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Nice narratives

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  • "Clinical Research Regulation For India". clinregs.niaid.nih.gov. National Institute of Allergy and Infectious Diseases. 23 July 2020.
  • Srinivasan, Sandhya; Johari, Veena (26 August 2019). "Consultations on human infection studies in India: Do people's voices really count?". Indian Journal of Medical Ethics. 4 (3): 234–237. doi:10.20529/IJME.2019.011.
  • Bajpai, Vikas (2013). "Rise of Clinical Trials Industry in India: An Analysis". ISRN Public Health. 2013: 1–17. doi:10.1155/2013/167059.{{cite journal}}: CS1 maint: unflagged free DOI (link)
  • Gupta, Yk; Kumar, BDinesh (2014). "Clinical trials and evolving regulatory science in India". Indian Journal of Pharmacology. 46 (6): 575. doi:10.4103/0253-7613.144887.{{cite journal}}: CS1 maint: unflagged free DOI (link)
  • Naik, Kalindi (12 June 2017). Clinical Trials in India: History, Current Regulations, and Future Considerations (PDF) (Master of Science). Eastern Michigan University.
  • Mutham, Deepthi (May 2015). Why did the DCGI of India cease clinical trials on NCEs in India, and what changes were implemented prior to starting them again? (PDF) (Master of Science).

Blue Rasberry (talk) 16:14, 16 August 2020 (UTC)[reply]

Blue Rasberry (talk) 23:19, 7 November 2020 (UTC)[reply]

Tables and diagrams

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Blue Rasberry (talk) 12:49, 21 August 2020 (UTC)[reply]

Wanted sources

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  • Thatte, U (2006). "Good clinical practice (GCP) standards: clinical trials in India. An interview with Dr. Urmila Thatte, Head of Clinical Pharmacology, TN Medical College & BYL Nair Hospital. Interview by Viveka Roychowdhury". The journal of biolaw & business. 9 (3): 30–1. PMID 17152137.
This discussed Good clinical practice and I want to include that.

Blue Rasberry (talk) 22:15, 26 August 2020 (UTC)[reply]

Thanks Abhishek

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Thanks Abhishek for bringing my attention to this article. Feel free to ping me for any information required. I will try to share information as per my knowledge and understanding. Thanks once again. -- Dr. Abhijeet Safai (talk) 07:47, 27 August 2020 (UTC)[reply]

Did you know nomination

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The following is an archived discussion of the DYK nomination of the article below. Please do not modify this page. Subsequent comments should be made on the appropriate discussion page (such as this nomination's talk page, the article's talk page or Wikipedia talk:Did you know), unless there is consensus to re-open the discussion at this page. No further edits should be made to this page.

The result was: promoted by Cwmhiraeth (talk) 13:52, 8 November 2020 (UTC)[reply]

(
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Created by Bluerasberry (talk). Self-nominated at 14:39, 30 August 2020 (UTC).[reply]

  • New and long enough, Earwig finds no copyvios, QPQ done. There are two sentences in the "Government regulation" section with unclear citations. Both hook facts check out. This is not a DYK issue, but is there a reason you're repeating the same citations for consecutive sentences? John P. Sadowski (NIOSH) (talk) 19:14, 1 September 2020 (UTC)[reply]
@John P. Sadowski (NIOSH): Thanks for the review.
I repeated citations because I felt this article needed the extra clarity. Someone who felt otherwise could format citations in a different way.
I found those two sentences. The one about the registry I matched with a citation, and the other about state level regulation I removed and put here because I have no citation, and because that sentence needs one. I am working on another wiki article about a trial which had state regulation, but as of now, I have no source for state regulation in general.
Any other comments here? Blue Rasberry (talk) 17:27, 6 September 2020 (UTC)[reply]
state level regulation I posted this sentence without a citation. I am removing it from the article and keeping it here in the talk page. "Outside of the central government, each state has its own regional regulatory agencies with some input into governing trials." I could not find a source for this. What I did find is a few cases where state level government ordered inquiries and possibly modification to clinical trials in India, such as for the Indore trial scandal. Although some states have intervened, those cases are not a reason for generalizing, so I am just removing this until and unless anyone identifies sources. Blue Rasberry (talk) 17:27, 6 September 2020 (UTC)[reply]
Looks good to me then! John P. Sadowski (NIOSH) (talk) 03:09, 7 September 2020 (UTC)[reply]
Not sure why we've been having a rash of hooks trying to prove India is the biggest and best. Striking ALT0 in favor of ALT1. Yoninah (talk) 20:38, 8 September 2020 (UTC)[reply]
@Yoninah: Thanks for selecting a hook. It is fine. Blue Rasberry (talk) 21:18, 8 September 2020 (UTC)[reply]
Hi, I came by to promote this, but I do not see anything about the Supreme Court making trials safer; there is only something about making them more ethical, with a cite. Could you point out the cited hook fact to me please? Yoninah (talk) 23:45, 10 September 2020 (UTC)[reply]
@Yoninah: I re-read the source and you are right, it does not say that they wanted to make trials safer as I wrote. It only says that if the research kills people then there should be compensation, and it makes the claim that paying in case of death would make the trials more ethical. I think other sources talk about safety, and I think safety is the intent, but you are right, I should not be interpreting this source in that way. I wrote another hook which replaces "safer for research participants" with "more ethical", which better matches the source. Thanks for preventing a later potential problem for me. Blue Rasberry (talk) 01:00, 11 September 2020 (UTC)[reply]
@Blue Rasberry: thank you, but while you're writing the hook in an active voice, saying that the Supreme Court ordered this reform, the Supreme Court is not the actor in the article; rather it seems like "government agencies" enacted reforms on their own in this sentence: Following the 2013 case Swasthya Adhikar Manch v. Union of India in the Supreme Court of India, various government agencies reformed their regulations to make clinical trials more ethical. Yoninah (talk) 11:10, 11 September 2020 (UTC)[reply]

