tag:blogger.com,1999:blog-6782790349293784670.comments2023-10-04T06:06:07.716-05:00<a href="http://www.placebocontrol.com">Placebo Control</a>Unknownnoreply@blogger.comBlogger47125tag:blogger.com,1999:blog-6782790349293784670.post-9392603593266279742023-10-04T06:06:07.716-05:002023-10-04T06:06:07.716-05:00I have been examinating out many of your stories a...I have been examinating out many of your stories and it’s pretty good stuff. <a href="https://beautywebblog.com/engaging-in-experiential-therapy-for-personal-growth/" rel="nofollow">Experiential therapy for teens</a><br />365 pro Serviceshttps://www.blogger.com/profile/05929652122561561146noreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-91302219775800295222023-06-21T23:38:36.221-05:002023-06-21T23:38:36.221-05:00This is awesomeeThis is awesomeeAnie Francishttps://aniefrancis.blogspot.com/noreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-54488863707055059112023-06-19T23:05:01.794-05:002023-06-19T23:05:01.794-05:00Lovely blog, thanks for taking the time to share t...Lovely blog, thanks for taking the time to share this. Vaw Awareness Monthhttps://vawawarenessmonth.wordpress.com/noreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-39973464433019307432023-05-11T06:20:25.181-05:002023-05-11T06:20:25.181-05:00Thhis is a great postThhis is a great postWill Lennardhttps://medium.com/@Will_Lennardnoreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-51328111882062010422022-12-07T07:14:35.105-06:002022-12-07T07:14:35.105-06:00Like different bonuses, your welcome bonus must be...Like different bonuses, your welcome bonus must be wagered a certain number of times before you'll be able to|you presumably can} withdraw it. Not all games contribute equally to the rollover necessities. For instance, slots usually depend one hundred pc path of|in path of} assembly your wagering necessities, whereas table games like blackjack and roulette only contribute 10-20%. 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No-deposit bonuses are much less widespread, however they're nice if you want to|if you want to} check out a casino without risking any of your own cash.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-82250536637185521612019-08-06T21:38:51.120-05:002019-08-06T21:38:51.120-05:00Maybe AI can help out http://clinicalresearchtech....Maybe AI can help out http://clinicalresearchtech.com/2019/08/06/the-role-of-artificial-intelligence-in-clinical-trial-enrollments/James Pattersonnoreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-15845135540778417422017-08-25T04:49:49.800-05:002017-08-25T04:49:49.800-05:00Patients consent to trials as they are desperate f...Patients consent to trials as they are desperate for an opportunity to find a cure for their illness. However when results are not observed for a long period of time they back out.Jackhttps://www.blogger.com/profile/10147590439884797469noreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-31584382230004666582017-05-25T07:51:41.030-05:002017-05-25T07:51:41.030-05:00Ellen, I couldn't agree more. I think we shoul...Ellen, I couldn't agree more. I think we shouldn't start from a fixed idea (like, "getting rid of sites will improve everything"), but rather look hard at our trials to identify the specific points where they aren't working for participants. Then we can re-design trials to address those specific issues. I think this is more work initially, but the end product will be a much more patient-friendly trial. This also gives us the ability to continue tweaking various elements, optimizing the patient experience over many trials.Paul Ivsinhttps://www.blogger.com/profile/06181799073130665855noreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-55899463859628690052017-05-24T16:06:00.861-05:002017-05-24T16:06:00.861-05:00Patients have opinions and preferences as varied a...Patients have opinions and preferences as varied as the number of people who may be enrolled in a study. Assumptions made in study design might be too narrow to 'fit' a wide enough sample of prospective patients to move the enrollment counter.<br /><br />As alternate-site visit providers, we meet patients where it is most convenient - for the patient. That may mean seeing them at home, school, the office or even at their long-planned vacation destination.<br /><br />Could it be that a combination of traditional and virtual designs is a better vision to work toward? Some activities are most effectively handled at sites, with routine visits taken to the patient. This combination may allow for fewer sites, each able to enroll and serve a larger number of patients.Ellen Weisshttp://www.symphonyclinicalresearch.comnoreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-29571467636536623842017-02-07T14:08:28.685-06:002017-02-07T14:08:28.685-06:00Thanks, Paul. I never met -- or talked to -- Jerr...Thanks, Paul. I never met -- or talked to -- Jerry. Just Twitter. But the effect he had both on patients and colleagues is evident, and it warms me to read about the lasting impressions he's left on his community. Through all of you, he lives on.Laure Meehanhttps://www.blogger.com/profile/11510987152521069625noreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-69098779456082463502014-03-14T14:54:29.671-05:002014-03-14T14:54:29.671-05:00Hi Carrie,
