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Email UsOPTICS: Open Translational Science in Schizophrenia
This initiative of the Harvard Catalyst Translational Innovator Program, which was a follow up to the ReSourcing Big Data Symposium, enabled collaboration with the OPTICS Project. This opportunity allowed qualified investigators access to complete data from clinical trials in schizophrenia (Janssen Pharmaceuticals) and from related observational studies and trials in schizophrenia (NIH-dbGaP; NIMH-CATIE). Funding of up to $50,000 was available to support collaborative analysis of the open-source schizophrenia data sets. The goal of this opportunity was to support collaborations leading to insights about schizophrenia and:
- Therapeutic safety and efficacy;
- Disease understanding including natural history, subtypes, etiologies, etc.
- Statistical methods development
Three pilot grants were awarded. Funding decisions were announced in December 2015.
Sponsoring Program
Awardees
Principal Investigator: Karestan Koenen, PhD, Harvard T.H. Chan School of Public Health
The gold-standard for analyzing randomized trials is the intent-to-treat design. This is often unattainable in trials of schizophrenia therapy where study dropout often exceeds 33%. When dropout is related to poor efficacy (or emergent side-effects), it is often described as “informative” because it predicts treatment effectiveness (or safety). This study will develop and apply diagnostics for this informative dropout in several of the datasets that will be made available.
Principal Investigator: Sharon-Lise Normand, PhD, Harvard Medical School
Understanding antipsychotic risks is critical as these risks exacerbate the health burden of people with schizophrenia and add to the long-term economic burden borne by public payers. Methodological advances in two related research fields, causal inference and network meta-analysis, will be used to develop an approach to answer the questions involving the relationship between duration of drug exposure and outcomes.
Principal Investigator: Linda Valeri, PhD, McLean Hospital
Differences among antipsychotic medications for treatment of schizophrenia spanning from targeted mechanism of action, side effects and efficacy have been observed in randomized trial settings and in clinical practice. Explaining why differences in efficacy are observed is important to inform development of new drugs and to guide appropriate treatment strategies. The goal of this proposal is to apply a causal mediation approach, where the role of intermediate endpoints are used to explain how treatment affects the final outcome. This work has the potential to produce important insights on the interplay of symptoms and side effects in explaining the efficacy of second generation antipsychotics from randomized trials in schizophrenia.