The web of clinical trial registration obligations: have foreign clinical trials been caught?
The web of overlapping requirements, standards, recommendations and policies governing the conduct of clinical trials highlights the intense scrutiny of the ethical, data quality and public access issues raised by human trials that are conducted to demonstrate the safety and efficacy of medical products marketed in the United States. One relatively recent development is the requirement that sponsors register and make public information about their clinical trials and clinical trial results. These clinical trial registration requirements illustrate the interests of patients, providers and researchers in increased visibility, transparency and accessibility of clinical trials and the data they generate. These requirements, however, pose regulatory, logistical and practical hurdles for companies sponsoring clinical trials of drugs and medical devices.
Hathaway
Carolyne R
CR
Latham & Watkins LLP, Washington, DC, USA.
Manthei
John R
JR
Haas
J Ben
JB
Meltzer
Elizabeth D
ED
D002568:Certification / Q000331:legislation & jurisprudence / Q000592:standards; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000592:standards; D003132:Commerce / Q000331:legislation & jurisprudence; D019992:Databases as Topic / Q000331:legislation & jurisprudence* / Q000592:standards; D018795:Device Approval; D017277:Drug Approval; D033161:Government Regulation; D006801:Humans; D007390:International Agencies / Q000331:legislation & jurisprudence*; D007391:International Cooperation / Q000331:legislation & jurisprudence*; D020407:Internet; D017387:Investigational New Drug Application / Q000331:legislation & jurisprudence; D037141:Mandatory Programs / Q000331:legislation & jurisprudence*; D019221:Mandatory Reporting; D011642:Publications; D012042:Registries / Q000592:standards*; D012957:Societies, Pharmaceutical; D014481:United States; D014486:United States Food and Drug Administration; D035141:Voluntary Programs