Abbott A. Novartis to shut brain research facility. Nature. 2011;480(7376):161–162. [PubMed: 22158218]

Aggarwal SP, Zinman L, Simpson E, McKinley J, Jackson KE, Pinto H, Conwit RA, Schoenfeld D, Shefner J, Cudkowicz M. Clinical trial testing lithium in ALS terminates early for futility. Lancet Neurology. 2010;9(5):481. [PMC free article: PMC3071495] [PubMed: 20363190]

Alvir JM, Lieberman JA, Safferman AZ, Schwimmer JL, Schaaf JA. Clozapine-induced agranulocytosis. Incidence and risk factors in the United States. New England Journal of Medicine. 1993;329(3):162–167. [PubMed: 8515788]

American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 5th ed. Washington, DC: American Psychiatric Publishing; 2013.

Anglemyer A, Horvath HT, Bero L. Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials. Cochrane Database of Systematic Reviews. 2014;4(MR000034) [PMC free article: PMC8191367] [PubMed: 24782322]

Arrowsmith J, Miller P. Trial watch: Phase II and Phase III attrition rates 2011-2012. Nature Reviews Drug Discovery. 2013;12(8):569. [PubMed: 23903212]

Becker RE, Greig NH. Neuropsychiatric clinical trials: Should they accommodate real-world practices or set standards for clinical practices? Journal of Clinical Psychopharmacology. 2009;29(1):56–64. [PMC free article: PMC3727422] [PubMed: 19142109]

Benson K, Hartz AJ. A comparison of observational studies and randomized, controlled trials. New England Journal of Medicine. 2000;342(25):1878–1886. [PubMed: 10861324]

Berndt ER, Cockburn IM. Monthly Labor Review: U.S. Bureau of Labor Statistics. 2014. (Price indexes for clinical trial research: A feasibility study. No. w18918).

Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework. Clinical Pharmacology & Therapeutics. 2001;69(3):89–95. [PubMed: 11240971]

Bleck T, Cock H, Chamberlain J, Cloyd J, Connor J, Elm J, Fountain N, Jones E, Lowenstein D, Shinnar S, Silbergleit R, Treiman D, Trinka E, Kapur J. The established status epilepticus trial 2013. Epilepsia. 2013;5(s6):89–92. [PMC free article: PMC4048827] [PubMed: 24001084]

Borsboom D, Cramer AO. Network analysis: An integrative approach to the structure of psychopathology. Annual Review of Clinical Psychology. 2013;9:91–121. [PubMed: 23537483]

Buckholtz JW, Meyer-Lindenberg A. Psychopathology and the human connectome: Toward a transdiagnostic model of risk for mental illness. Neuron. 2012;74(6):990–1004. [PubMed: 22726830]

Button KS, Ioannidis JP, Mokrysz C, Nosek BA, Flint J, Robinson ES, Munafo MR. Power failure: Why small sample size undermines the reliability of neuroscience. Nature Reviews Neuroscience. 2013;14(5):365–376. [PubMed: 23571845]

Cai N, Bigdeli TB, Kretzschmar W, Li Y, Liang J, Song L, Hu J, Li Q, Jin W, Hu Z, Wang G. Sparse whole-genome sequencing identifies two loci for major depressive disorder. Nature. 2015;523(7562):588–591. [PMC free article: PMC4522619] [PubMed: 26176920]

Capone M. Venture Beat. 2015. [June 3, 2016]. (How wearables and mobile health tech are reshaping clinical trials). http://venturebeat​.com​/2015/04/17/how-wearables-and-mobile-health-tech-are-reshaping-clinic.

