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Post by akemp3000 on Mar 13, 2018 17:28:18 GMT -5
The best peer review occurred when Dr. Kendall, who is one of the premier global experts on diabetes, reviewed Mannkind's trial data and decided to leave Lilly for Afrezza and TS.
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Post by dreamboatcruise on Mar 13, 2018 17:53:45 GMT -5
Dr. Kendall served as Chief Scientific and Medical Officer at the American Diabetes Association, where he was responsible for all medical affairs, medical education, research, outcomes, and medical policy activities. “MannKind welcomes the opportunity to share the results of this collaborative clinical trial and looks forward to pursuing additional analyses to assess the clinical use of Afrezza therapy for mealtime glucose control,” stated David Kendall, MD, Chief Medical Officer of MannKind Corporation. “We believe that the STAT Study results will offer important insights into ways that individuals with diabetes can potentially improve their experience and outcomes by using mealtime inhaled insulin ’in the moment.‘ Our long-term goal is to establish inhaled human insulin as both a useful option and a potential treatment of choice for those individuals with diabetes requiring mealtime glucose control.” *Afrezza, (insulin human) In the moment. Not a big fan of the word potentially. After the STAT study I was hoping it is or it isn't. I'm assuming he is referring to those individuals with respiratory issues that may be unable to use Afrezza. I know knit picking but it would be nice to say it improves experiences and outcomes period. It is the disclaimer that all pharma companies couch things in because of FDA. Benefits are never absolute. A study where 59 out of 60 people had better outcomes would still warrant a "potentially". Not to mention for Afrezza it can't be used for a smoker/COPD, therefore for an individual with diabetes it is only potentially that they should even use Afrezza. It's not carelessness or lack of ability, it's simply the language that must be used in this highly regulated industry.
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Post by kc on Mar 13, 2018 20:31:05 GMT -5
I think the study was completed in December, wasn’t it? I am ignorant on how studies work for presentations, but is it possible the study is under peer review so that it can be presented at the conference post peer review. Dennis you are correct that is why it’s embargoed until its presented in the ADA publication tied to the convention and published at the end. It’s the Dog & Pony show that the ADA puts on to draw people to their convention. It’s all good and we just have to let it play out.
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Post by xanet on Mar 18, 2018 15:11:46 GMT -5
There seems to be a lot of confusion about conferences and peer review. The author submits an abstract to the conference organizers. If accepted, the material is presented at the conference and the abstract or extended (more detailed) abstract is published in the conference proceedings. That is not peer reviewed, but can be cited in scientific papers. After the conference (or even before in some cases, not sure with ADA), the author is free to submit a full manuscript to any journal, where it will be reviewed first by an editor to be sure it fits the scope of the journal, and then sent for outside review. Many journals have a difficult time finding enough people to review papers, so those of us in academia get bombarded with requests to review papers within our area of expertise. If we accept, we join one or two other reviewers and provide our recommendations to the author(s) and editor. If the paper is not rejected, then generally the authors are asked to make minor or major revisions, after which the paper may be accepted for publication. I have seen the entire process take anywhere from a few weeks to more than 10 months, depending on the journal and how busy the reviewers and authors are.
