proof of real world is required.

 

Real world data (RWD):

 

Real-world data is information about a patient's health status and / or the routine delivery of health care that is regularly collected within a clinical trial from a variety of sources.

 

Sources of RWD:

 

v  Electronic health records (EHRs) - The data of EHR’s provide the number of patients, significant signs and symptoms, and the results of laboratory images collected during clinical trial.

v  Claims and payment services - Billing and regulatory data comes from claims and government databases, and they provide information on the use of health services, population coverage, and descriptive patterns.

 

v  Product and disease registration - Registry information appears in the medical, device, patient, and specialized records. This information provides information on treatment outcomes, safety, and quality of patient health.

 

v  Patient-made data including home use settings - Patiently obtained data come from patient research, biometric clothing, and human health measures. This information provides direct information from the patient, and helps researchers understand what is going on without clinical visits. This information collected from the may inform on health status, such as cell phones.

 

In order to use real-world data to produce evidence, the data must be of adequate quality, consistency (are data values consistent with certain standards and formats), completeness (are data values available) and credibility (do the data values believe).

 

Real-World Evidence (RWE):

 

Real-world evidence refers to evidence based on the usage and risks and potential benefits of a drug product came from analysis of RWD which are collect on real world patients.

 

 

 

Figure: The journey from the data to the evidence. Real-world data (RWD) is data that is regularly collected in the form of electronic health records (EHRs), patient disease registration, dressings, genomic data sets, medical claims registration, and more. This information can be compiled, linked, and processed to produce important conclusions in the form of real-world evidence (RWE).

 

 

 

FDA uses RWE and RWD:

 

Ø  The first arises from the perspective of regulatory authorities, particularly with regard to post-market security monitoring and adverse events and regulatory decisions. 

 

Ø  Second, providers use RWE to support care decisions and to develop guidelines and tools that can help the treatment practice. 

 

Ø  Third, life science companies use data to support the development of clinical trials and observational studies to advance treatment options.

 

Need of RWE:

 

Ø  There is a gap between research and the day-to-day practice in health care, and it creates a gap between what is expected to happen and what actually happens.

 

Ø  But it is what really happens that matters. Driving measurable improvements in health care requires that we all focus on the realities that occur before, during, and after treatment procedures, interventions, and office visits.

 

Ø  RWE is here to fill those gaps and set us up for real. RWE comes into play when clinical trials cannot really account for the entire patient population of a particular disease. 

 

Ø  RWE provides answers to the medical problems and also to analyze effects of drugs over a longer period of time.

 

As a result, RWE is highly active and offers many benefits to the entire healthcare environment

 

Potential uses of RWE:

 

In order to know patient outcomes and to insure that patients get treatment that is right for them, real world data needs to be utilized. RWE is generated by analyzing data which is stored in electronic health records (EHR), medical claims or billing activities databases, registries, patient-generated data, mobile devices, etc. It may be derived.

 

Clinical Research(CR):

 

Ø  Most of the new therapies are conducted in conventional clinical trials, in which new drugs and equipment are developed and studied before they are marketed and widely distributed. Although clinical trials are incredibly important for the safety and efficacy of new technologies, they have their limitations (such as strict inclusion criteria, generalizability of clinical trial results across patient populations)

Ø  RWE can help overcome the limitations of trials by providing information about a broader community category. This can help physicians, researchers to better understand their products and how they work.

 

Ø  Also, during clinical trials, RWE may add traditional results measurements with patient-generated data such as patient-reported outcomes (PROs) or easyto-gather biometric data between physician appointments.

 

Ø  Clinical decision-making often depend on the level of risk / benefit of each patient. Although clinical uncertainty is not eliminated, RWE can help improve the quality of these tests and promote the most appropriate treatment for the patient and the tumor.

 

Post-Market Observation:

 

Ø  Once the approved product is marketed, Pharmaceutical Companies can use RWE for understand the safety associated with its products, efficiency, price, use of non-existent label and more. 

 

Ø  For example, we support multiple clinical data registrations that provide realtime RWE for device manufacturers who use to test their products, comparing new with existing options and level of care, and compliance with regulatory requirements.

 

Ø  Traditional phase IV and other marketing studies can be difficult and deal with a number of patient enrollment barriers such as changing custom patterns. Powerful RWE studies can produce different ideas for future basic science, drug development, health outcomes, and research.

 

Regulatory requirements:

 

RWE can help a company increase its product index profile. For example, while it may not be possible to perform a complete clinical trial of a product using non-label indicators, by collecting RWD for disease or product registration, companies may study the safety and details of their product or device results, which can be used to supplement referrals to US FDA or European Medicines Agency (EMA).

 

Regulatory decision-making:

 

Most of the science, drug development, patient access, and legal capacity go hand in hand with a focus on efforts to build a strong RWE for regulatory purposes. However, RCTs produce effective and safe efficacy in small patient communities, dismissed clinical settings, and a combination of limited medications. By expanding data sources, the RWE control level can provide the critical information needed by physicians, patients, and regulatory bodies to make informed decisions.

 

Drug development:

 

Ø  Newer oncology drugs and treatments deal with many areas of on-going decisions. Scientific and safety standards remain high. However, limited resources mean that some good drugs have not been fully tested. By identifying real-world unmet needs, RWE can assist in decision-making during early construction and guide clinical development strategies.

 

Ø  During drug development, RWE can also inform the development and testing of clinical trials. RWE about specific people can be used for removing unnecessarily restrictive exclusion criteria.

 

Ø  Understanding the patterns of availability of trial candidates (e.g., rare cancer that develops in chemotherapy) can make it possible to recruit the patients. Control weapons developed based on RWE are also being tested, especially cancer with re-established care level, poor prognosis, and low-grade diseases.

 

Conclusion:

 

     In conclusion, the importance and scope of possible RWE use cases require strict quality testing, especially if used making regulatory decisions. When analytics are performed using RWD, it is possible for health care companies to have a higher rate of success with better outcomes at almost every critical stage of product development. This, however, will require high-quality data, as well as overcoming challenges related to access and collaboration.

 

   Appropriately, RWE complements RCTs to help inform providers and patients of outcomes and safety concerns that may not have been identified or studied during the trials. Cost of care, utilization of resources, and certain outcomes reported by patients not in RCTs but common in RWE studies.

 

   Global health research networks improve clinical research and availability by providing an RWD exchange platform integrated with AI and analytics in health research and clinical settings. There is also a step towards integrated networks to set up their own data analysis platforms to provide RWD access to relevant stakeholders, including the processes and tools needed to manage patient privacy and consent.

 By,

Karthikeyan A Industrial Biotechnology Student at Clinosol.