Healthcare companies are now refocusing their attention on patient centricity, moving beyond lip service to real patient engagement. This has been prompted by greater patient – and caregiver – involvement in treatment decisions and bearing costs. Patients are empowered with digital information, organized in advocacy groups and are even funding clinical trials using innovation partnership models. Medical technology firms are similarly motivated to decode patient motivation and behavior as they digitize and harness patient-generated data.
Our clients must balance their traditional emphasis on healthcare provider (HCP) engagement with patient and caregiver engagement. Consumer healthcare companies have traditionally been ahead of their Rx and medtech peers in decoding patients as people, understanding the broader consumer and shopper context, including how patients live, work and play.
The desire for patient insights is also fueled by greater access to patient-level data and a desire for reported outcomes and other forms of real-world evidence, both digital and analog. Our clients are interested in the patient’s burden of disease, the emotional and functional journey, and unmet patient needs. We support our clients by assembling scientifically sound outcomes and evidence to make patient centricity come alive.
These studies measure the impact of patient and/or healthcare provider (HCP) communications campaigns. We gauge awareness, familiarity, and knowledge of patients and HCPs about a specific disease category, its treatment and associated benefits.
In the course of a self-administered online interview, study respondents are exposed to various stimuli from the communications campaign, and asked about recall, messages familiarity and the impact of the information on patient behavior, such as likelihood to ask for specific treatments, medication behavior, adherence, etc.
These studies inform pre-launch and post-launch communications, ensuring that the right messages are delivered to the right audiences, with the purpose of educating patients and HCPs about clinical research and benefits of treatment (early treatment, combination treatment, etc.), and ultimately leading to improvement in patient outcomes.
GfK Health quantifies direct and indirect care and types of burden, and investigates burden by patient segments. Our research findings are often submitted to peer-reviewed scientific journals and presented at medical congresses and conferences.
Typically, test and control groups of caregivers and/or patients are surveyed. The survey design is guided by hypotheses and market knowledge. Validated burden of illness scales are typically included in the survey instrument.
These studies raise awareness of the patient’s and caregiver’s burden, clearly demonstrate an unmet need for better treatment options and prime the market in advance of better treatment launches.
We use validated instruments to measure and assess patient-reported outcomes (PROs) and health-related quality of life (HR-QoL).
To capture patient outcomes, we incorporate validated HR-QoL health instruments within patient surveys. We use general health measures, such as SF-12 and EQ-5D-5L, in addition to specific disease instruments, such as the chronic liver disease questionnaire (CLDQ) for non-alcoholic steatohepatitis (NASH) and Dermatology Life Quality Index (DLQI) for dermatological diseases. Our scientific online PROs use uniquely representative panels, such as our KnowledgePanel. In fact, hundreds of articles with GfK Health data have been published in peer-reviewed journals and presented at conferences.
Established evidence indicates that patients on particular therapies achieve better outcomes, which result in less burden and fewer symptoms, and aid in the understanding of patients’ needs in order to tailor patient support services.
Self-reported patient data are linked to clinical patient chart data, capturing differing attitudes and behaviors. The type of information scoped in a typical study includes patient demographics, disease characteristics, consultation and treatment history, perceptions, patient-reported outcomes via validated instruments and medical resource use.
Physicians complete online medical charts retrospectively, each of which takes approximately 15 to 20 minutes to complete, for the next 5 to 10 consulting patients that meet the defined inclusion criteria (to avoid selection bias). These patients are subsequently recruited by the physician to voluntarily complete a 10- to 12-minute patient survey (without incentive to avoid selection bias). These studies are a robust, real-world source of epidemiology for that population as set within the criteria. Implementing inclusion criteria creates a sample, which is as close to the real-world consulting population as is feasible within the confines of primary market research, to obtain a broad and deep overview of the marketplace/landscape, with no prior hypotheses being set before field is obtained.
These studies can deliver an assessment of the market’s changing landscape, unmet needs, as well as competitor dynamics, to aid in shaping future clinical behavior. In addition, through linking the burden of disease on the patient’s quality of life to the patient’s clinical journey, resource utilization and coverage, gaps in the care continuum can be identified. The resulting targeted evidence can aid in building value stories that resonate across stakeholders, as well as in publications to shape stakeholder opinions, change behaviors and influence guidelines for better standards of care.
Prospective and retrospective non-interventional studies (NIS) studies – cohort, case-control, cross-sectional and others – describe the practice of a medication‘s use in a real patient’s life. NIS studies collect data on medications prescribed by physicians, not in accordance with a research protocol, but with routine practice of the disease treatment. The approach does not consider any additional clinical interventions to be introduced to a patient.
We conduct these studies in cooperation with dedicated clinical and epidemiological research consultants, and have already gained considerable experience in organizing such projects all over the world. Our accumulated data on patient-reported outcomes (PROs) open up exciting opportunities for retrospective analysis and constitute the basis for prospective surveillance programs development.
NIS studies broaden the knowledge gained through clinical studies and provide the fullest picture of a medicine’s efficacy, safety, influence on a patient’s quality of life and possibility of application in specific patient groups.
Initiated by regulatory bodies or manufacturing companies themselves, post-marketing safety surveillance is focused on estimating the frequency of adverse events in patients’ everyday lives.
Our main priority in safety surveillance monitoring is building a robust system of data collection, ensuring strict observance of international and local regulations, high data quality and compliance with adverse events reporting standards. Operational success is achieved through the superior management skills of our team, and deep knowledge and data collection experience in different areas of the pharmaceutical market.
Safety surveillance monitoring delivers evidence based on a medicine’s safety, and justifies its presence on the market for regulatory bodies. These studies help improve clinical recommendations and support pharmacovigilance risk management systems.
Longitudinal studies represent one of the non-interventional research approaches. Based on repeated observations of the same patient over short or long periods of time, longitudinal research design enables us to establish a continuous patient history and identify a clear sequence of events.
Depending on the study objectives, data in prospective longitudinal studies can be collected either through setting up a permanent panel of physicians who regularly record data for their patients, or through repeated interviews with patients engaged in the survey by their treating physicians. Based on our international experience and cultural patterns of each country, we define and use the most effective data collection method. To ensure the high response rate and validity of the results, we maximize our efforts in supporting participants’ engagement and interest for a long period of time. We follow international ethical standards and strictly adhere to personal data protection procedures.
This study type is appropriate for future disease prognosis, evaluation of the relationship between risk factors and the disease development, and outcomes of treatments over different lengths of time. Longitudinal studies help identify the level of patient compliance and determine if existing patient programs and physicians’ support materials have been successful in their objectives.