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Post by matt on Mar 19, 2018 7:33:20 GMT -5
There seems to be a lot of confusion about conferences and peer review. The author submits an abstract to the conference organizers. If accepted, the material is presented at the conference and the abstract or extended (more detailed) abstract is published in the conference proceedings. That is not peer reviewed, but can be cited in scientific papers. After the conference (or even before in some cases, not sure with ADA), the author is free to submit a full manuscript to any journal, where it will be reviewed first by an editor to be sure it fits the scope of the journal, and then sent for outside review. Many journals have a difficult time finding enough people to review papers, so those of us in academia get bombarded with requests to review papers within our area of expertise. If we accept, we join one or two other reviewers and provide our recommendations to the author(s) and editor. If the paper is not rejected, then generally the authors are asked to make minor or major revisions, after which the paper may be accepted for publication. I have seen the entire process take anywhere from a few weeks to more than 10 months, depending on the journal and how busy the reviewers and authors are. That is a good summary of what really happens with peer review. To that I would add that some journals go out of their way to redact certain information (author name(s), study name, and anything that could identify the institution) to make sure that the review is not influenced by prior relationships. Obviously reviewers tend to be well-informed about events happening in their field of expertise and can still make a pretty good guess where the paper comes from, but still the process is as fair as it can be. I would also point out that just because there is a long delay getting into print does not mean the information is unavailable. Virtually all journals will make papers available on the Internet the moment they are accepted for publication. While the paper is subject to change, normally to incorporate minor comments and to allow the journal to produce publication quality graphics, the essence of the paper is there for all to see (at least those who have a subscription). The fastest journals rarely take more than six weeks between acceptance for publication and the final version while the slowest ones take up to a year. With academics, the timing can have a lot to do with what else is going on at the university (exams, graduation, vacation periods, etc.).
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Post by peppy on Mar 19, 2018 7:39:30 GMT -5
There seems to be a lot of confusion about conferences and peer review. The author submits an abstract to the conference organizers. If accepted, the material is presented at the conference and the abstract or extended (more detailed) abstract is published in the conference proceedings. That is not peer reviewed, but can be cited in scientific papers. After the conference (or even before in some cases, not sure with ADA), the author is free to submit a full manuscript to any journal, where it will be reviewed first by an editor to be sure it fits the scope of the journal, and then sent for outside review. Many journals have a difficult time finding enough people to review papers, so those of us in academia get bombarded with requests to review papers within our area of expertise. If we accept, we join one or two other reviewers and provide our recommendations to the author(s) and editor. If the paper is not rejected, then generally the authors are asked to make minor or major revisions, after which the paper may be accepted for publication. I have seen the entire process take anywhere from a few weeks to more than 10 months, depending on the journal and how busy the reviewers and authors are. That is a good summary of what really happens with peer review. To that I would add that some journals go out of their way to redact certain information (author name(s), study name, and anything that could identify the institution) to make sure that the review is not influenced by prior relationships. Obviously reviewers tend to be well-informed about events happening in their field of expertise and can still make a pretty good guess where the paper comes from, but still the process is as fair as it can be. I would also point out that just because there is a long delay getting into print does not mean the information is unavailable. Virtually all journals will make papers available on the Internet the moment they are accepted for publication. While the paper is subject to change, normally to incorporate minor comments and to allow the journal to produce publication quality graphics, the essence of the paper is there for all to see (at least those who have a subscription). The fastest journals rarely take more than six weeks between acceptance for publication and the final version while the slowest ones take up to a year. With academics, the timing can have a lot to do with what else is going on at the university (exams, graduation, vacation periods, etc.). Quote; The fastest journals rarely take more than six weeks between acceptance for publication and the final version while the slowest ones take up to a year. Reply:, by that metric, what is the fastest possible publishing date that can be calculated? please.? ADA: This year's meeting will be held June 22-26, 2018, in the West Concourse of the Orange County Convention Center in Orlando, Florida.