@Yoninah: Thanks for the feedback. It might be simplest and still accurate to do exactly what you suggest, and say

It is as you say, various government agencies made the changes. I interpreted the sources to say that the 2013 Swasthya Adhikar Manch v. Union of India case led to the Supreme Court ordering changes, but as you say, it is not the courts which order changes. As I looked at available sources, I found them to be dodgy about who committed to make the reforms. I am just guessing, but I think the court case identified some chaos and multiple government agencies took some years to sort out their responsibilities. Also, there were 2019 reforms as well, and although I personally cannot see the differences between pre2013, 2013-19, and 2019 onward, I think it may be best to avoid presenting sources about the transition period and just talk about how things are now. I have a new hook and a new source:

Blue Rasberry (talk) 19:42, 29 September 2020 (UTC)[reply]

I disagree with the claim that the first proposed hook presents India as "the biggest and best". IMO it presents India as one of the worst. About 17% of people live in India. 1.2% of clinical trials are happening there. That means that India is doing 1/15th of its 'fair share' of medical research. WhatamIdoing (talk) 17:27, 25 September 2020 (UTC)[reply]
@Bluerasberry: thanks for ALT4, but you have "India" twice in the hook. I'm looking at the article section 2013 to 2019 and it seems like the paragraphs are jumbled up. There's a half-sentence in there and the rest doesn't flow smoothly. Yoninah (talk) 22:10, 29 September 2020 (UTC)[reply]
@Bluerasberry and Yoninah: I'm offering an Alt. Evrik (talk) 19:29, 10 October 2020 (UTC)[reply]
@Yoninah: Yes the content in that section was jumbled. I just edited it to fix the omission and try to make it easier to read. See changes at special:diff/981036200/983037404.
@Evrik: Yes I support ALT4a, this is the core message. Blue Rasberry (talk) 21:50, 11 October 2020 (UTC)[reply]


General: Article is new enough and long enough
Policy: Article is sourced, neutral, and free of copyright problems
Hook: Hook has been verified by provided inline citation
QPQ: Done.

Overall: ALT4a has been approved by reviewers and the creator (I have struck out the rest). All issues are fine and/or have been resolved - except for neutrality in my opinion. In the Comparison section, it states that "India is an attractive place for both Indian and foreign clinical research for various reasons", then the rest of the paragraph states those good reasons. However the Gupta 2014 source says that "Few years ago, India was considered a preferred destination for conducting clinical trials", then it mentions incidents, problems with the Media, debate, attempts to resolve matters and a need to resolve things further. It may be that the source is only a summary of the article, and maybe the original article does back up the "attractive place" phrase, but the online summary does not give that impression. So I suggest that you either re-write that paragraph to fit the Gupta 2014 source, or find a source which supports that paragraph. If this matter of neutrality can be resolved, then I believe this article can be passed for DYK. Storye book (talk) 11:59, 16 October 2020 (UTC)[reply]

@Storye book: That makes sense, let me review the text and sources. I will do that by end of day tomorrow. Blue Rasberry (talk) 14:11, 16 October 2020 (UTC)[reply]
Thank you, Bluerasberry. To tell the truth, I have been rather worried that there may be more sources which do not match your text. Please would you kindly check right through the whole article to make sure that there are no more situations where the source does not support the text? The DYK elves do thorough checks, and we don't want your nomination to be thrown out of prep. It's better to check now than later. Thank you. Storye book (talk) 14:44, 16 October 2020 (UTC)[reply]
@Storye book: I will look again and reconsider my words. Right now I have not thought it through. Let me read and think some more. Thanks for your candor, I would rather hear this now rather than later. Blue Rasberry (talk) 15:10, 16 October 2020 (UTC)[reply]
Thank you, Bluerasberry. This article is about a serious and important subject, and I know you will do your best to get it right. Storye book (talk) 15:28, 16 October 2020 (UTC)[reply]
I need an additional day. I will finish responding by end of day Sunday 18 October. Blue Rasberry (talk) 15:57, 17 October 2020 (UTC)[reply]
  • Thank you. 16:13, 17 October 2020 (UTC)

@Storye book: I made some edits which I think are an improvement to various parts of the article. I am still ready to make further changes on request and with more time. The particular issue above was me naming advantages and saying that they made India "attractive". I balanced this by citing a source which has section headings for various favorable characteristics and unfavorable characteristics of research in India.

