Whilst EHRs used for routine clinical care have some limitations at present, new improved systems and emerging research infrastructures are being developed to ensure that EHRs can be used for secondary purposes such as clinical research, including the design and execution of clinical trials for new medicines. In some regions, including Scandinavia and the UK, electronic systems were first adopted by primary care, whereas in others, the development was led by university clinics in large hospitals. The transition into EHRs has been far from uniform in different parts of the world and has not mirrored general information communication technology (ICT) developments. In parallel, clinical research is on the threshold of a new era in which electronic health records (EHR) are gaining an important novel supporting role. Implications include for example the inability to contextualise any findings in the active control arm. Moreover, it may be difficult keeping severe asthma patients in the placebo arm of a long-term safety study data due to discontinuations. Difficulties enrolling severe asthma patients to long-term placebo controlled trials may have a negative impact on the development time of new innovative drugs, a disadvantage to patients in need. When the indication involves severe asthma, it may be an ethical challenge to randomize patients to a long-term safety follow-up in a control group receiving placebo.

Development of a new drug requires extensive documentation of effectiveness and safety, usually by comparison with a placebo control group in a RCT. There is a broad spectrum of novel therapeutic agents currently under development for the treatment of severe asthma. These patients have an increased risk of developing severe exacerbations, suffer from a poor quality of life, and pose a high economic healthcare burden. The prevalence of asthma in Sweden is 8-10% and pharmacological treatment to relieve symptoms and maintain optimal lung function is required, but despite various treatment options, a large proportion of patients have asthma that remains uncontrolled. Asthma is a common but complex heterogeneous chronic inflammatory disease of the airways, which presents with variable symptoms of cough, breathlessness, and wheeze, with episodic acute worsening of symptoms known as exacerbations, particularly in severe asthma.

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