The TARGET Model
The TARGET model designs and sponsors disease-specific observational studies to create large, diverse cohorts of patients to generate valuable real-world evidence that is playing an increasing role in today’s health care decisions.
This is achieved through organizing communities of stakeholders, including pharmaceutical manufacturers, key opinion leaders (KOLs), regulatory agencies, and patient advocacy groups, around a specific disease to generate these insights.
TARGET has established relationships with 200+ community and academic sites to improve patient diversity and understandings about populations typically underrepresented in phase III trials. This provides reliable, high-quality data and insights about the natural history of the disease, clinical outcomes, post-marketing safety, and detailed patient reported outcomes, which will improve our knowledge of the disease, accelerate product development, and ultimately improve patient care.
The TARGET model utilizes a multidisciplinary approach that involves thorough research on each disease community from the following committees: academic, advisory and publications.
Academic Steering Committee
Each TARGET disease community begins with the creation of an academic steering committee of disease experts and world-class key opinion leaders to guide protocol development and study design, including the creation of each study’s research plan.
TARGET has advisory committees for each disease that is made up of industry partners, regulatory agency representatives, and patient advocacy groups to strengthen the understandings and challenges of the diseases.
TARGET collaborates with industry partners, Principal Investigators and academic steering committee members to create peer-reviewed abstracts and manuscripts that address scientific gaps in knowledge. TARGET abstracts are presented at national and international scientific conferences and submitted to high-quality peer reviewed journals.
The TARGET data management and statistics team is responsible for the development and maintenance of the databases for each of our TARGET Communities, as well as the analysis and reporting of the data. TARGET utilizes innovative methodologies for predictive analytics and machine learning, epidemiology, biostatistics, and data visualization to provide robust and informative solutions for our partners’ needs.
TARGET's technology assists community-focused abstractors to review electronic medical records, where much of the health information is captured in an unstructured format. Data is curated according to pre-defined guidelines to maximize consistency and quality of our data. Once entered, numerous edit checks are implemented, and medications and events are coded using medical dictionaries common to the regulatory environment (e.g. MedDRA, WHODRUG). Data of critical importance are further monitored against the source medical records for accuracy, consistent with the community-specific monitoring guidelines.
Patient Reported Outcomes
TARGET supplements the data available from medical records with periodic assessments of patient reported outcomes. This includes multiple validated surveys specifically chosen for each disease to elucidate patient well-being and disease status.
TARGET collects blood, serum, and tissue biospecimen samples at scheduled intervals for genomic discovery. These data will help to identify important biomarkers related to disease severity, heterogeneity, and disease progression. Partners have access to biospecimen samples for their own research on a first-come, first-serve basis.