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Post by matt on Mar 19, 2018 8:22:42 GMT -5
Quote; The fastest journals rarely take more than six weeks between acceptance for publication and the final version while the slowest ones take up to a year. Reply:, by that metric, what is the fastest possible publishing data that can be calculated? please.? Admittedly that is a subjective opinion, but one based on a lot of experience. I normally read ten to fifteen journal articles most weeks, and some publish the dates on their Internet site. Here is the detail from one article randomly selected from my Endnote library: Received 8 February 2016; Revised 2 May 2016; Accepted 22 May 2016, Published June 15, 2016So that paper took about four months to publish and five months to make it to paper, but the "early edition" was available on-line May 22. There is no hard metric you can calculate, but if you read the same journals every month like I do then you get a feel for which ones are fast and which ones are slow. You can also tell the speed by comparing the PubMed record, which shows the actual publication date, with the date a paper was downloaded. Endnote is a software that archives all my publications (about 5,500 at last count) and it keeps track of the date I first acquired a paper and the date the PubMed record was last updated. The big commercial publishers (John Wiley for example) often go to print within a few weeks of the on-line edition, while many of the free Internet only journals can take a long time. Some Wiley articles are processed fast enough that you never see a separate on-line version' they first appear in their final form with both print and electronic versions published simultaneously. My perception, right or wrong, is that if a lot of libraries are paying several thousand dollars a year for a subscription to a journal, then the publisher has the financial resources to produce a quality publication promptly, while the free Internet only journals are staffed more by volunteers who can only devote a portion of their time to the journal. The corollary is that because those journals are charging a lot of money it is much harder to get published unless the content is of high interest, truly breaks new ground, or is the final report on an exceedingly large multi-center study. For that reason I would expect to see the STAT study appear in a specialty publication devoted to treatment of diabetes or metabolic disease in general, but not in a major journal like JAMA or Lancet.
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Post by peppy on Mar 19, 2018 8:28:40 GMT -5
ok, the gist, expect journals to be a bit pay to play as well. correct me if I am miss interpreting. please.
oh and thank you. I have started to like you more.
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Post by casualinvestor on Mar 19, 2018 8:54:03 GMT -5
So we can expect that the extended abstract to be in everyone's hands by around June 22nd. Does that mean the trial data will also be available then?
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Post by agedhippie on Mar 19, 2018 9:56:49 GMT -5
So we can expect that the extended abstract to be in everyone's hands by around June 22nd. Does that mean the trial data will also be available then? I suspect the trial data will be released a couple of days later. The presentation is in the oral presentations section rather than the main event. It's not a bad thing though because they group several speakers together based on topic so people who are interested in the area generally will be there. Each speaker gets 10 minutes to speak and 5 minutes Q&A. It's the verbal equivalent of a poster presentation (we have one of those as well). I am curious as to the oral session titles, I cannot see that at the moment.
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Post by mnkdfann on Mar 19, 2018 18:16:57 GMT -5
Quote; The fastest journals rarely take more than six weeks between acceptance for publication and the final version while the slowest ones take up to a year. Reply:, by that metric, what is the fastest possible publishing data that can be calculated? please.? Admittedly that is a subjective opinion, but one based on a lot of experience. I normally read ten to fifteen journal articles most weeks, and some publish the dates on their Internet site. Here is the detail from one article randomly selected from my Endnote library: Received 8 February 2016; Revised 2 May 2016; Accepted 22 May 2016, Published June 15, 2016So that paper took about four months to publish and five months to make it to paper, but the "early edition" was available on-line May 22. There is no hard metric you can calculate, but if you read the same journals every month like I do then you get a feel for which ones are fast and which ones are slow. You can also tell the speed by comparing the PubMed record, which shows the actual publication date, with the date a paper was downloaded. Endnote is a software that archives all my publications (about 5,500 at last count) and it keeps track of the date I first acquired a paper and the date the PubMed record was last updated. The big commercial publishers (John Wiley for example) often go to print within a few weeks of the on-line edition, while many of the free Internet only journals can take a long time. Some Wiley articles are processed fast enough that you never see a separate on-line version' they first appear in their final form with both print and electronic versions published simultaneously. My perception, right or wrong, is that if a lot of libraries are paying several thousand dollars a year for a subscription to a journal, then the publisher has the financial resources to produce a quality publication promptly, while the free Internet only journals are staffed more by volunteers who can only devote a portion of their time to the journal. Just a few points to add from my personal experience: Peer review and publication times vary hugely across disciplines and journals. E.g., some papers submitted to good journals in, say, mathematics might have their peer review take more than a year, then months for revisions to be done and reviewed, then still more months until it appears in print. Some of the traditional high quality journals (from Wiley, Springer, Elsevier, etc.) may also charge the author modest publication fees. I think that is less common than it once was. In the past, it was very common for authors to also pay for hard-copy reprints of their paper. In today's era of pdf files, this is (IMO) pretty rare. The loss of this latter income stream might explain part of why the subscription prices have gone up so much in recent years. Many libraries are canning many of the higher cost to subscribe traditional high quality journals. Too pricey. Many 'free' (typically lower quality) journals are (typically) only free to readers ... often the authors have to pay several hundreds of dollars to publish in them. Many (if not most) traditional high quality journals are also staffed by volunteers. Sure, a corporation PUBLISHES the journal, but often it is unpaid volunteers who serve as editors and referees. That's the same way many (if not most) free journals operate. Nothing I described is hard and fast. It varies by discipline, and there are many different journal models. I'm just describing what I have experience with.