Casey BJ, Craddock N, Cuthbert BN, Hyman SE, Lee FS, Ressler KJ. DSM-5 and RDoC: Progress in psychiatry research? Nature Reviews Neuroscience. 2013;14(11):810–814. [PMC free article: PMC4372467] [PubMed: 24135697]

Chassang S, Snowberg E, Seymour B, Bowles C. Accounting for behavior in treatment effects: New applications for blind trials. PLoS ONE. 2015;10(6):e0127227. [PMC free article: PMC4465691] [PubMed: 26062024]

Chen-Plotkin AS. Unbiased approaches to biomarker discovery in neurodegenerative diseases. Neuron. 2014;84(3):594–607. [PMC free article: PMC4254637] [PubMed: 25442938]

Clark CM, Schneider JA, Bedell BJ, Beach TG, Bilker WB, Mintun MA, Pontecorvo MJ, Hefti F, Carpenter AP, Flitter ML, Krautkramer MJ. Use of florbetapir-PET for imaging β-amyloid pathology. Journal of the American Medical Association. 2011;305(3):275–283. [PMC free article: PMC7041965] [PubMed: 21245183]

Cohen PD, Herman L, Jedlinski S, Willocks P, Wittekind P. Ethical issues in clinical neuroscience research: A patient's perspective. Neurotherapeutics. 2007;4(3):537–544. [PMC free article: PMC7479722] [PubMed: 17599719]

Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. New England Journal of Medicine. 2000;342(25):1887–1892. [PMC free article: PMC1557642] [PubMed: 10861325]

Connor JT, Elm JJ, Broglio KR., ESETT, and Adapt-It Investigators. Bayesian adaptive trials offer advantages in comparative effectiveness trials: An example in status epilepticus. Journal of Clinical Epidemiology. 2013;66(8):S130–S137. [PMC free article: PMC3743558] [PubMed: 23849147]

Cook D, Brown D, Alexander R, March R, Morgan P, Satter-thwaite G, Pangalos MN. Lessons learned from the fate of AstraZeneca's drug pipeline: A five-dimensional framework. Nature Reviews Drug Discovery. 2014;13(6):419–431. [PubMed: 24833294]

Cross-Disorder Group of the Psychiatric Genomics Consortium. Genetic relationship between five psychiatric disorders estimated from genome-wide SNPs. Nature Genetics. 2013;45(9):984–994. [PMC free article: PMC3800159] [PubMed: 23933821]

Dankar FK, El Emam K, Neisa A, Roffey T. Estimating the re-identification risk of clinical data sets. BMC Medical Informatics and Decision Making. 2012;12(1):66. [PMC free article: PMC3583146] [PubMed: 22776564]

Desgrousilliers M, Keet G. Clinical Leader. 2015. [July 27, 2016]. (How wearable electronics will change clinical trials). http://www​.clinicalleader​.com/doc/how-wearable-electronics-will-change-clinical-trials-0001.

DiMasi JA, Grabowski HG. The cost of biopharmaceutical R&D: Is biotech different? Managerial and Decision Economics. 2007;28(4-5):469–479.

Dorsey ER, Wagner JD, Bull MT, Rizzieri A, Grischkan J, Achey MA, Sherer T, Chowdhury S, Meunier C, Cappelletti L, Rocker C, Richard IH, Schwarz H, Kang G, Ahmad SH, Biemiller RA, Biglan KM. Feasibility of virtual research visits in Fox Trial Finder. Journal of Parkinson's Disease. 2015;5(3):505–515. [PMC free article: PMC4923707] [PubMed: 26406130]

Eguale T, Buckeridge DL, Verma A, Winslade NE, Benedetti A, Hanley JA, Tamblyn R. Association of off-label drug use and adverse drug events in an adult population. Journal of the American Medical Association Internal Medicine. 2016;176(1):55–63. [PubMed: 26523731]

Ereshefsky L, Evans R, Sood R, Williamson D, English BA. Venturing into a new era of CNS drug development to improve success. Waltham, MA: Parexel; 2016. [June 22, 2016]. https://www​.parexel.com​/files/4314/4113/4032​/Venturing_Into_a​_New_Era_of_CNS_Drug​_Development_to_Improve_Success.pdf.