  • Perkovic, Vlado; Patil, Vinodvenkatesh; Wei, Liu; Lv, Jicheng; Petersen, Marisa; Patel, Anushka (July 2012). "Global Randomized Trials: The Promise of India and China". The Journal of Bone and Joint Surgery-American Volume. 94 (Suppl 1): 92–96. doi:10.2106/JBJS.L.00274. PMID 22810456.

I added some of those challenges and also changed the "attractive" statements to "attractive and challenging", so that characteristics of all kinds appear together. As for the word "attractive", I considered changing it to favorable, advantageous, but have not done so. If the word still seems distracting even with the challenges counterbalancing it, then I will think more about it or seek suggestions from others. For now, this is what I have. Thoughts? Blue Rasberry (talk) 00:21, 19 October 2020 (UTC)[reply]

  • for ALT4a. Thank you, Blue Rasberry for your updates on the article. As far as I can see, you have resolved all the above issues. The article covers a big subject, so no doubt more updates will be needed in future, but for now I believe that the article should be OK for DYK. Thank you for all your had work. Storye book (talk) 11:52, 19 October 2020 (UTC)[reply]
  • Hi, I came by to promote ALT4a, but while the source may be saying the law was designed to protect participants in clinical trials, the article only says that the law provided more guidance for how the ethics committee of a clinical trial should oversee it. Yoninah (talk) 19:26, 19 October 2020 (UTC)[reply]
  • Citation 1, page x in the article is about guidelines, not the law - I agree. But that page does refer to "providing adequate protection to the vulnerable population," and the guidelines are there to strengthen the law which is what the hook ALT4a is about. Citation 2, which is appended to a sentence about the 2019 law at the beginning of the header, is untranslatable for my pc, but if it's about publicly documenting clinical trials then I should have thought that that involved protecting trial-participants? @Blue Rasberry: @Evrik: Have you got a better citation for ALT4a? Storye book (talk) 20:03, 19 October 2020 (UTC)[reply]
  • @BlueRasberry. This DYK nomination is being held up by a problem with the source of ALT4a. If you want to get this to DYK anytime soon, then please could you kindly give us another ALT with a clear source (which you can translate for us if necessary)? Or could anyone else suggest an alternative ALT with citation? Thank you. Storye book (talk) 11:08, 2 November 2020 (UTC)[reply]
Acknowledged will update within 1 day. Blue Rasberry (talk) 12:39, 2 November 2020 (UTC)[reply]
notes (optional)

I took for granted that coming up with a hook would be easy. After all the above discussion which correctly identified that my suggestions for hooks were too loose, I looked again, and I still find it difficult. There has definitely been Indian government regulation about clinical trials starting around 2005. However, sources make varying claims beyond that. Some sources say that the changes protect participants; other say that the changes favor corporations at the expense of participant safety. Some sources say that the Indian government instituted the changes, but other sources emphasize that the changes originate in private sector organizations like ethics committees which may be part of universities or various kinds of self regulation in corporations. I identified no source anywhere cited that is particularly strong or comprehensive. Most sources either are a news item or a specialist publication only covering a narrow aspect of the changes. None of the proposals I made previously quite work because they were too specific and presume more than the source stated.

@Storye book:
Here is another go at some hooks

These hooks do not say who the changes benefit or who exactly designed them. Instead, these hooks present the consensus that definitely some big changes happened, and the changes came into effect because of regulation by government's amendment of an act of parliament. Blue Rasberry (talk) 02:55, 3 November 2020 (UTC)[reply]