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Post by mnholdem on Mar 19, 2018 22:29:50 GMT -5
Getting back to the OP:
"Improved Postprandial Blood Glucose (PPBG) Excursions with Technosphere Inhaled Insulin Compared with Aspart in T1D Patients – STAT Study” will be an oral presentation
“Improved Time-in-Range (TIR) on Continuous Glucose Monitor (CGM) with Technosphere Inhaled Insulin (TI) Compared with Aspart in T1D Patients – STAT Study” will be presented during the scientific poster session.
It hasn't escaped my attention that titles of both presentations has already informed the diabetes treatment industry of the STAT study results: Afrezza outperformed insulin aspart in these two important measurements of a diabetes treatment's effectiveness. HCPs will have to attend the presentations to learn how statistically significant that improvement was.
The STAT study began on the heels of the FDA's "Beyond a1C" meeting with industry leaders and the STAT study results are being presented a little over a year from when the industry began identifying new measurement to replace a decades-old standard. That's pretty fast.
Are any any of the giant pharmaceutical companies conducting these studies with their RAA insulin brands? Probably not, since they know the new Key Measurements will reveal how difficult it is to control blood glucose levels with injected insulin.
Perhaps the physicians group that recently advocated raising a1C goals is attempting to protect the status quo in what is a very lucrative industry?
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Post by mnholdem on Mar 20, 2018 4:44:57 GMT -5
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Post by matt on Mar 20, 2018 7:21:50 GMT -5
ok, the gist, expect journals to be a bit pay to play as well. correct me if I am miss interpreting. please. oh and thank you. I have started to like you more. I would not say that journals are pay to play. Most journals will allow articles to be viewed for free if the author pays a fee, usually about $3,000, and open access is now required for any article that results from US government sponsored research which is why you see more articles available from PubMed links. The author still has to get the article accepted and as I mentioned that is often a blinded process to keep it fair. That said, the journals that are subscription based have more financial resources to hire editors, proof-readers, have better graphics departments, and are just generally better staffed. Larger organizations can simply turn around a project faster because they have all the necessary tools in house. The garage mechanic on the corner of your street can probably fix your car given a few days, but a large dealership can likely do it faster because they will have special tools for that model and all the necessary parts in stock. Publishing is not that different.
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Post by mango on Mar 20, 2018 8:35:17 GMT -5
Getting back to the OP: " Improved Postprandial Blood Glucose (PPBG) Excursions with Technosphere Inhaled Insulin Compared with Aspart in T1D Patients – STAT Study” will be an oral presentation
“Improved Time-in-Range (TIR) on Continuous Glucose Monitor (CGM) with Technosphere Inhaled Insulin (TI) Compared with Aspart in T1D Patients – STAT Study” will be presented during the scientific poster session.
