A new trial design to accelerate tuberculosis drug development: The Phase IIC Selection Trial with Extended Posttreatment follow-up (STEP)

BMC Medicine

Volumn 14, Issue 1, 2016, Pages

  Phillips, Patrick P J ^a   Dooley, Kelly E ^b   Gillespie, Stephen H ^c   Heinrich, Norbert ^d,e   Stout, Jason E ^f   Nahid, Payam ^g   Diacon, Andreas H ^h,i   Aarnoutse, Rob E ^j   Kibiki, Gibson S ^k   Boeree, Martin J ^j   Hoelscher, Michael ^d,e  

^a UNIVERSITY COLLEGE LONDON   (United Kingdom)

^b JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF ST ANDREWS   (United Kingdom)

^d LUDWIG MAXIMILIANS UNIVERSITY   (Germany)

^e Partner Site Munich   (Germany)

^f DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^g UNIVERSITY OF CALIFORNIA   (United States)

^h STELLENBOSCH UNIVERSITY   (South Africa)

ⁱ TASK APPLIED SCIENCE   (South Africa)

^j RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^k East African Community   (Tanzania)

more..

Author keywords

Clinical trials; Drug development; Middle development; Phase IIC; Regimen development; STEP; Tuberculosis

Indexed keywords

TUBERCULOSTATIC AGENT;

ARTICLE; BAYESIAN LEARNING; CLINICAL PROTOCOL; CLINICAL RESEARCH; CONCEPTUAL FRAMEWORK; CONTROLLED STUDY; DECISION MAKING; DRUG EFFICACY; DRUG SAFETY; FOLLOW UP; HUMAN; MAJOR CLINICAL STUDY; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL; PROBABILITY; SIMULATION; TUBERCULOSIS; BAYES THEOREM; CLINICAL TRIAL; DRUG DEVELOPMENT; FEMALE; METHODOLOGY; PHASE 3 CLINICAL TRIAL; PROCEDURES; RANDOMIZED CONTROLLED TRIAL;

BAYES THEOREM; DRUG DISCOVERY; FEMALE; HUMANS; RESEARCH DESIGN; TUBERCULOSIS;

EID: 85007449465     PISSN: None     EISSN: 17417015     Source Type: Journal    
DOI: 10.1186/s12916-016-0597-3     Document Type: Article

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