THANK YOU FOR JOINING ISMPP U TODAY!

Transcription

1 THANK YOU FOR JOINING ISMPP U TODAY! The program will begin promptly at 11:00 am eastern January 31, 2013

2 2 ISMPP WOULD LIKE TO THANK.. the following Corporate Platinum Sponsors for their ongoing support of the society

3 3 ISMPP ANNOUNCEMENTS 9 th Annual Meeting of ISMPP Registration is now open. Early bird pricing is good through March 24 th Exhibit and Sponsorship opportunities are now available. For more information, visit ismpp.org Call for Abstracts for the 9 th Annual Meeting is closing tomorrow. Submission deadline is Friday, February 1 st at 5:00pm EST This program qualifies for 1 credit towards recertification CMPP applications are now electronic! Submit yours for the March 2013 exam by February 15 th

4 PUBLISHING INDUSTRY-SPONSORED STUDIES IN PEER-REVIEWED JOURNALS: ARE MORE RESTRICTIONS THE WAVE OF THE FUTURE? January 31, 2013

5 INTRODUCTIONS Faculty: Fiona Godlee has been Editor-in-Chief of the BMJ since She qualified as a doctor in 1985, trained as a general physician in Cambridge and London, and is a Fellow of the Royal College of Physicians. Since joining the BMJ in 1990 she has written on a broad range of issues, including the impact of environmental degradation on health, the future of the World Health Organisation, the ethics of academic publication, and the problems of editorial peer review. In 1994 she spent a year at Harvard University as a Harkness Fellow evaluating efforts to bridge the gap between medical research and practice. On returning to the UK, she led the development of BMJ Clinical Evidence, which evaluates the best available evidence on the benefits and harms of treatments and is now provided worldwide to over a million clinicians in 9 languages. In 2000 she moved to Current Science Group to establish the open access online publisher BioMed Central as Editorial Director for Medicine. In 2003 she returned to the BMJ Group to head up its new Knowledge division. She has served as President of the World Association of Medical Editors (WAME) and Chair of the Committee on Publication Ethics (COPE) and is co-editor of Peer Review in Health Sciences. 5

6 INTRODUCTIONS Faculty: Christine Laine is Editor-in-Chief of Annals of Internal Medicine. She is board-certified in internal medicine and remains active in patient care and teaching at Jefferson Medical College in the Division of Internal Medicine. Dr. Laine first joined Annals of Internal Medicine in June 1995 as an Associate Editor and became a Deputy Editor in 1998 and Senior Deputy Editor in April In July 2009, Dr. Laine became the Editor and a Senior Vice President at the American College of Physicians. Dr. Laine is active in the world of medical journalism and holds leadership positions in the International Committee of Medical Journal Editors, the Council of Science Editors, and the Ethics committee of the World Association of Medical Editors. She has been instrumental in the development of editorial policy about issues such as authorship, conflicts of interest, and data sharing in medical research. 6

7 INTRODUCTIONS Faculty: Daniel Haller received his M.D. from the University of Pittsburgh and joined the faculty of the University of Pennsylvania in Since 1993, he has served as Professor of Medicine. His chief areas of clinical research are in the management of gastrointestinal malignancies. He was honored by being named Outstanding Clinical Specialist by his peers at Penn in 2004, and was awarded the Deenie Greitzer Gastrointestinal Medical Oncology Professorship in He has also been awarded the Distinguished Achievement Award from ASCO. For 18 years, Dr. Haller was the Associate Editor for Hematology-Oncology of the Annals of Internal Medicine and was also the Editor-in-Chief of PDQ, the National Cancer Institute s cancer information database. From , Dr. Haller served as Editor-in-Chief of the Journal of Clinical Oncology, the official journal of the American Society of Clinical Oncology, and is now Editor-in-Chief of the ISGIO official journal Gastrointestinal Cancer Research and co-editor of the 3 rd Edition of the Oxford Textbook of Oncology. He is the author or co-author of more than 150 peer-reviewed publications. 7

8 8 INTRODUCTIONS Session Leader: Neil Adams has worked in medical publishing for the past 15 years at companies such as John Wiley & Sons, Springer Science & Business Media and Informa Healthcare. He is currently publishing manager for the Pharma Solutions division at Nature Publishing Group (NPG), where he works with pharmaceutical and medical communications companies, lead investigators and medical journal editors to publish clinical studies in NPG journals. Neil is an active member of ISMPP, currently serving on its ISMPP U committee and also has served as a workshop faculty member, most recently for the 2013 European Meeting of ISMPP. Moderator: Tom Drake is Vice President, Business Development with The JB Ashtin Group, Inc. He has been involved in global pharmaceutical marketing, and supported strategic medical communications and publication planning for over 20 years. Tom is an ISMPP Certified Medical Publication Professional TM (CMPP) and a member of the ISMPP-U and the ISMPP Annual Meeting committees.

9 9 DISCLOSURES Information presented reflects our personal knowledge and opinion and does not represent those of our current or past employers or those of the ISMPP

10 10 TODAY S OBJECTIVES At the end of this session, attendees should be able to: Discuss past and current journal policies regarding the publication of clinical trial data Describe and discuss implications of these policies as they relate to industry-sponsored studies

11 11 WHY THIS WEBINAR? WHY ARE WE HERE? The British Medical Journal (BMJ) announced that as of January 2013, it will no longer publish the results of clinical trials unless drug companies and researchers agree to provide detailed study data on request. The New York Times, p. B7, Nov. 1, 2012

12 12 WHY THIS WEBINAR? WHY ARE WE HERE? New BMJ policy (details still to be determined): Authors would have to promise to release patient-level trial data to researchers who made a reasonable request. Journal would publicize instances in which requests were rejected. BMJ Editor, Fiona Godlee, hopes that other major journals will follow suit. We expect that eventually this will become the norm.