I have a demo template excel file for ...Hi Carrie,<br /><br />I have a demo template excel file for that graph that'd I'd be happy to email - just drop me a line at paul.ivsin at Gmail and I'll send it over.<br /><br />Thanks,<br />PaulPaul Ivsinhttps://www.blogger.com/profile/06181799073130665855noreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-64310967358936291012014-03-14T14:23:56.822-05:002014-03-14T14:23:56.822-05:00How do you create a graph like the last one in exc...How do you create a graph like the last one in excel. This is exactly how we want to show our enrollment dataCarrienoreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-36973055436156089442014-01-14T20:51:29.418-06:002014-01-14T20:51:29.418-06:00My comment re: blockbusters was predicated on the ...My comment re: blockbusters was predicated on the following publication<br /><br />http://www.argentumlux.org/~andrewlo/documents/Can_Financial_Engineering_Cure_Cancer.pdf<br /><br />In Section I, the authors hypothesize a drug costing $200 mil to develop with a 5% chance of approval in 10 years, generating $2 billion in income over the next ten years. So, from a pool of 150 candidates (i.e. $3 bil fund), about 8 would have to be approvedCBThttps://www.blogger.com/profile/17591365910118490685noreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-4924137075482767982014-01-14T17:15:32.546-06:002014-01-14T17:15:32.546-06:00Thanks for the comment! It's interesting that ...Thanks for the comment! It's interesting that the model requires blockbusters - do you have any sense of what percentage of the portfolio would need to hit it big?<br /><br />I did notice that the megafund apparently assumes short-term revenue by selling off some of its early successes. That would be a good topic of discussion - I wonder if the authors have any idea how hard it is to get any value from early stage compounds?Paul Ivsinhttps://www.blogger.com/profile/06181799073130665855noreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-92218699428940635152014-01-13T09:46:09.285-06:002014-01-13T09:46:09.285-06:00I applaud the attempt by Roger et al in terms of e...I applaud the attempt by Roger et al in terms of exploring innovative approaches to address clinical trial backlogs. The model relies heavily on the approval of blockbusters, and although I am sure it is possible to identify 150-200 such candidates, I highly doubt you could find that many in cancer. Of the top 10 cancer selling drugs in the United States, only Rituxan and Avastin have revenues in excess of $2 billion per year. Further to your comparison with Pfizer, its oncology division only accounts for 3% of revenue. This is to be expected given our increasingly personalized understanding of cancer treatment<br /><br />References:<br />http://www.fiercepharma.com/special-reports/top-10-best-selling-cancer-drugs/top-10-best-selling-cancer-drugs<br />http://www.fool.com/investing/general/2013/11/01/a-closer-look-at-pfizers-oncology-business.aspxCBThttps://www.blogger.com/profile/17591365910118490685noreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-33559522736068685322013-09-23T04:51:37.553-05:002013-09-23T04:51:37.553-05:00Interesting post, Paul.
As I see it, there are tw...Interesting post, Paul.<br /><br />As I see it, there are two quite separate issues here.<br /><br />1. Has the number of patients participating in clinical trials tripled in the last 6 years?<br /><br />2. Does involving patients in the design of research make studies 4 times more likely to hit their recruitment targets?<br /><br />Let's start with No 1. I share your skepticism that a tripling of participation is real. I've had a look at the links you cite, and as far as I can tell what the figures are showing is a tripling of patients recruited into studies within the NIHR Clinical Research Network Portfolio. I haven't looked in enough detail to assess whether the claim that that figure really has tripled is robust, but if we accept for the sake of argument that it is, then that is absolutely not the same thing as saying that the number of patients recruited into clinical research in the UK has tripled. Some studies in the UK are part of the NIHR CRN, and some aren't. Looking at the figures for NIHR CRN studies alone tells us nothing about the total: if the number of NIHR CRN studies is increasing, it could be because more studies are being done overall, or it could be because a greater proportion of the total studies are being done within the NIHR CRN.<br /><br />There is nothing in the information provided that I can see that allows us to distinguish between those possibilities. So the claim that the number of patients overall has trebled appears to lack evidence.<br /><br />Turning to the second issue, that's a bit of a no-brainer. Of course an odds ratio of 4 is not the same thing as "4 times more likely", as you have already explained very clearly.<br /><br />It's also worth noting, of course, that the odds ratio of 4 is not derived from randomised data, so we can't conclude that higher levels of patient involvement cause better recruitment. All we can conclude is that they are associated with better recruitment, but we can't rule out that this may be because of some confounding factor. Note also that the confidence interval around that odds ratio of 4 is quite wide. They don't report it in the paper, but based on the standard error for the beta coefficient that they report, I make the confidence interval 1.1 to 15. A pretty wide range.<br /><br />That said, it seems entirely plausible that better patient involvement really does cause better recruitment, so I don't want to be too skeptical about that result.<br /><br />It's also worth noting that greater involvement of patients in the design of research is something of a hot topic for NIHR at the moment. Here the causal relationships get really complicated! Is it a hot topic because of mounting research evidence showing its benefits, or is the research showing its benefits being talked up inappropriately because it's a hot topic?