Ferrario A, Kanavos P. Dealing with uncertainty and high prices of new medicines: A comparative analysis of the use of managed entry agreements in Belgium, England, the Netherlands and Sweden. Social Science & Medicine. 2015;124:39–47. [PubMed: 25461860]

Flaherty KT, Infante JR, Daud A, Gonzalez R, Kefford RF, Sosman J, Hamid O, Schuchter L, Cebon J, Ibrahim N, Kudchadkar R, Burris HA 3rd, Falchook G, Algazi A, Lewis K, Long GV, Puzanov I, Lebowitz P, Singh A, Little S, Sun P, Allred A, Ouellet D, Kim KB, Patel K, Weber J. Combined BRAF and MEK inhibition in melanoma with BRAF V600 mutations. New England Journal of Medicine. 2012;367(18):1694–1703. [PMC free article: PMC3549295] [PubMed: 23020132]

Fornai F, Longone P, Cafaro L, Kastsiuchenka O, Ferrucci M, Manca ML, Lazzeri G, Spalloni A, Bellio N, Lenzi P, Modugno N, Siciliano G, Isidoro C, Murri L, Ruggieri S, Paparelli A. Lithium delays progression of amyotrophic lateral sclerosis. Proceedings of the National Academy of Sciences of the United States of America. 2008;105(6):2052–2057. [PMC free article: PMC2538879] [PubMed: 18250315]

Fournier JC, DeRubeis RJ, Hollon SD, Dimidjian S, Amsterdam JD, Shelton RC, Fawcett J. Antidepressant drug effects and depression severity: A patient-level meta-analysis. Journal of the American Medical Association. 2010;303(1):47–53. [PMC free article: PMC3712503] [PubMed: 20051569]

Fried EI, Epskamp S, Nesse RM, Tuerlinckx F, Borsboom D. What are “good” depression symptoms? Comparing the centrality of DSM and non-DSM symptoms of depression in a network analysis. Journal of Affective Disorders. 2016;189:314–320. [PubMed: 26458184]

Glickman SW, Galhenage S, McNair L, Barber Z, Patel K, Schulman KA, McHutchison JG. The potential influence of Internet-based social networking on the conduct of clinical research studies. Journal of Empirical Research on Human Research Ethics. 2012;7(1):71–80. [PubMed: 22378136]

Goodkind M, Eickhoff SB, Oathes DJ, Jiang Y, Chang A, Jones-Hagata LB, Ortega BN, Zaiko YV, Roach EL, Korgaonkar MS, Grieve SM, Galatzer-Levy I, Fox PT, Etkin A. Identification of a common neurobiological substrate for mental illness. Journal of the American Medical Association Psychiatry. 2015;72(4):305–315. [PMC free article: PMC4791058] [PubMed: 25651064]

Gordon D, Taddei-Peters W, Mascette A, Antman M, Kaufmann PG, Lauer MS. Publication of trials funded by the National Heart, Lung, and Blood Institute. New England Journal of Medicine. 2013;369(20):1926–1934. [PMC free article: PMC3928673] [PubMed: 24224625]

Greene SM, Reid RJ, Larson EB. Implementing the learning health system: From concept to action. Annals of Internal Medicine. 2012;157(3):207–210. [PubMed: 22868839]

Gupta S. Patient recruitment and retention are major challenges for clinical trials in CNS. Applied Clinical Trials. 2012;21(1) [July 27, 2016]; http://www​.appliedclinicaltrialsonline​.com​/patient-recruitment-and-retention-are-major-challenges-clinicaltrials-cns.

GUSTO Investigators. The effects of tissue plasminogen activator, streptokinase, or both on coronary-artery patency, ventricular function, and survival after acute myocardial infarction. The GUSTO Angiographic Investigators. New England Journal of Medicine. 1993;329(22):1615–1622. [PubMed: 8232430]

Haslam N, Holland E, Kuppens P. Categories versus dimensions in personality and psychopathology: A quantitative review of taxometric research. Psychological Medicine. 2012;42(5):903–920. [PubMed: 21939592]

Hedden T, Van Dijk KR, Becker JA, Mehta A, Sperling RA, Johnson KA, Buckner RL. Disruption of functional connectivity in clinically normal older adults harboring amyloid burden. The Journal of Neuroscience. 2009;29(40):12686–12694. [PMC free article: PMC2808119] [PubMed: 19812343]

Hernandez AF, O'Connor CM, Starling RC, Reist CJ, Armstrong PW, Dickstein K, Lorenz TJ, Gibler WB, Hasselblad V, Komajda M, Massie B. Rationale and design of the acute study of clinical effectiveness of nesiritide in decompensated heart failure trial (ASCEND-HF). American Heart Journal. 2009;157(2):271–277. [PubMed: 19185633]

Herper M. Forbes. Feb 11, 2015. [June 22, 2016]. (The coming boom in brain medicines). http://www​.forbes.com​/sites/matthewherper​/2015/02/11/brain-boom-the-drugcompanies-bringing-neuroscience-back-from-the-brink/#7247c0d352a2.