13 13 OTHER RESTRICTIONS (REQUIREMENTS) HAVE BEEN IMPOSED IN THE PAST JAMA introduced a new policy in July 2005 All industry-sponsored studies must undergo independent analysis by statisticians at academic institutions Rumored that some pharma companies would boycott the journal Editorial, JAMA, Vol. 294, No. 1, p.110 (July 6, 2005) 2005 American Medical Association.

14 14 FOLLOW-UP STUDY TO JAMA REQUIREMENT PUBLISHED IN 2010 As a result of this new requirement, JAMA published significantly fewer industry-funded RCTs However, industry-funded RCTs increased significantly at both NEJM and The Lancet during the same time period Wager E, Mhaskar R, Warburton S, Djulbegovic B (2010) JAMA Published Fewer Industry-Funded Studies after Introducing a Requirement for Independent Statistical Analysis. PLoS ONE 5(10): e doi: /journal.pone

15 COMMERCIALLY FUNDED RCT PUBLICATIONS PRE- AND POST JAMA S INDEPENDENT STATISTICAL ANALYSIS POLICY Number of randomized controlled trials (RCTs) and studies with commercial funding published in JAMA, NEJM and The Lancet in the 3 years before and after JAMA's policy on independent statistical analysis (July 2005). Wager E, Mhaskar R, Warburton S, Djulbegovic B (2010) JAMA Published Fewer Industry-Funded Studies after Introducing a Requirement for Independent Statistical Analysis. PLoS ONE 5(10): e doi: /journal.pone

16 COMMERCIALLY FUNDED RCT PUBLICATIONS PRE- AND POST JAMA S INDEPENDENT STATISTICAL ANALYSIS POLICY RCTs Published with any type of Commercial Funding Pre-Policy Post-Policy JAMA NEJM Lancet Adapted from Wager E, Mhaskar R, Warburton S, Djulbegovic B (2010) JAMA Published Fewer Industry-Funded Studies after Introducing a Requirement for Independent Statistical Analysis. PLoS ONE 5(10): e doi: /journal.pone

17 17 JAMA S POLICY ON INDEPENDENT STATISTICAL ANALYSIS As of October 2010, policy not adopted by other major journals. Has it been adopted by other major journals since then? Criticized by some statisticians (see Rothman KJ and Evans S, Extra Scrutiny for Industry Funded Trials, BMJ 331: ; 2005). Did it achieve its goal?

18 RCTs AND WHAT IS THE SITUATION IN 2012? Number of RCTs and studies with commercial funding published in JAMA during last 3 years vs. 3 years before and 3 years after policy on independent statistical analysis All RCTs RCTs with Commercial Funding Data derived from an informal PubMed search of RCTs published in JAMA from

19 IN 2005, OTHER RESTRICTIONS ALSO APPEARED Editorial (March, 2005) -- We will no longer consider for publication in regular monthly issues of the CCJM any review article in which a manufacturer played a part in the preparation of the manuscript, either directly or through payment to the author or a surrogate. From the Editor, CCJM, Vol. 72, No. 3, p.169 (March, 2005) 19

20 20 CCJM POLICY (cont d) However We will continue to consider articles written by experts who declare relationships with companies, such as accepting research grants or serving as consultants. Such experts often know the most about new devices and drugs. From the Editor, CCJM, Vol. 72, No. 3, p.169 (March, 2005)

21 MEANWHILE, AT THE NEJM LAST YEAR For the past 18 months, we have been posting study protocols to accompany published articles about randomized, controlled trials to provide a better definition of each trial s study design. NEJM Editorial, Vol. 367, pp (September 20, 2012) 21

22 FACULTY QUESTIONS

23 23 QUESTIONS FOR DR. LAINE AND DR. HALLER Do you expect -- like Dr. Godlee -- that it will become the norm for major journals to require pharma companies and researchers to provide detailed study data on request as a condition for publishing their studies? If so, do you think pharma companies will provide this data or submit to lower-profile journals instead?

24 24 QUESTIONS FOR THE ENTIRE FACULTY Is it likely that in the future we will see restrictions imposed by more peer-reviewed journals for publishing industry-sponsored studies? What other restrictions, if any, will be imposed?

25 25 QUESTIONS FOR THE ENTIRE FACULTY NEJM Editorial (Sept. 20, 2012): Believe the Data A trial s validity should ride on the study design, the quality of dataaccrual and analytic processes, and the fairness of results reporting. Ideally, these factors not the funding source should be the criteria for deciding the clinical utility. (Vol. 367, pp ). Do you agree? If so, why are these restrictions necessary?

26 QUESTIONS? To ask a question, please type your query into the Q&A chat box at the bottom left of your screen. Every attempt will be made to answer all questions.

27 THANK YOU

28 28 UPCOMING ISMPP U TOPICS Stay tuned for the upcoming ISMPP U topics dates to be announced shortly Part II of our Challenging Cases series (February) ISMPP Tools You Can Use (March)

29 29 THANK YOU FOR ATTENDING! We hope you enjoyed today's presentation Please take a moment to fill out the survey sent to you after today s program so you can provide valuable feedback, as it will help us to develop future educational offerings