Information technology in the evaluation of RWD / RWE (Real-World Data / Real-World Evidence)

2021 ◽  
Author(s):  
OV Zhukova ◽  
AL Khokholov
Keyword(s):  
Health Care ◽  
Information Technology ◽  
Clinical Practice ◽  
Clinical Efficacy ◽  
Real World ◽  
Information Technologies ◽  
Real World Data ◽  
Real World Evidence ◽  
Software Modules ◽  
Real Clinical Practice

The features of evaluating data from real clinical practice are discussed. Approaches to material processing for decision support in medicine and health care are also given. The development of standardized methods of analysis with the possibility of obtaining a unified indicator for assessing data from routine clinical practice, combined with the development of information technology is the direction of development of the concept of result-oriented health care. The classification of information technologies used in medicine and public health is presented. The main characteristics and functioning features of the developed software modules for automated data evaluation of real clinical practice are presented: a program for the distribution of drugs on the levels of clinical efficacy, a program to assess the effectiveness of therapy for the specified period; a program to determine the interval of clinical efficacy of drugs.

scholarly journals Valuing new medicines in the early 21:st century

2017 ◽  
Vol 5 (1) ◽  
pp. 7-22
Author(s):  
Katarina Steen Carlsson ◽  
Bengt Jönsson
Keyword(s):  
Health Care ◽  
Clinical Practice ◽  
Real World ◽  
Patent Protection ◽  
New Technologies ◽  
New Technology ◽  
Treatment Strategies ◽  
Real World Data ◽  
Study Results ◽  
Pricing And Reimbursement

What is the actual value of new medicines? The answer to this question is the key to rational use of new technologies in health care and for design of appropriate incentives for innovation. In this paper we present methods, data and study results for valuing new medical technologies in a life cycle perspective, relevant for development of a new approach to contract and payment for innovation that can replace present systems for pricing and reimbursement.   Focus is on value in clinical practice, and on the data needs and methods needed for the development of outcome-based payment systems that balances risks and rewards for innovation in health care. We provide an overview of studies from the Swedish context on the value of new medicines introduced in the treatment of diabetes, cancer, cardiovascular disease and rheumatoid arthritis. These studies using national health data and quality registers emphasise the importance of continuing efforts to collect relevant data for assessment of value after a medicine reaches the market and starts to be used in clinical practice. It is only when medicines are used in clinical practice that the benefits for real-world patient populations can be identified, measured and valued. Analyses of real-world data will also assist further development and tailoring of treatment strategies to optimize the value of the new technology. While an effective patent system rewards innovation for a limited period of time, many innovations may continue to provide value to society long after patent protection, and these values must be included in the assessment of value of innovation.

scholarly journals An observational study «FOLLITROPIN» comparing the efficacy of follitropin alpha biosimilar: the real-world data

2021 ◽  
Vol 15 (1) ◽  
pp. 5-21
Author(s):  
D. P. Kamilova ◽  
M. M. Ovchinnikova ◽  
E. Sh. Ablyaeva ◽  
M. M. Leviashvili ◽  
N. S. Stuleva ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Observational Study ◽  
Clinical Efficacy ◽  
Real World ◽  
Ovarian Stimulation ◽  
Successful Implementation ◽  
Efficacy And Safety ◽  
The Real ◽  
Real Clinical Practice

Introduction. The efficacy and safety of biosimilar follitropin alpha have been demonstrated in randomized blinded prospective clinical trials of phases I and III. Unfortunately, there is a gap between the clinical trials and real clinical practice data. The real-world patient data helps to create an evidence-based background for successful implementation of medicine at everyday practice in a nonselected population.Aim: to investigate the efficacy of follitropin alpha biosimilar therapy (Primapur®) in nonselected real-world population.Materials and Methods. A retrospective observational anonymized cohort study of follitropin alpha biosimilar (Primapur®) as a pre-filled pen injector with a dose adjustment of 5 IU, aimed to investigate its efficacy and safety in a nonselected population with indications to assisted reproductive technologies (ART) was carried out. The ovarian stimulation (OS) protocols included: monotherapy protocols with using only Primapur®; mixed protocols (recombinant and urinary-derived gonadotropins); short protocols with using antagonists of gonadotropin-releasing hormone (GnRH) and long protocols with GnRH agonists. The stimulation protocols were analyzed with Primapur® application for at least 5 days.Results. The overall clinical efficacy of ovarian stimulation cycles (N = 5484) was: oocytes retrieved - 9.5 ± 7.2, mature (MII) - 6.8 ± 6.6, fertilized (2PN) - 6.1 ± 5.8, clinical pregnancy per ET (PR) - 38.4 %. Mixed gonadotropin protocols (N = 2625) vs. monotherapy with Primapur® (N = 2859): oocytes retrieved - 8.6 ± 6.8 vs. 10.3 ± 7.4 (p < 0.001), mature (MII) - 6.7 ± 6.2 vs. 7.7 ± 6.9 (p < 0.001), fertilized (2PN) - 5.8 ± 5.2 vs. 7.2 ± 6.2 (p < 0.001). There were statistically significant differences between oocyte yields in mixed vs. monotherapy protocols due to subgroup differences, including age, body mass index (BMI) and IVF/ICSI attempts. No statistically significant differences were found for PR: 39.3 % vs. 37.6 % (p = 0.314). Monotherapy protocols with GnRH antagonist OS (N = 2183) vs. GnRH agonist (N = 676) revealed: oocytes retrieved - 10.5 ± 7.5 vs. 9.6 ± 7.0 (p = 0.032), mature (MII) - 7.6 ± 6.9 vs. 6.7 ± 5.7 (p < 0.001), fertilized (2PN) - 7.3 ± 6.3 vs. 5.7 ± 5.0 (p < 0.001). There were statistically significant differences between BMI and IVF/ICSI attempts. No statistically significant differences were found for PR: 37.9 % vs. 35.9 % (p = 0.482). All medicines were well tolerated and no serious adverse reactions were reported.Conclusion. This was the largest retrospective observational study conducted in the field of fertility in Russia and involved 5484 ovarian stimulation protocols at 35 IVF clinics. The obtained results demonstrated similar clinical efficacy for follitropin alpha biosimilar Primapur® in different OS protocols in real clinical practice. 