Insel TR, Cuthbert BN. Brain disorders? Precisely. Science. 2015;348(6234):499–500. [PubMed: 25931539]

IOM (Institute of Medicine). Sharing clinical trial data: Maximizing benefits, minimizing risk. Washington, DC: The National Academies Press; 2015. [PubMed: 25590113]

Kaitin KI. Pace of CNS drug development and FDA approvals lags other drug classes. Tufts Center for the Study of Drug Development Impact Report. 2012;14(2)

Kang JH, Irwin DJ, Chen-Plotkin AS, Siderowf A, Caspell C, Coffey CS, Waligorska T, Taylor P, Pan S, Frasier M, Marek K, Kieburtz K, Jennings D, Simuni T, Tanner CM, Singleton A, Toga AW, Chowdhury S, Mollenhauer B, Trojanowski JQ, Shaw LM., Parkinson's Progression Markers Initiative. Association of cerebrospinal fluid beta-amyloid 1-42, T-tau, P-tau181, and alpha-synuclein levels with clinical features of drug-naive patients with early Parkinson disease. Journal of the American Medical Association Neurology. 2013;70(10):1277–1287. [PMC free article: PMC4034348] [PubMed: 23979011]

Kendler KS. The phenomenology of major depression and the representativeness and nature of DSM criteria. American Journal of Psychiatry. 2016;173(8):771–780. [PubMed: 27138588]

Kendler KS, Aggen SH, Knudsen GP, Roysamb E, Neale MC, Reichborn-Kjennerud T. The structure of genetic and environmental risk factors for syndromal and subsyndromal common DSM-IV axis I and all axis II disorders. American Journal of Psychiatry. 2011;168(1):29–39. [PMC free article: PMC3126864] [PubMed: 20952461]

Kesselheim AS, Hwang TJ, Franklin JM. Two decades of new drug development for central nervous system disorders. Nature Reviews Drug Discovery. 2015;14(12):815–816. [PubMed: 26585536]

Kumar S, Nilsen WJ, Abernethy A, Atienza A, Patrick K, Pavel M, Riley WT, Shar A, Spring B, Spruijt-Metz D, Hedeker D, Honavar V, Kravitz R, Lefebvre RC, Mohr DC, Murphy SA, Quinn C, Shusterman V, Swendeman D. Mobile health technology evaluation: The mHealth evidence workshop. American Journal of Preventative Medicine. 2013;45(2):228–236. [PMC free article: PMC3803146] [PubMed: 23867031]

Lahey BB, Van Hulle CA, Singh AL, Waldman ID, Rathouz PJ. Higher-order genetic and environmental structure of prevalent forms of child and adolescent psychopathology. Archives of General Psychiatry. 2011;68(2):181–189. [PMC free article: PMC3322461] [PubMed: 21300945]

Lauer MS, D'Agostino RB Sr. The randomized registry trial—the next disruptive technology in clinical research? New England Journal of Medicine. 2013;369(17):1579–1581. [PubMed: 23991657]

Levine SZ, Rabinowitz J, Uher R, Kapur S. Biomarkers of treatment outcome in schizophrenia: Defining a benchmark for clinical significance. European Neuropsychopharmacology. 2015;25(10):1578–1585. [PubMed: 26145487]

Lillie EO, Patay B, Diamant J, Issell B, Topol EJ, Schork NJ. The n-of-1 clinical trial: The ultimate strategy for individualizing medicine? Personalized Medicine. 2011;8(2):161–173. [PMC free article: PMC3118090] [PubMed: 21695041]

Liu Q, Jamba M, Patrick C III, Padmanabhan S, Brennan MD. Targeted pharmacogenetic analysis of antipsychotic response in the CATIE study. Pharmacogenomics. 2012;13(11):1227–1237. [PMC free article: PMC3518380] [PubMed: 22920393]

Meurer WJ, Lewis RJ. Cluster randomized trials: Evaluating treatments applied to groups. Journal of the American Medical Association. 2015;313(20):2068–2069. [PubMed: 26010636]

Miller G. Is pharma running out of brainy ideas? Science. 2010;329(5991):502–504. [PubMed: 20671165]

Milliman, Inc. Milliman Specialty Medication Benchmark Study, 2013 analysis of 2011 data. Brookfield, WI: Millman, Inc; 2013.