<br /><br />I honestly don't know the answer to that question, but I suspect it's a bit of both.Adam Jacobshttp://dianthus.co.uknoreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-5698722663479686752013-09-19T10:56:53.906-05:002013-09-19T10:56:53.906-05:00I thank the authors for taking the time to provide...I thank the authors for taking the time to provide a lengthy response. I will consider the points raised, and hope to have a follow-up post very soon.<br /><br />However, I will highlight one key sentence now. You write: <br /><br /><i>"Your comment on the media coverage of odds ratios is an issue that scientists need to overcome (there is even a section in Wikipedia)."</i><br /><br />It's highly unfair to blame "media coverage" for the use of an odds ratio as if it were a relative risk ratio. <b>In fact, the first instance of "4 times more likely" appears in <a href="http://www.slam.nhs.uk/our-blog/brcu/developing-best-treatments-means-patient-involvement-every-step-of-the-way" rel="nofollow">Dr Wykes's own blog post</a></b>. It's repeated in the KCL press release, so you yourselves appear to have been the source of the error. <br /><br />If I have misunderstood this somehow, please let me know.<br /><br />Thanks,<br />PaulPaul Ivsinhttps://www.blogger.com/profile/06181799073130665855noreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-78768636858635102252013-09-19T08:08:27.217-05:002013-09-19T08:08:27.217-05:00There were a number of points you made in your blo...There were a number of points you made in your blog and the title of questionable maths was what caught our eye and so we reply on facts and provide context.<br /><br />Firstly, this is a UK study where the vast majority of UK clinical trials take place in the NHS. It is about patient involvement in mental health studies - an area where recruitment is difficult because of stigma and discrimination.<br /><br />1. Tripling of studies - You dispute NIHR figures recorded on a national database and support your claim with a lone anecdote - hardly data that provides confidence. The reason we can improve recruitment is that NIHR has a Clinical Research Network which provides extra staff, within the NHS, to support high quality clinical studies and has improved recruitment success. <br />2. Large database: We have the largest database of detailed study information and patient involvement data - I have trawled the world for a bigger one and NIMH say there certainly isn't one in the USA. This means few places where patient impact can actually be measured<br />3. Number of studies: The database has 374 studies which showed among other results that service user involvement increased over time probably following changes by funders e.g. NIHR requests information in the grant proposal on how service users have been and will be involved - one of the few national funders to take this issue seriously. <br /> 4. Analysis of patient involvement involves the 124 studies that have completed. You cannot analyse recruitment success unless then. The complexity measure was developed following a Delphi exercise with clinicians, clinical academics and study delivery staff to include variables likely to be barriers to recruitment. It predicts delivery difficulty (meeting recruitment & delivery staff time). But of course you know all that as it was in the paper. <br />6. All studies funded by NIHR partners were included – we only excluded studies funded without peer review, not won competitively. For the involvement analysis we excluded industry studies because of not being able to contact end users and where inclusion compromised our analysis reliability due to small group sizes.<br /><br />I am sure you are aware of the high standing of the journal and its robust peer review. We understand that our results must withstand the scrutiny of other scientists but many of your comments were unwarranted. This is the first in the world to investigate patient involvement impact. No other databases apart from the one held by the NIHR Mental Health Research Network is available to test – we only wish they were.<br /><br />Your comment on the media coverage of odds ratios is an issue that scientists need to overcome (there is even a section in Wikipedia). You point out the base rate issue but of course in a logistic regression you also take into account all the other variables that may impinge on the outcome prior to assessing the effects of our key variable patient involvement - as we did – and showed that the odds ratio is 4.12 - So no dispute about that. We have followed up our analysis to produce a statement that the public will understand. Using the following equations:<br />Model predicted recruitment lowest level of involvement exp(2.489-.193*8.8-1.477)/(1+exp(2.489-.193*8.8-1.477))=0.33<br />Model predicted recruitment highest level of involvement exp(2.489-.193*8.8-1.477+1.415)/(1+exp(2.489-.193*8.8-1.477+1.415)=0.67<br />For a study of typical complexity without a follow up increasing involvement from the lowest to the highest levels increased recruitment from 33% to 66% i.e. a doubling. This is important and is the first time that impact has been shown for patient involvement on the study success. Luckily in the UK we have a network that now supports clinicians to be involved and a system for ensuring study feasibility. The addition of patient involvement is the additional bonus that allows recruitment to increase over time and so cutting down the time for treatments to get to patients.Til Wykes and Liam Ennisnoreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-34482721038619185322013-09-18T00:53:43.216-05:002013-09-18T00:53:43.216-05:00Simon,