scholarly journals Mobile apps for real-world evidence in health care

2020 ◽  
Vol 27 (6) ◽  
pp. 976-980
Author(s):  
Madison Milne-Ives ◽  
Michelle Helena van Velthoven ◽  
Edward Meinert
Keyword(s):  
Health Care ◽  
Mobile Health ◽  
Real World ◽  
Patient Empowerment ◽  
Real World Data ◽  
Privacy And Security ◽  
World Data ◽  
Health Apps ◽  
Real World Evidence ◽  
Mobile Health Apps

Abstract The use of real-world evidence for health care research and evaluation is growing. Mobile health apps have often-overlooked potential to contribute valuable real-world data that are not captured by other sources and could provide data that are more cost-effective and generalizable than can randomized controlled trials. However, there are several challenges that must be overcome to realize the potential value of patient-used mobile health app real-world data, including data quality, motivation for long-term use, privacy and security, methods of analysis, and standardization and integration. Addressing these challenges will increase the value of data from mobile health apps to inform real-world evidence and improve patient empowerment, clinical management, disease research, and treatment development.

Rivaroxaban real-world evidence: Validating safety and effectiveness in clinical practice

2016 ◽  
Vol 116 (S 02) ◽  
pp. S13-S23 ◽  
Author(s):  
A. Camm ◽  
Craig Coleman ◽  
CAPT Tamayo ◽  
Jan Beyer-Westendorf
Keyword(s):  
Clinical Practice ◽  
Real World ◽  
Clinical Decision Making ◽  
Current Knowledge ◽  
Oral Anticoagulants ◽  
Clinical Decision ◽  
Routine Clinical Practice ◽  
Real World Data ◽  
Real World Evidence ◽  
Randomised Controlled

SummaryRandomised controlled trials (RCTs) are considered the gold standard of clinical research as they use rigorous methodologies, detailed protocols, pre-specified statistical analyses and well-defined patient cohorts. However, RCTs do not take into account the complexity of real-world clinical decision-making. To tackle this, real-world data are being increasingly used to evaluate the long-term safety and effectiveness of a given therapy in routine clinical practice and in patients who may not be represented in RCTs, addressing key clinical questions that may remain. Real-world evidence plays a substantial role in supporting the use of non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) in clinical practice. By providing data on patient profiles and the use of anticoagulation therapies in routine clinical practice, real-world evidence expands the current awareness of NOACs, helping to ensure that clinicians are well-informed on their use to implement patient-tailored clinical decisions. There are various issues with current anticoagulation strategies, including under- or overtreatment and frequent monitoring with VKAs. Real-world studies have demonstrated that NOAC use is increasing (Dresden NOAC registry and Global Anticoagulant Registry in the FIELD-AF [GARFIELD-AF]), as well as reaffirming the safety and effectiveness of rivaroxaban previously observed in RCTs (XArelto on preveNtion of sTroke and non-central nervoUS system systemic embolism in patients with non-valvular atrial fibrillation [XANTUS] and IMS Disease Analyzer). This article will describe the latest updates in real-world evidence across a variety of methodologies, such as non-interventional studies (NIS), registries and database analyses studies. It is anticipated that these studies will provide valuable clinical insights into the management of thromboembolism, and enhance the current knowledge on anticoagulant use and outcomes for patients.

scholarly journals Registers as the basis for data collection and evidence building

2021 ◽  
Vol 1 (1) ◽  
pp. 10-15
Author(s):  
A. V. Ivanov
Keyword(s):  
Clinical Practice ◽  
Data Collection ◽  
Medical Practice ◽  
Real World ◽  
Medical Science ◽  
Real World Data ◽  
Constant Increase ◽  
Medical Technologies ◽  
Clinical Registries ◽  
Real Clinical Practice

The development of medical science requires a constant increase in the effectiveness and safety of treatment. Collection of real-world data (RWD) is one way of solving these problems. Clinical registries are one of the most important parts of this process. Clinical registries allow collecting data on the use of medical technologies and monitoring the results of therapy in real clinical practice. The introduction of patient registers and the collection of RWD data into widespread medical practice can help to optimize costs in the treatment of high-cost diseases and to better plan the budget.

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