  • Thank you, Blue Rasberry. I appreciate that amount of time and work that you are contributing here. I am happy with ALTs 5, 5a and 5b. @Yoninah:? (Note: if you want ALT6b, to improve the English I suggest changing "2005–2016" to "2005 and 2016.")Storye book (talk) 10:26, 3 November 2020 (UTC)[reply]
@Storye book and Yoninah: ALT4a makes two claims: one is that the Indian government should have credit for the reforms, and the other is that the reforms benefit individual research participants as opposed to corporations or some other stakeholder. Previously by my own bias I fabricated a presumption that the government did this regulation to benefit citizens, after more careful reading I found various contrarian claims that it was neither the government nor a benefit to citizens. I favor scrapping ALT4a as inaccurate or at least without evidence to cite.
I can show the contrarian sources, but there are some claims that credit for the reforms should go to academics, or corporations, or investors, or citizen's rights groups, or government regulators. By the sources, I interpret that all of these stakeholders are in contention with the others. Likewise, any identification of the beneficiary of the reforms is likewise contentious, as all stakeholders are at odds with the others and each one blames the others for getting the benefits at the expense of their own group. Whatever happened in the reforms is neither with diverse consensus nor fully developed conversation. The most problematic part about all of this is that despite all the sources talking about the reforms, none of those sources seems to come from a writer with a comprehensive understanding of what the reforms are and what they do.
I can re-write some other prompts going in a different direction. To me, the fact of the reforms is big news, because this entire topic is about a matter concerning 1-2 billion people over at least a generation and directing the consumption of probably US$1 trillion+ which would not have been invested this way were it not for the regulations. That is just my estimation. I am embarrassed to be without much evidence as to how something which seems so high impact can be so scant in the sources.
I would go in a different direction with alternate proposals but I would appreciate a prompt or suggestion. I can definitely be more specific and hooky with a detail of less consequence than the fact of the regulations. Suggest something to me, please. Blue Rasberry (talk) 17:46, 3 November 2020 (UTC)[reply]
I got distracted, I will do this by end of today. Pardon the lateness please. Blue Rasberry (talk) 13:06, 5 November 2020 (UTC)[reply]

@Storye book and Yoninah:

I think this is a good fact from a good source. The The National Medical Journal of India comes from the All India Institute of Medical Sciences, which itself has a special relationship with the Indian government and has recognition as being among the best medical schools in India. This 2019 paper gives a weighty statement of the state of ethics committees. Blue Rasberry (talk) 00:35, 6 November 2020 (UTC)[reply]

  • for ALTs 6 and 6a. Note: Although I like ALT6b best because it makes all clinical trials sound safe, the source quote that you have given does not back it up. The quote does not state that every clinical trial is monitored by an ethics committee. Is there another sentence in the source which backs up the word "every"? Yoninah?Storye book (talk) 11:32, 6 November 2020 (UTC)[reply]
Acknowledged, good point to clarify, can revise, will post by tomorrow (Saturday 7 Nov New York time) afternoon. Blue Rasberry (talk) 14:42, 6 November 2020 (UTC)[reply]
@Storye book: TLDR; ALT6b not explicitly confirmed Okay, so this was more complicated than I thought also. ALT6 and ALT6a just say that a government registered ethics committee oversees clinical trials. In ALT6b I made the claim that each and every trial has an associated ethics committee. To me it seemed obvious that all trials have a designated third-party ethics committee, but based only on what the texts say, a possible (and I claim, incorrect) interpretation is that ethics committees only review some trials, perhaps by random sample. For ALT6b I want to make the claim that every trial must have an assigned ethics committee which always goes through the review.
In the text till now I had cited three sources about ethics committees, which were Das 2019; Gupta 2014; and Chatterjee 2013. All of these say that ethics committees review trials, and they sometimes state that ethics committees can review every trial, but they do not say that every trial gets an ethics committee to review it.
I found another source, and while it does not explicitly state "every trial has an ethics committee", it does say that ethics committees have certain responsibilities for every trial.
The best statement that I found here is, "Apart from the review of continuing reports, protocol deviations,[60] and SAEs,[56] ECs must make efforts to conduct on-site monitoring." This is what I expect of an ethics committee anywhere: review of the protocol before the study, be point of conduct for injuries (SAEs), and check for protocol deviations including by quality assurance in person at the clinical site. However, I cannot find a statement here or in the other sources which explicitly states this happens for every trial. I expect that the central government regulatory documents state this clearly, but I do not see it in any of these sources. We can do
This is what I have for now. I crossed out ALT6b as without explicit sourcing. ALT6c should work. Thoughts? Thanks for the questions. They are good. I myself am wondering if somehow, there are categories of clinical trials which do not require monitoring. Blue Rasberry (talk) 00:27, 8 November 2020 (UTC)[reply]
  • @Bluerasberry. Thank you for sorting this out. I agree that 6b ought to be true, and we have no evidence to the contrary, but there is such a thing as international rivalry regarding the provision of clinical trials right now, and that sort of thing invites questions about safety, unfortunately. As far as I can see, the remaining three ALTs don't provide a space for pessimistic questions, and that has to be a good thing. Storye book (talk) 10:47, 8 November 2020 (UTC)[reply]
  • for ALTs 6, 6a and 6c (I have no preference between these three). Thank you, Bluerasberry. Storye book (talk) 10:47, 8 November 2020 (UTC)[reply]
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