It hasn't escaped my attention that titles of both presentations has already informed the diabetes treatment industry of the STAT study results: Afrezza outperformed insulin aspart in these two important measurements of a diabetes treatment's effectiveness. HCPs will have to attend the presentations to learn how statistically significant that improvement was. The STAT study began on the heels of the FDA's "Beyond a1C" meeting with industry leaders and the STAT study results are being presented a little over a year from when the industry began identifying new measurement to replace a decades-old standard. That's pretty fast. Are any any of the giant pharmaceutical companies conducting these studies with their RAA insulin brands? Probably not, since they know the new Key Measurements will reveal how difficult it is to control blood glucose levels with injected insulin. Perhaps the physicians group that recently advocated raising a1C goals is attempting to protect the status quo in what is a very lucrative industry? Financial Conflicts of Interest: Guidance Statement for Pharmacological Treatment of Type 2 Diabetes Developed by the American College of PhysiciansForeword• 15 of the 17 individuals who served on the ACP's Clinical Guidelines Committee were, by coincidence, also the authors of the clinical guidance statement developed by the American College of Physicians entitled, Hemoglobin A1c Targets for Glycemic Control With Pharmacologic Therapy for Nonpregnant Adults With Type 2 Diabetes Mellitus. • The 2 individuals who were not authors but served on the Clinical Guidelines Committee: Scott Manaker, MD, PhD —Dr. Manaker was recused from voting on the recommendations for an active indirect financial conflict. Sandeep Vijan, MD, MS —Dr. Vijan was recused from voting on the recommendations for an active direct financial conflict. • Majority of the 17 individuals are affiliated with policy making/governing/politicking with the VA and local state and national organizations. I am concerned why they would advocate causing harm to veterans that have T2D. Financial Conflicts of Interest Disclosure1. Michael J. Barry, MD† † Author (participated in discussion and voting). • Disclosure Dr. Barry reports grants and personal fees from Healthwise, a nonprofit, outside the submitted work. • Relevant Financial Activities Outside the Submitted Work —Healthwise, a nonprofit a. Grants & Personal Fees: Salary as Chief Science Officer, up through the end of my employment at Healthwise 3/31/17. Grants to Massachusetts General Hospital for prostate research and to support the Informed Medical Decisions Program at MGH. 2. Alfonso Iorio, MD, PhD† †Author (participated in discussion and voting). • Research & Consulting NovoNordisk: Service agreement with McMaster University to chair an independent peer review grant award committee (Hemophilia Experiences Results Objectives Psycho-social Program Grant). No funds to myself. 3. Scott Manaker, MD, PhD‡ ‡ Nonauthor contributor (participated in discussion but excluded from voting). • Active Indirect Financial Conflict Dr. Manaker was recused from voting on the recommendations for an active indirect financial conflict. • Research & Consulting —UpToDate, Section Editor (Critical Care) $10,001-50,000 —Expert witness in workers' compensation and in medical negligence matters $100,001 or more • Investment & Proprietary Interests —Owns stock in 3m Health Information Systems which makes computer assisted coding/billing software, largely for hospitals $50,001-100,000 —Stock in Pfizer $50,001-100,000 —Stock in Johnson & Johnson $50,001-100,000 4. Sandeep Vijan, MD, MS‡ ‡ Nonauthor contributor (participated in discussion but excluded from voting). • Active Direct Financial Conflict Dr. Vijan was recused from voting on the recommendations for an active direct financial conflict. 5. Christine Laine, MD, MPH, Editor in Chief • Financial Conflicts of Interest Reports that her spouse has stock options/holdings with Targeted Diagnostics and Therapeutics. 6. Jaya K. Rao, MD, MHS, Deputy Editor • Financial Conflicts of Interest Reports that she has stock holdings/options in Eli Lilly and Pfizer. 7.Catharine B. Stack, PhD, MS, Deputy Editor for Statistics • Financial Conflicts of Interest Reports that she has stock holdings in Pfizer and Johnson & Johnson. American College of Physicians Department of Clinical Policy Disclosure of Interests: Summary ReportICMJE Form for Disclosure of Potential Conflicts of Interest
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