RWE – For better accessibility of drug treatments
Thinking Beyond the Clinical trials
Though clinical trials are the gold standard measuring the safety and efficacy of drugs, to evaluate the cost-efficiency of a drug in a real-world environment and measure its impact on quality of healthcare, RCTs need to be supplemented or followed up with the comparatively new standard, called real-world evidence (RWE).
Real world evidence has is entering every part of the drug product life cycle from discovery to the late stage marketing.
RWE The Basics
RCT RWE
Patients are randomised into the study treatment; Selection of the treatment choice does not depend on physician and patient Treatment of choice depends on choice of the treating doctor according …show more content…
Patient adherence study:
Adherence to drug therapy is important as non-adherence results in lower effectiveness of the therapy to patients and increased costs to payers and regulator. After analysing the causes for non-compliance using available real-world data, patients can be formed into groups to design a targeted educational program. If the cause of non-adherence is drug design as suggested by data analytics, new drug or treatment design can be initiated.
Outcome-based pricing/contract:
Pharma companies can provide evidence of their product efficacy based on the real-world data to insurance payers. Insurance payers can develop their own treatment guideline based on the evidence provided to tackle the increasing healthcare costs.
In clinical research:
Formulate better hypothesis to be tested; identify investigator, sites for clinical trials based on patient availability. It can suggest the feasibility of the clinical trial; it can also suggest if the conditions represent the real-world conditions of the target population.
In product life …show more content…
The longitudinal observational study will collect, organize and analyze broad phenotypic health data from 10,000 participants over the course of four years, establishing a well-defined baseline of good health.
Conclusions
As more drugs are being approved through accelerated pathways, it is crucial that the FDA receives the best quality evidence. No doubt that clinical research is the gold standard evidence, RWD can be used effectively to supplement this data in clinical practice. By using the RWE researchers can improve the clinical trial design to get the optimum results, it helps insurance payers to develop their own treatment guidelines and it guides manufacturers in framing the marketing policies and fixing the price of drugs.
Research in the real world is not only offering a more generalizable solution but also a much less expensive solution. Advanced analytical and cognitive technologies are providing fast, high-quality and well-curated data to speed discovery and time to market, moving us closer to personalized, outcomes-based
Thinking Beyond the Clinical trials
Though clinical trials are the gold standard measuring the safety and efficacy of drugs, to evaluate the cost-efficiency of a drug in a real-world environment and measure its impact on quality of healthcare, RCTs need to be supplemented or followed up with the comparatively new standard, called real-world evidence (RWE).
Real world evidence has is entering every part of the drug product life cycle from discovery to the late stage marketing.
RWE The Basics
RCT RWE
Patients are randomised into the study treatment; Selection of the treatment choice does not depend on physician and patient Treatment of choice depends on choice of the treating doctor according …show more content…
Patient adherence study:
Adherence to drug therapy is important as non-adherence results in lower effectiveness of the therapy to patients and increased costs to payers and regulator. After analysing the causes for non-compliance using available real-world data, patients can be formed into groups to design a targeted educational program. If the cause of non-adherence is drug design as suggested by data analytics, new drug or treatment design can be initiated.
Outcome-based pricing/contract:
Pharma companies can provide evidence of their product efficacy based on the real-world data to insurance payers. Insurance payers can develop their own treatment guideline based on the evidence provided to tackle the increasing healthcare costs.
In clinical research:
Formulate better hypothesis to be tested; identify investigator, sites for clinical trials based on patient availability. It can suggest the feasibility of the clinical trial; it can also suggest if the conditions represent the real-world conditions of the target population.
In product life …show more content…
The longitudinal observational study will collect, organize and analyze broad phenotypic health data from 10,000 participants over the course of four years, establishing a well-defined baseline of good health.
Conclusions
As more drugs are being approved through accelerated pathways, it is crucial that the FDA receives the best quality evidence. No doubt that clinical research is the gold standard evidence, RWD can be used effectively to supplement this data in clinical practice. By using the RWE researchers can improve the clinical trial design to get the optimum results, it helps insurance payers to develop their own treatment guidelines and it guides manufacturers in framing the marketing policies and fixing the price of drugs.
Research in the real world is not only offering a more generalizable solution but also a much less expensive solution. Advanced analytical and cognitive technologies are providing fast, high-quality and well-curated data to speed discovery and time to market, moving us closer to personalized, outcomes-based