PMID- 17907954
OWN - NLM
STAT- MEDLINE
DCOM- 20080109
LR  - 20071109
IS  - 0884-0431 (Print)
IS  - 0884-0431 (Linking)
VI  - 22
IP  - 11
DP  - 2007 Nov
TI  - Maintaining the trust of physicians and the public in the medical literature: 
      report of a task force on scientific publishing of clinical trials.
PG  - 1661-7
AB  - In 2006, the American Society of Bone and Mineral Research and the Journal of 
      Bone and Mineral Research convened a task force to consider whether and how to 
      change our editorial policies to assure complete and unbiased reporting of 
      clinical trials. We invited editors of journals that publish research on 
      osteoporosis and disorders of bone and mineral metabolism and presidents of 
      related societies to participate. The task force was charged to consider whether 
      journals should (1) adopt the Principles for Protecting Integrity in the Conduct 
      and Reporting of Clinical Trials published in 2006 by the American Association of 
      Medical Colleges (AAMC) and should (2) require authors and sponsors of 
      industry-funded clinical trials to provide a jointly signed letter that states 
      that the authors had full access to all the data and analyses on which the 
      manuscript was based. The AAMC Principles recommend that multicenter trials 
      should designate a Lead Investigator, Steering Committee, and Publication and 
      Analysis (P&A) Committee, which should consist of a majority of academic 
      investigators who are not sponsor employees. The P&A Committee should have the 
      right to access any data generated during a study and to conduct its own 
      statistical analyses. A majority of task force members voted to support the AAMC 
      Principles, to require a letter jointly signed by academic investigators and 
      industry sponsor stating that the authors had access to the data on which the 
      submission was based, and to recommend adoption of these requirements to their 
      respective societies and journals. Broad-based adoption of the AAMC Principles 
      and requirement of a jointly signed attestation of data access by journals that 
      publish clinical trials in diseases of bone and mineral metabolism should improve 
      the position of academic clinical investigators in their interactions with 
      industry and other funding sources.
FAU - Shane, Elizabeth
AU  - Shane E
AD  - Columbia University, College of Physicians & Surgeons, Department of Medicine, 
      New York, NY 10032, USA. es54@columbia.edu
FAU - Civitelli, Roberto
AU  - Civitelli R
FAU - Delmas, Pierre D
AU  - Delmas PD
FAU - Drezner, Marc
AU  - Drezner M
FAU - Eisman, John A
AU  - Eisman JA
FAU - Lindsay, Robert
AU  - Lindsay R
FAU - Lorenzo, Joseph
AU  - Lorenzo J
FAU - Miller, Paul
AU  - Miller P
FAU - Ralston, Stuart
AU  - Ralston S
FAU - Reid, Ian
AU  - Reid I
FAU - Siris, Ethel
AU  - Siris E
LA  - eng
PT  - Journal Article
PL  - England
TA  - J Bone Miner Res
JT  - Journal of bone and mineral research : the official journal of the American 
      Society for Bone and Mineral Research
JID - 8610640
SB  - IM
MH  - Advisory Committees
MH  - Clinical Trials as Topic/economics/*ethics
MH  - Conflict of Interest
MH  - *Editorial Policies
MH  - Financial Support
MH  - *Guidelines as Topic
MH  - Humans
MH  - Industry
MH  - Periodicals as Topic
MH  - Physicians
MH  - Publishing/*standards
MH  - *Trust
EDAT- 2007/10/03 09:00
MHDA- 2008/01/10 09:00
CRDT- 2007/10/03 09:00
PHST- 2007/10/03 09:00 [pubmed]
PHST- 2008/01/10 09:00 [medline]
PHST- 2007/10/03 09:00 [entrez]
AID - 10.1359/jbmr.07090c [doi]
PST - ppublish
SO  - J Bone Miner Res. 2007 Nov;22(11):1661-7. doi: 10.1359/jbmr.07090c.