Montilla S, Marchesini G, Sammarco A, Trotta MP, Siviero PD, Tomino C, Melchiorri D, Pani L., AIFA Anti-diabetics Monitoring Group. Drug utilization, safety, and effectiveness of exenatide, sitagliptin, and vildagliptin for type 2 diabetes in the real world: Data from the Italian AIFA Anti-diabetics Monitoring Registry. Nutrition, Metabolism and Cardiovascular Diseases. 2014;24(12):1346–1353. [PubMed: 25300980]

Montilla S, Xoxi E, Russo P, Cicchetti A, Pani L. Monitoring registries at Italian Medicines Agency: Fostering access, guaranteeing sustainability. International Journal of Technology Assessment in Health Care. 2015;31(4):210–213. [PubMed: 26646859]

Nelson MR, Tipney H, Painter JL, Shen J, Nicoletti P, Shen Y, Floratos A, Sham PC, Li MJ, Wang J, Cardon LR, Whittaker JC, Sanseau P. The support of human genetic evidence for approved drug indications. Nature Genetics. 2015;47(8):856–860. [PubMed: 26121088]

Pammolli F, Magazzini L, Riccaboni M. The productivity crisis in pharmaceutical R&D. Nature Reviews Drug Discovery. 2011;10(6):428–438. [PubMed: 21629293]

Pankevich DE, Altevogt BM, Dunlop J, Gage FH, Hyman SE. Improving and accelerating drug development for nervous system disorders. Neuron. 2014;84(3):546–553. [PMC free article: PMC4254615] [PubMed: 25442933]

Parekh A, Buckman-Garner S, McCune S, Neill R O, Geanacopoulos M, Amur S, Clingman C, Barratt R, Rocca M, Hills I, Woodcock J. Catalyzing the Critical Path Initiative: FDA's progress in drug development activities. Clinical Pharmacology & Therapeutics. 2015;97(3):221–233. [PubMed: 25670629]

Prata D, Mechelli A, Kapur S. Clinically meaningful biomarkers for psychosis: A systematic and quantitative review. Neuroscience and Biobehavioral Reviews. 2014;45:134–141. [PubMed: 24877683]

Purgato M, Barbui C, Stroup S, Adams C. Pragmatic design in randomized controlled trials. Psychological Medicine. 2015;45(2):225–230. [PubMed: 25065958]

Qiang JK, Wong YC, Siderowf A, Hurtig HI, Xie SX, Lee VM, Trojanowski JQ, Yearout D, Leverenz J B, Montine TJ, Stern M, Mendick S, Jennings D, Zabetian C, Marek K, Chen-Plotkin AS. Plasma apolipoprotein A1 as a biomarker for Parkinson disease. Annals of Neurology. 2013;74(1):119–127. [PMC free article: PMC3773265] [PubMed: 23447138]

Ranganathan P, Pramesh CS, Buyse M. Common pitfalls in statistical analysis: Clinical versus statistical significance. Perspectives in Clinical Research. 2015;6(3):169–170. [PMC free article: PMC4504060] [PubMed: 26229754]

Riordan H, Cutler N. The death of CNS drug development: Overstatement or omen. Journal of Clinical Studies. 2011;3(6):12–15.

