Tufts CSDD maintains a number of core databases:
INVESTIGATIONAL COMPOUNDS DATABASE
The Investigational Compounds Database includes information on pharmaceutical and biological compounds that have entered human testing as “new” entities in the U.S. or abroad by drug and biotechnology companies since 1963. The information contained in the database includes development history, research activity, origin of the compound, and foreign marketing data.
APPROVED PRODUCTS DATABASE
This Approved Products Database includes information on all New Molecular Entities (NMEs) and New Biological Entities (NBEs) approved in the U.S. since 1963. Specific data include product origin, synthesis data, clinical phase lengths, clinical holds, development and regulatory review times, regulatory review history, and marketing history.
The Biotechnology Database contains data on over 2,400 investigational and marketed biopharmaceutical therapeutics including recombinant proteins, monoclonal and polyclonal antibodies, purified proteins, synthetic peptides, and antisense nucleotides. Data for prophylactic and therapeutic vaccines are included.
FAST TRACK DESIGNATION DATABASE
The Fast Track Designation Database contains information gathered from the public domain and other sources on products that have received fast track designations. These designations are given by the FDA to chemical and biological products, either in development or approved, that are intended to treat serious or life-threatening conditions, and to address an unmet medical need. The database is updated regularly to include the most recently designated products.
ORPHAN DRUG DATABASE
The Orphan Drug Database contains drug name, sponsor, dates of designation and approval, and orphan indication information on all orphan drug designations and approvals granted by the FDA from January 1983 to the present.
The EMEA Database contains information on drugs that have been approved through the EMEA’s Centralized Procedure starting in 1995 (the year of the Centralized Procedure's inception). For those approvals that have received both EMEA and FDA approval, the U.S. regulatory information is included for comparative analyses. The database includes information on approval time, regulatory designation, novelty of compound, and compound type.
DIVERSITY AND INCLUSION DATABASE
The Diversity and Inclusion Database contains detailed information on participant demographics in pivotal trials for drugs and biologics that have been approved by the FDA since 2007. The database includes information on drug and biologic therapeutic area, disease condition, molecule type, regulatory review designation, and participant sex, age, race, and ethnicity. Coming soon: Tufts CSDD is in the process of adding data on participant diversity and inclusion in pivotal trials of EMA-approved drugs and biologics.
CLINICAL TRIAL SCOPE, CYCLE TIME AND COST DATABASE
The Clinical Trial Scope, Cycle Time and Cost Database contains data on 400+ new drugs and biologics approved by the FDA’s Center for Drug Evaluation and Research since 2008. The database includes detailed data on the number of investigative sites, geographic locations, patients enrolled, duration, and estimated direct costs.
PROTOCOL DESIGN PRACTICES AND PEFORMANCE DATABASE
The Protocol Design Practices and Performance database contains rich data on several hundred protocols. Among the more than 140 variables captured in this database are detailed data on endpoints, procedures, eligibility criteria, number of investigative sites, patients screened, patients enrolled, substantial amendments, start-up cycle times, study conduct cycle times, study close out cycle times, clinical data volume, data sources, screen failure rates, recruitment rates, and drop out rates.