Thanks for your comments. I'm all for ...Simon,<br /><br />Thanks for your comments. I'm all for getting hard numbers, but I think the hard numbers need to go hand-in-hand with hard analysis. This study is limited, but it's still a nice first step - what I object to is the public representation of the study results.<br /><br />You say you've "brazenly pushed" this evidence. Does that mean that you believe that involving a patient on the study team will make a study 4 times more likely to enroll successfully? What's your take on the issues raised?<br /><br />I have no doubt that many sites are very resistant to patient involvement in their study designs. However, I worry that their resistance will only harden if they feel that data is being juked to support an opposing position.<br /><br />Thanks,<br />PaulPaul Ivsinhttps://www.blogger.com/profile/06181799073130665855noreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-86514697725276749752013-09-17T14:15:05.333-05:002013-09-17T14:15:05.333-05:00It is really interesting and helpful to have this ...It is really interesting and helpful to have this perspective Paul. I am one of those who has brazenly pushed this evidence as for all its faults it does also put some harder numbers on the impact of PPI. <br />Have you written to Til to get her perspective on the points you have made? How would you suggest we build a more robust evidence base?<br />Your support would be most welcome by this and others of my colleagues who find research institutions and their staff quite resistant to public involvement.<br />Simon Denegrihttp://simondenegri.com/noreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-58313861839296245872013-09-04T13:40:24.815-05:002013-09-04T13:40:24.815-05:00Thanks, Scott - I agree there are a lot of complex...Thanks, Scott - I agree there are a lot of complex details in pediatric medicine. I'm generally quite a fan of BPCA and PREA, given how little evidence we had before they became law. However, I'd really like to see our collected experiences of the past decade come together into more general principles of pediatric medicine. I think those kinds of principles would have some relevance in the emergency setting as well.<br /><br />PaulPaul Ivsinhttps://www.blogger.com/profile/06181799073130665855noreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-27236049404545209952013-09-04T08:37:14.145-05:002013-09-04T08:37:14.145-05:00I've not often thought about how adult clinica...I've not often thought about how adult clinical trials translate to pediatric patients. This is a good blog post that made me think of how emergency management officials in hospitals face similar situations -- how to prepare for pediatric patients in a disaster in terms of doses, medical device sizes, approaches to treatment, etc. These are some interesting nuances that you bring up.Scott Wallask, Senior Program Managerhttp://www.cbinet.comnoreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-66402377938549880922013-08-15T17:38:33.924-05:002013-08-15T17:38:33.924-05:00Thanks for the comment. I think there are a couple...Thanks for the comment. I think there are a couple things to consider here:<br /><br />1. I don't think that any of the companies that are part of Transcelerate currently source their comparator drugs at the site level. There are experienced companies that handle clinical trial drug supply, and big pharma – as far as I can tell – uses those companies. That's why Gill's reference to problems in the retail drug supply is, to me, entirely disingenuous.<br /><br />2. The fact that something <i>might</i> happen does not make it a real candidate for risk management. If Transcelerate had announced that their members would no longer utilize clinical trial sites in California “to totally mitigate the risk of clinical trial participants dying in earthquakes,” wouldn’t that merit a raised eyebrow? <br /><br />So, to me, it appears that Transcelerate is either trying to take credit for solving a problem that doesn't really exist, or is casting aspersions on comparator sourcing companies, or both.Paul Ivsinhttps://www.blogger.com/profile/06181799073130665855noreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-15403793512591712102013-08-15T17:19:09.187-05:002013-08-15T17:19:09.187-05:00Hi Ed,
Thanks for the update. I'm going to tr...Hi Ed,<br /><br />Thanks for the update. I'm going to try one more time with the authors, and if that fails will produce and post an extract from ClinicalTrials.gov in order to (try to) replicate their methods.<br /><br />The conversations I've had in the past weeks with pharma clients have further solidified my opinion that there is a high rate of compliance with FDAAA reporting requirements. There seems to be no way to reconcile the issues apart from public review of the actual data.<br /><br />PaulPaul Ivsinhttps://www.blogger.com/profile/06181799073130665855noreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-39111605492920994332013-08-15T16:14:28.081-05:002013-08-15T16:14:28.081-05:00So you think that if a company chooses to run a cl...So you think that if a company chooses to run a clinical trial as "site sourced" trial rather than a "central supply" in a country that may not have a great supply chain that this couldn't happen? Just a few months ago there was counterfeit Avastin was being sold to doctors in the US. What this isn't happening in less regulated countries? While I will say that maybe this company is capitalizing on a slice of fear, I don't see how this really should be a total surprise...Anonymousnoreply@blogger.com