Female reproductive life cycle and hormones: methodology to improve clinical trials.
Authors: M. Freeman; R. Walker; T. Laughren; K. Miller; M. Fava
Year: 2013

Potential conflicts of interest: Dr Freeman has been a consultant for PamLab; received grant/research support from Eli Lilly, Forest, and GlaxoSmithKline; been on advisory boards of Lundbeck, Takeda, Johnson & Johnson (pending), and Otsuka; and been a medical editor for DSM Nutritionals. Dr Laughren is a part-time employee of the Massachusetts General Hospital Clinical Trials Network and Institute and has been a consultant for National Institute of Mental Health, Cerecor, Edgemont, Theravance, Neuren, Johnson & Johnson, Roche, Naurex, EnVivo, Shire, Zogenix, Corcept, Dart NeuroScience, AbbVie, Fabre-Kramer, MedAvante, ERT, and the law firms Quinn Emanuel and Ulmer & Berne. Dr Fava has received research support from Abbott, Alkermes, Aspect Medical Systems, AstraZeneca, BioResearch, BrainCells, Bristol-Myers Squibb, CeNeRx, Cephalon, Clintara, Covance, Covidien, Eli Lilly, ElMindA, EnVivo, Euthymics Bioscience, Forest, Ganeden Biotech, GlaxoSmithKline, Harvard Clinical Research Institute, Icon Clinical Research, i3 Innovus/ Ingenix, Janssen, Jed Foundation, Johnson & Johnson, Lichtwer Pharma GmbH, Lorex, MedAvante, National Alliance for Research on Schizophrenia and Depression, National Center for Complementary and Alternative Medicine, National Institute of Drug Abuse, National Institute of Mental Health, Neuralstem, Novartis AG, Organon, PamLab, Pfizer, Pharmaceutical Research Associates, Pharmavite, PharmoRx, Photothera, Roche, RCT Logic (formerly Clinical Trials Solutions), Sanofi-Aventis, Shire, Solvay, Synthelabo, and Wyeth-Ayerst; has been an advisor/consultant for Abbott, Affectis AG, Alkermes, Amarin, Aspect Medical Systems, AstraZeneca, Auspex, Bayer AG, Best Practice Project Management, BioMarin, Biovail, BrainCells Inc, Bristol-Myers Squibb, CeNeRx, Cephalon, Cerecor, CNS Response, Compellis, Cypress, DiagnoSearch Life Sciences, Dainippon Sumitomo, Dov, Edgemont, Eisai, Eli Lilly, EnVivo, ePharmaSolutions, EPIX, Euthymics Bioscience, Fabre-Kramer, Forest, GenOmind, GlaxoSmithKline, Grunenthal GmbH, i3 Innovus/Ingenis, Janssen, Jazz, Johnson & Johnson, Knoll, Labopharm, Lorex, Lundbeck, MedAvante, Merck, MSI Methylation Sciences, Naurex, Neuralstem, Neuronetics, NextWave, Novartis AG, NuPathe, Nutrition 21, Orexigen, Organon, Otsuka, Pamlab, Pfizer, PharmaStar, Pharmavite, PharmoRx, Precision Human Biolaboratory, Prexa, Puretech Ventures, PsychoGenics, Psylin Neurosciences, Rexahn, Ridge Diagnostics, Roche, Sanofi-Aventis, Sepracor, Servier, Schering-Plough, Solvay, Somaxon, Somerset, Sunovion, Supernus, Synthelabo, Takeda, Tal Medical, Tetragenex, Teva, TransForm, Transcept, and Vanda; has had speaking/publishing-related affiliations with Adamed, Advanced Meeting Partners, American Psychiatric Association, American Society of Clinical Psychopharmacology, AstraZeneca, Belvoir Media Group, Boehringer Ingelheim GmbH, Bristol-Myers Squibb, Cephalon, CME Institute/Physicians Postgraduate Press, Eli Lilly, Forest, GlaxoSmithKline, Imedex, MGH Psychiatry Academy/ Primedia, MGH Psychiatry Academy/Reed Elsevier, Novartis AG, Organon, Pfizer, PharmaStar, United BioSource, and Wyeth-Ayerst; has equity holdings in Compellis and PsyBrain; holds a patent for Sequential Parallel Comparison Design, which are licensed by MGH to RCT Logic, and has a patent application for a combination of scopolamine and ketamine in major depressive disorder; receives copyright royalties for the MGH Cognitive & Physical Functioning Questionnaire, Sexual Functioning Inventory, Antidepressant Treatment Response Questionnaire, Discontinuation-Emergent Signs & Symptoms, and SAFER; Lippincott Williams & Wilkins, Wolters Kluwer, and World Scientific Publishing. Ms Walker and Dr Miller report no potential conflict of interest.