What are the new developments and opportunities of RWE use cases in 2020?

At the end of the year, looking forward to the coming new year, what are the new developments and trends of real world evidence use? How should the pharmaceutical industry respond? For those who want to do something in the biomedical industry in the future, it is very important to understand and predict the development trend of health care decision-making in the rapidly changing environment A few days ago, syneos Health & Insights hub released the health care industry trend 2020 report The report brings together the views of hundreds of experts working at the forefront of the biomedical industry We will introduce the development trend of health care industry in 2020 in detail in this report In the coming 2020, it is crucial to understand people's response to therapeutic drugs in the complex real world From building organizations' in-depth understanding of real world evidence (RWE) to learning new methods of injecting data into clinical trial design, pharmaceutical industry leaders are helping their teams exceed regulatory requirements and expectations of payers, and continue to demonstrate and prove the influence of the industry In the past few years, to a large extent, pharmaceutical companies have seen RWE create stable value for patients and stakeholders Most pharmaceutical industry leaders believe that this is a key success factor in obtaining and adopting new therapeutic drugs More and more health care decision makers recognize that, no matter the payer, medical service provider, patient rights group, clinical guide maker, or regulatory agency, there is no exception In addition to traditional safety and effectiveness measures, RWE based on outcome data needs to be considered Comprehensive organizational change is still the biggest challenge facing the pharmaceutical industry Leaders are working hard to reach a consensus on RWE among all relevant companies If this fundamental problem is not handled properly, it will hinder the company from making a strong RWE research agenda, undermine the ability to advance within the organization, and thus seriously hinder the efforts to successfully launch new therapies Companies that have not yet achieved a broad and in-depth understanding of RWE may face the following three challenges in the next year: Once these challenges are overcome, companies will begin to see the next key shift: timing In order to obtain a highly selective prescription set, real-world data collection has become more important since the first phase of clinical practice In 2020, the expectation of payers for integrated data is higher than ever before Pharmaceutical companies are learning more about new methods of data collection and new regulatory guardrails around RWE For example, in 2008, FDA realized the sharing of pre approval data with population-based decision makers, but not all organizations learned how to integrate these data into their own internal guidelines and systems In addition to the clinical trials, payers have also implemented stricter evidentiary requirements that need to be overcome, such as conditional reimbursement and other restrictions Therefore, in 2020, it will be a priority for the pharmaceutical industry to have an in-depth understanding of real world evidence throughout the organization Synthetic clinical trial is considered as a modern retrospective study The development of synthetic clinical trial provides more possibilities for fewer patients to participate in clinical trials From the electronic medical record (her) to data integrator, and then to authorized patients to collect their own data, the number of de identified patients' data has increased dramatically In addition to de identifying patient data, there is a detailed summary of all unused data from large clinical trials In the new decade, in order to make full use of these data, innovators are increasingly carrying out synthetic clinical trials Using existing data to collect synthetic clinical trials of RWE can be seen as requiring fewer patients to participate in clinical trials At present, the synthetic clinical trial tends to take the form of clinical trial arm, as a part of large-scale clinical trial scheme, that is to take the form of sub project research For example, extensive studies of blood pressure may benefit from sub studies targeting different ethnic groups This is a relatively simple data classification However, more and more synthetic clinical trials tell us where the starting point is The industry can analyze and synthesize clinical trial data to determine the best treatment effect patient queue, so as to replace the method of carefully exploring the data about race These data, often used in conjunction with other data sets, can point to new signals, including new indications For some light pipelines, leaders in the pharmaceutical industry will ask: what other influence can therapeutic drugs bring? Once these signals are identified and recognized, the relevant pharmaceutical companies may only need to carry out small-scale controlled clinical trials, rather than carry out comprehensive clinical research With the right data, innovators can be very close to the results, even if they can't get them directly When the pharmaceutical industry first entered the field about two years ago, synthetic data was used as a placebo control arm Relevant composite data, used to represent patients in standard treatment care, required the study to recruit only half the number of patients in general as the test arm Looking to the future, valuable data is the key The National Health Service (NHS) in the UK is regarded as one of the important supports of this competition Some of the world's largest pharmaceutical companies and technology entrepreneurs value the huge potential of data covering the entire life course of about 65 million patients covered by the NHS These signals can be found to point to new therapies, which are helpful for early detection of new therapies for diseases, as well as the basic information of patients most suitable for clinical research As the NHS seeks new healthcare hopes and new financial support, companies such as Google, Bayer and Roche want to enter the data sharing market The value of this data sharing market is expected to reach $10 billion a year soon The implementation of the 21st century cures Act allows more leaders to develop evidence that there is no placebo control With the aid of adaptive testing, the pharmaceutical industry is able to view data more frequently to determine when a product or drug administration is not working in the best way and to improve the ability to make changes to relevant participants In short, adaptive clinical trials allow the team to adjust and modify the trial process using predetermined rules This method can help researchers to use less intervention to patients, save time, improve the relevance of test results, and effectively reduce the resources needed to complete the study Until recently, almost all clinical trials followed the same sequential approach as shown in the following figure: If the relevant data meet the end point in the original design, it means good news and the test will be considered successful However, there are often problems in the preliminary design: for example, when the administration can be a, B or C, adaptive design enables innovators to introduce these assumptions and track the results in real time When an option becomes the leader, clinical trials tend to focus on the confirmation of the results of the placebo-controlled trials One of the key points of virtual trial is to reduce the intervention of clinical trial site But virtual clinical trials do not exist in the form of either or, but in the form of similar spectrum of "you have me, I have you": there are completely virtual trials, and there are also mixed clinical trial methods In addition to the traditional data analysis and some adaptive designs, the centralized statistical analysis is also used to identify and determine the data abnormalities that may be distorted by the internal errors of patients and the errors between patients Most of the electronic data acquisition is correct, but once the electronic data acquisition errors, it will have a significant impact on the research speed and success The centralized monitoring team uses real-time data to find and identify abnormal values through pattern method, error marking, and getting rid of the dependence on pre-defined data inspection With the help of statistical monitoring, visualization, and patient profiles, it can help to find data quality problems that have not been found before Many companies are only now aware of the new normal that is coming or has come In this new normal, business success depends on support for RWE The industry must improve the understanding of RWE, and really realize that RWE is very important for individuals and the whole clinical development and commercialization process In 2020, the industry will assess the opportunity to apply adaptability considerations in its development plan It is necessary for the industry to strengthen the seamless design of phase 2-3 clinical trials, new biomarker signals, and more complex mid-term analysis and adjustment technology through careful planning and in-depth epidemiological knowledge acquired through RWD With fewer patients in clinical trials and single arm design, RWD can be used to identify and determine external controls, which can make the trial more efficient, more valuable and has considerable potential Expanding the use of RWD in a more creative way, supporting evidence generation and accelerating drug development will be a priority in 2020 Original title: viewpoint | real world evidence use case: what are the new developments and opportunities in 2020? 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