Rosenthal LS, Drake D, Alcalay RN, Babcock D, Bowman FD, Chen-Plotkin A, Dawson TM, Dewey RB Jr., German DC, Huang X, Landin B, McAuliffe M, Petyuk VA, Scherzer CR, Hillaire-Clarke CS, Sieber BA, Sutherland M, Tarn C, West A, Vaillancourt D, Zhang J, Gwinn K. The NINDS Parkinson's disease biomarkers program. Movement Disorders. 2015;31:915–923. on behalf of the PDBP Consortium. [PMC free article: PMC4824671] [PubMed: 26442452]

Rzhetsky A, Wajngurt D, Park N, Zheng T. Probing genetic overlap among complex human phenotypes. Proceedings of the National Academy of Sciences of the United States of America. 2007;104(28):11694–11699. [PMC free article: PMC1906727] [PubMed: 17609372]

Sarpal DK, Robinson DG, Lencz T, Argyelan M, Ikuta T, Karlsgodt K, Gallego JA, Kane JM, Szeszko PR, Malhotra AK. Antipsychotic treatment and functional connectivity of the striatum in first-episode schizophrenia. Journal of the American Medical Association Psychiatry. 2015;72(1):5–13. [PMC free article: PMC4286512] [PubMed: 25372846]

Sarpal DK, Argyelan M, Robinson DG, Szeszko PR, Karlsgodt KH, John M, Weissman N, Gallego JA, Kane JM, Lencz T, Malhotra AK. Baseline striatal functional connectivity as a predictor of response to antipsychotic drug treatment. American Journal of Psychiatry. 2016;173(1):69–77. [PMC free article: PMC4845897] [PubMed: 26315980]

Shaw LM, Vanderstichele H, Knapik-Czajka M, Clark CM, Aisen PS, Petersen RC, Blennow K, Soares H, Simon A, Lewczuk P, Dean R, Siemers E, Potter W, Lee VM, Trojanowski JQ., Alzheimer's Disease Neuroimaging Initiative. Cerebrospinal fluid biomarker signature in Alzheimer's Disease Neuroimaging Initiative subjects. Annals of Neurology. 2009;65(4):403–413. [PMC free article: PMC2696350] [PubMed: 19296504]

Silberman S. Placebos are getting more effective. Drugmakers are desperate to know why. WIRED Magazine. 2009 [July 27, 2009]; http://archive​.wired​.com/medtech/drugs/magazine​/17-09/ff_placebo​_effect?currentPage=all.

Slamon DJ, Clark GM, Wong SG, Levin WJ, Ullrich A, McGuire WL. Human breast cancer: Correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science. 1987;235(4785):177–182. [PubMed: 3798106]

Smith I, Procter M, Gelber RD, Guillaume S, Feyereislova A, Dowsett M, Goldhirsch A, Untch M, Mariani G, Baselga J, Kaufmann M, Cameron D, Bell R, Bergh J, Coleman R, Wardley A, Harbeck N, Lopez RI, Mallmann P, Gelmon K, Wilcken N, Wist E, Sanchez Rovira P, Piccart-Gebhart MJ., Hera study team. 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: A randomised controlled trial. Lancet. 2007;369(9555):29–36. [PubMed: 17208639]

Sperling RA, Aisen PS, Beckett LA, Bennett DA, Craft S, Fagan AM, Iwatsubo T, Jack CR Jr., Kaye J, Montine TJ, Park DC, Reiman EM, Rowe CC, Siemers E, Stern Y, Yaffe K, Carrillo MC, Thies B, Morrison-Bogorad M, Wagster MV, Phelps CH. Toward defining the preclinical stages of Alzheimer's disease: Recommendations from the National Institute on Aging‒Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimer's & Dementia. 2011;7(3):280–292. [PMC free article: PMC3220946] [PubMed: 21514248]

Strom BL, Buyse M, Hughes J, Knoppers BM. Data sharing, year 1—access to data from industry-sponsored clinical trials. New England Journal of Medicine. 2014;371(22):2052–2054. [PubMed: 25317745]

Swanson CR, Berlyand Y, Xie SX, Alcalay RN, Chahine LM, Chen-Plotkin AS. Plasma apolipoprotein A1 associates with age at onset and motor severity in early Parkinson's disease patients. Movement Disorders. 2015;30(12):1648–1656. [PMC free article: PMC4609229] [PubMed: 26207725]

Taichman DB, Backus J, Baethge C, Bauchner H, de Leeuw PW, Drazen JM, Fletcher J, Frizelle FA, Groves T, Haileamlak A, James A, Laine C, Peiperl L, Pinborg A, Sahni P, Wu S. Sharing clinical trial data: A proposal from the International Committee of Medical Journal Editors. New England Journal of Medicine. 2016;374(4):384–386. [PubMed: 26786954]

TCSDD (Tufts Center for the Study of Drug Development). Cost of developing a new drug. 2014. [June 3, 2016]. http://csdd​.tufts.edu​/files/uploads/Tufts​_CSDD_briefing_on_RD​_cost_study_-_Nov_18,_2014.pdf.

