Clinical studies are research studies performed on human subjects with a view to furthering biological or medical knowledge. These studies require collecting data on patients or healthy volunteers, to better understand physiological or pathological conditions, identify potential risk factors, and/or evaluate the benefits and risks of interventions. User experience studies (see box below for other denominations) are a valuable tool for evaluating users’ feedback on a drug, a medical device, a food supplement, a cosmetic product, or any kind of intervention that deals with health or well-being. Clinical and user experience studies have complementary roles: while the former collect health-related data, the latter collect data related to satisfaction, perception, taste, ergonomics, etc. The sensitive nature of health-related data means they require a tight regulatory framework, so that they cannot be collected as part of a user experience study. Depending on the product, both types of studies can be necessary at different stages of the product development chain. Both share the aim of improving subjects’ health and quality of life, either via direct evaluation of efficacy, performance and safety for clinical studies, or via improvement of the experience with and acceptability of the intervention for user experience studies. Therefore, it is important to understand the advantages and limitations of both types of studies.
Non-clinical studies have many names:
- User experience study
- Health consumer experience study
- Usability study
- Usage study
- In-home use study
Clinical trials collect reliable health–related data and are tightly regulated
By definition, a clinical trial is conducted on human beings and aims at developing biological or medical knowledge. Clinical studies can be divided into two main categories, depending on the impact of the study procedures on the participants and the associated risks: interventional studies, also known as clinical trials, and observational studies.
On the one hand, clinical trials aim at increasing knowledge about a particular treatment or intervention: how it is absorbed, metabolised, or excreted by the human body, how it interacts with physiological processes, how it can prevent or treat a disease, to what extent it induces side effects, etc. Typically, in this type of trial, the product is compared to a placebo or a standard intervention, and subjects are randomly and blindly assigned to a treatment group, to gather unbiased and reliable information on efficacy and safety. Interventional trials involve administration of products, use of devices and implementation of procedures additional to those warranted by the subject’s usual care. This introduces a vast range of risks which need to be carefully weighted in view of expected benefits, and mitigated as much as possible. The benefit/risk ratio must systematically be evaluated by an independent ethics committee whose approval is mandatory before starting the study. The authorisation of the competent authority is also required in most cases: the ANSM in France, the MHRA in the United Kingdom, the BfArM in Germany, the AIFA in Italy, the EMA at the European level, the FDA in the United States, and so on.
Observational studies, on the other hand, investigate what happens to participants in real life conditions, without influencing subjects’ treatments or care procedures. Cohort studies, case control and cross-sectional studies are all examples of observational studies. Cohort studies follow a large group of individuals over a period of time to gather information on specific outcomes: occurrence of diseases, precise conditions, changes in health status, appearance of risk factors, etc. Case-control and cross-sectional studies aim at comparing control and disease groups for a certain pathology or condition, to identify a possible link with risk factors. Observational studies can be designed to assess treatment compliance, tolerability or efficacy of a medicinal product in real life conditions, once it is on the market. No additional risk is expected for the participants, as they are treated and monitored according to standard care. The only risk is related to the collection of sensitive personal data, so that the approval of an independent ethics committee (but not of a competent authority) is also mandatory.
Whether interventional or observational, clinical studies collect health data of various origins. These measures can be objective, provided that the experimental protocols and methods of measurement are standardised (e.g.: weight, blood pressure, sleeping duration, fasting glycaemia, skin hydration, relative abundance of a bacterial genus in the faecal microbiota, etc.). They can be more subjective, such as the assessment of depression through a medical interview or via the subject’s self-assessment. The latter situation corresponds to Patient Reported Outcomes (PROs), which are defined as any report coming directly from patients, without interpretation by physicians or others, about how they function or feel in relation to a health condition and its therapy. In all cases (doctor’s assessment or PRO), it is recommended to use validated questionnaires, that are recognised by regulatory authorities and the scientific community.
Note that some research studies on humans that deal with health data do not require ethical and regulatory approval: studies that analyse data previously collected for other purposes (retrospective studies) and studies on biological samples taken during care fall outside the clinical research regulation: they must be declared but not approved.
User experience studies help address marketing strategies and are easy to implement
Research that does not aim at developing biological or medical knowledge faces fewer regulatory constraints. If no health-related data is collected, there is no need to seek approval from an ethics committee nor a competent authority: the study is out of the scope of regulation on clinical research. Of course, compliance with the provisions of local legislation on personal data protection is required, as for all data collection. User experience tests cover a wide range of studies focused on the development and improvement of products, systems, or interfaces, to match users’ expectations. These types of studies have a user-centred design, to help understand how users interact with a product, how they perceive it, and how satisfied they are with it. They will not support health claims but will provide useful information to optimise the product itself, or its packaging, considering its target users and real-world use environment. These are marketing assets that can make a difference with the competitors.
For example, user experience studies can provide insight on the best formulation for a food supplement (powder, capsule, or tablet form) for adults or children, or on wellness or aesthetic satisfaction of a cosmetic product (skin hydration, radiance, fragrance after use). In the field of medical devices, user experience studies provide usability data, which play a pivotal role in the product development and post marketing phases, since they allow to investigate user-product interaction, if a device is user-friendly, if it requires training and learning to be properly used, and if it can reasonably fulfil its intended purpose in real-life conditions.
User experience studies are based on Patient- (or Participant-) Reported Experiences (PREs), which deal with how the person perceives his or her care, including the easiness of use of a product, the time spent using it, the time waiting for a medical appointment, the quality of communication with healthcare providers, the knowledge about his or her physical condition or feeding recommendations, etc. Satisfaction is another key piece of information to collect in user experience studies: it reflects how a product (or a treatment, or a diet) matches with the subject’s expectations.
These types of studies can also add marketing value for commercialised drugs, by testing whether a format of packaging is ergonomic or if labelling is comprehensible, and then adapting safety communications and improving mitigation strategy instructions.
Health data are complementary to user experience data to optimise the benefits of a product, at user level and manufacturer level
User experience studies and clinical studies both follow the principles of scientific methodology: they originate from a research question that must be addressed through specific methods to verify a working hypothesis. Both clinical trials and user experience studies are often conducted by using questionnaires (PROs, PREs, or satisfaction, as described above), or ad-hoc scales or questions. The questionnaires can be generic, focusing on parameters applicable to any subject, or specific, depending on the study’s scope and population. Smart devices can be useful to collect objective data (e.g.: bedtime, daily walking steps, compliance with lifestyle recommendations) and facilitate data entry by the subject (website, smartphone app).
In some cases, the border between health data and user experience may be subtle. For example, a food product dedicated to weight management can be observed from the angle of user wellbeing and satisfaction, or from a medical perspective to improve metabolism, so that it will be part of a user experience study in the first case, and of a clinical study in the second. Similarly, a study on a topical cream can measure skin hydration as a cosmetic property, to promote a pleasant feeling, or as biomarker of dermatological health, to improve the skin’s barrier function. Beyond the wording, the choice of objectives and endpoints will place the study into one or the other category, with different regulatory pathways.
Clinical studies are mandatory for medical progress and for the safety and effectiveness assessment of drugs and medical devices. They are optional for dietary supplements or food ingredients (except to obtain a health claim, in which case they are essential), and for cosmetics. User experience studies provide further information, with the user placed at the centre of interest. For this reason, clinical studies and user experience studies should be considered complementary in achieving the best results for care.
