Total of 25 published articles:
- Sustainable Innovation (2 articles)
- Innovative Design and Methodologies (7 articles)
- Biosimilars Strategy (5 articles)
- Therapeutic Insights and Patient-Centricity (12 articles)
| Sustainable Innovation (2 articles) DCTs offer patient engagement and need a strategic path to sustainability and operational resilience. Singh et al. 1 (2023): Design and Execution of Sustainable Decentralized Clinical Trials. Singh et al. 1 (in progress ~2025): Global Perceptions on Trial Sustainability Decision-Making Criteria. | Therapeutic Insights and Patient-Centricity (12 articles) Target diverse therapeutic needs with tailored approaches focusing on efficacy, safety, and quality of life. COVID-19 Buenconsejo et al. (2023): Platform trials to evaluate the benefit-risk of COVID-19 therapeutics: Successes, learnings, and recommendations for future pandemics. Chan et al. (2021): Critical Elements in Communication of Vaccine Trial Results. |
| Innovative Design and Methodologies (7 articles) Implement methodologies to enhance decision-making, trial design, and analysis precision and efficiency. Dharmarajan et al. (2024): Incorporating Prior Data in Quantitative Benefit-Risk Assessments: Case Study of a Bayesian Method. Beckman et al. (2022): Advancing innovative clinical trials to efficiently deliver medicines to patients. Hampson et al. (2021): A New Comprehensive Approach to Assess the Probability of Success of Development Programs Before Pivotal Trials Casoli et al. (2020): Bayesian methods in pharmaceutical research. Ratitch et al. (2019): Choosing Estimands in Clinical Trials: Putting the ICH E9(R1) Into Practice. Mallinckrodt et al. (2019): Aligning Estimators With Estimands in Clinical Trials: Putting the ICH E9(R1) Guidelines Into Practice. Ratitch et al. (2019): Defining Efficacy Estimands in Clinical Trials: Examples Illustrating ICH E9(R1) Guidelines. | Therapeutic Insights and Patient-Centricity (Continued) Parkinson’s Disease Kim et al. (2015): Rotigotine transdermal system as add-on to oral dopamine agonist in advanced Parkinson’s disease. Antonini et al. (2015): Effects of rotigotine transdermal patch in patients with Parkinson’s disease presenting with non-motor symptoms. Chung et al. (2015): Switch from oral pramipexole or ropinirole to rotigotine transdermal system in advanced Parkinson’s disease. Epilepsy Toublanc et al. (2015):Pharmacokinetics, Safety and Bioequivalence of Levetiracetam Intravenous Infusion and Oral Tablets in Healthy Chinese Subjects. Attention Deficit Hyperactivity Disorder Mendez et al. (2011): Academic outcomes in Asian children aged 8-11 years with attention-deficit/hyperactivity disorder treated with atomoxetine hydrochloride. |
| Biosimilars Strategy (5 articles) Unlocking cost-effective treatment options with biosimilar development strategies. Blackwell et al. (2016): Comparison of biosimilar LA-EP2006 and reference pegfilgrastim in preventing neutropenia in breast cancer patients. Harbeck et al. (2016): Randomized study comparing biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer. Becker et al. (2016): Healthy donor hematopoietic stem cell mobilization with biosimilar granulocyte-colony-stimulating factor. Blackwell et al. (2015): Comparison of EP2006, a filgrastim biosimilar, to the reference in breast cancer patients receiving chemotherapy. Sörgel et al. (2015): Comparability of biosimilar filgrastim with originator filgrastim. | Therapeutic Insights and Patient-Centricity (Continued) Major Depressive Disorder Li et al. (2010): Association between painful physical symptoms and clinical outcomes in Chinese patients with major depressive disorder. Chen et al. (2010): Association between painful physical symptoms and clinical outcomes in Taiwanese patients with major depressive disorder. Lee et al. (2009): Association between painful physical symptoms and clinical outcomes in Korean patients with major depressive disorder. Ang et al. (2009): Association between painful physical symptoms and clinical outcomes in East Asian patients with major depressive disorder. Schizophrenia, Bipolar disorder Treuer et al. (2009): Factors associated with weight gain during olanzapine treatment in patients with schizophrenia or bipolar disorder. |
| 1 Published with Pritibha Singh as the first author and with other publications as a co-author. | |
English