TCSDD. High turnover, protocol noncompliance plaque the global site landscape. Tufts Center for the Study of Drug Development Impact Report. 2015;17(1)

Tracy H. CNS funds raised 2014. NeuroPerspective. 2015;230/231(4)

Uher R, Tansey KE, Malki K, Perlis RH. Biomarkers predicting treatment outcome in depression: What is clinically significant? Pharmacogenomics. 2012;13(2):233–240. [PMC free article: PMC3566553] [PubMed: 22256872]

U.S. National Library of Medicine. FAQ: ClinicalTrials.gov—clinical trial phases. 2008. [June 6, 2016]. https://www​.nlm.nih.gov​/services/ctphases.html.

Van Snellenberg JX, Torres IJ, Thornton AE. Functional neuroimaging of working memory in schizophrenia: Task performance as a moderating variable. Neuropsychology. 2006;20(5):497–510. [PubMed: 16938013]

Vitiello B. Practical clinical trials in psychopharmacology: A systematic review. Journal of Clinical Psychopharmacology. 2015;35(2):178–183. [PMC free article: PMC4427905] [PubMed: 25679131]

Volpi S, Potkin SG, Malhotra AK, Licamele L, Lavedan C. Applicability of a genetic signature for enhanced iloperidone efficacy in the treatment of schizophrenia. Journal of Clinical Psychiatry. 2009;70(6):801–809. [PubMed: 19573479]

Vonnegut K. If this isn't nice, what is?: Advice to the young. New York: Seven Stories Press; 2013.

Wagle N, Emery C, Berger MF, Davis MJ, Sawyer A, Pochanard P, Kehoe SM, Johannessen CM, Macconaill LE, Hahn WC, Meyerson M, Garraway LA. Dissecting therapeutic resistance to RAF inhibition in melanoma by tumor genomic profiling. Journal of Clinical Oncology. 2011;29(22):3085–3096. [PMC free article: PMC3157968] [PubMed: 21383288]

Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA, Plato Investigators. Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. New England Journal of Medicine. 2009;361(11):1045–1057. [PubMed: 19717846]

Wan Z, Vorobeychik Y, Xia W, Clayton EW, Kantarcioglu M, Ganta R, Heatherly R, Malin BA. A game theoretic framework for analyzing re-identification risk. PLoS ONE. 2015;10(3):e0120592. [PMC free article: PMC4373733] [PubMed: 25807380]

Wang SJ, Hung HM, O'Neill R. Adaptive design clinical trials and trial logistics models in CNS drug development. European Neuropsychopharmacology. 2011;21(2):159–166. [PubMed: 20933373]

Wegener G, Rujescu D. The current development of CNS drug research. International Journal of Neuropsychopharmacology. 2013;16(7):1687–1693. [PubMed: 23651558]

Weiner MW, Veitch DP, Aisen PS, Beckett LA, Cairns NJ, Cedarbaum J, Donohue MC, Green RC, Harvey D, Jack CR Jr., Jagust W, Morris JC, Petersen RC, Saykin AJ, Shaw L, Thompson PM, Toga AW, Trojanowski JQ., Alzheimer's Disease Neuroimaging Initiative. Impact of the Alzheimer's Disease Neuroimaging Initiative, 2004 to 2014. Alzheimer's & Dementia. 2015;11(7):865–884. [PMC free article: PMC4659407] [PubMed: 26194320]

Wicks P, Vaughan TE, Massagli MP, Heywood J. Accelerated clinical discovery using self-reported patient data collected online and a patient-matching algorithm. Nature Biotechnology. 2011;29(5):411–414. [PubMed: 21516084]