[Draft] Rigorous Trialling of Medication

[Maowi]

"This draft is an intended replacement for GA#82. It ensures that research conducted on new medical drugs is carried out with no tricks or concealment by pharmaceutical companies from medical professionals and patients, to avoid endangering consumers in the drive for profit. Again, I am grateful for all feedback."

~ Feargal Yurilevich

Latest draft co-authored with Apatosaurus!

Rigorous Trialling of Medication

Category: Health | Area of Effect: Research

The World Assembly,

Asserting that without clinical trials, newly developed drugs may have profoundly damaging and unforeseen effects on patients,

Aware that in many cases, pharmaceutical companies benefit financially from positive clinical trial results for the drugs they produce, as these may lead to more sales,

Regretting that as a result these companies seek to conduct clinical trials in such a way as to ensure outcomes which portray their drugs well, instead of seeking to maximise scientific discipline and rigour,

Appalled furthermore that the manipulation by companies of public perception of their drugs, by choosing selectively which data are made publicly available, may be unregulated at the national level, and

Dismayed that this has a huge detrimental effect on the effective treatment of countless patients, and that medical professionals are often individually powerless to combat the issue,

Hereby enacts the following:

1. For the purposes of this resolution:
   
   
   1. A "double blind procedure" is defined as a procedure in which the individuals participating in a study as test subjects, administering substances for the study, or collecting data directly from the test subjects do not know during the study what substance each test subject is receiving.
      
      
   2. A “clinical trial” means the testing of a drug, in which the drug being tested, as well as any other placebos or drugs being used for comparison purposes, is administered to sapient individuals.
      
      
   3. “Informed consent” means verifiable consent provided by an individual, in which the individual consenting is fully aware of what they are consenting to, and all known, possible, significant consequences, both positive and negative, thereof.
2. No newly developed pharmaceutical drug will become available for public use by sapients, either with or without prescription from a medical professional, unless it has undergone a clinical drug trial which meets the following conditions:
   
   
   1. The safest and most effective dosage and method of administration of the drug being tested must have already been determined before the clinical trial; this dosage and method of administration must be used in the clinical trial.
      
      
   2. Different sets of participants shall receive either the drug being tested or a placebo. If said drug is being developed as a more effective alternative of an already available, developed and existing drug, then that existing drug shall be used instead of the placebo.
      
      
   3. Said trial must follow a double blind procedure.
      
      
   4. In the trial, the sample of patients trialling the drug in question must be equal in size to the sample of patients trialling the second drug or placebo in each of the above cases, and must be selected using the same method and requirements.
3. Subject to extant World Assembly resolutions, no individual is to participate in a clinical drug trial as a test subject unless:
   
   
   1. the subject has provided informed consent to participation in the trial, and has done so free from coercion or threats, or
      
      
   2. if the subject is legally unable to provide informed consent to the participation in the trial, their legal guardian has done so free from coercion or threats, and the potential benefit arising from the subject's participation unambiguously outweighs the risk of harm to the subject.
4. Money or other material incentives may be given as incentives for participation in a clinical trial, provided that the quantity of said incentives is determined entirely independently to the risk of participation.
   
   
5. If the drug under investigation in a clinical drug trial is being compared to another drug, the drug being used for comparison must be administered in clinically standard dosages and with clinically standard regularity.
   
   
6. Any information that will or will likely have a cognisable impact on the safety or effectiveness of a drug being tested in a clinical trial must be collected in said clinical trial, should such collection be practical.
   
   
7. Should the drug in question become available for public use, either with or without prescription from a medical professional, all Section 6 data, along with the methodology and both raw and processed results, must be available for viewing by consumers and medical professionals, readily and free of charge.
   
   
8. Singular words and phrases shall include the plural thereof unless indicated otherwise. Member states must interpret and obey this resolution in good faith.

OOC:
Repeal draft here

Drafts

Rigorous Trialling of Medication

Category: Health | Area of Effect: Research

The World Assembly,

Asserting that without clinical trials, newly developed drugs may have profoundly damaging and unforeseen effects on patients,

Aware that in many cases, pharmaceutical companies benefit financially from positive clinical trial results for the drugs they produce, as these may lead to more sales,

Regretting that as a result these companies seek to conduct clinical trials in such a way as to ensure outcomes which portray their drugs well, instead of seeking to maximise scientific discipline and rigour,

Appalled furthermore that the manipulation by companies of public perception of their drugs, by choosing selectively which data are made publicly available, may be unregulated at the national level, and

Dismayed that this has a huge detrimental effect on the effective treatment of countless patients, and that medical professionals are often individually powerless to combat the issue,

Hereby enacts the following:

1. No newly developed pharmaceutical drug will become available for public use by sapient individuals, either with or without prescription from a medical professional, unless it has undergone a clinical drug trial.
   
   
2. No individual is to participate in a clinical drug trial as a test subject unless all known dangers associated with participating in the trial have been communicated to and understood by the subject.
   
   
3. Clinical drug trials will involve the testing both of the drug in question and of a comparable drug designed with an equivalent purpose and available for public use in the target locations, if such a drug exists. However, if no such drug exists, or if the clinical trial is being conducted for the purpose of testing for side-effects, a placebo is to be used instead of or as well as this second drug. The sample used for the drug in question will be equal in size to that used for the second drug or placebo, and will be selected using the same method and requirements.
   
   
4. The individuals participating in the trial as test subjects, administering substances for the trial, or collecting data directly from the test subjects will not know during the trial which substance each test subject is receiving.
   
   
5. If the drug in question is being compared to a second drug, the two will be administered in equivalent dosages and with equivalent regularity, so that neither has an inherent advantage in performance over the other arising from the methodology of the trial.
   
   
6. Should the drug in question become available for public use, either with or without prescription from a medical professional, information about all clinical trials conducted on it — to include methodology and complete results — must be available for viewing by consumers and medical professionals, readily and free of charge.
   
   
7. The World Health Authority Health Research and Development Division (HRDD) is charged with collaborating with member states and entities within them to promote scientifically responsible and unbiased clinical drug trials and the widespread dissemination of their results, as well as investigating cases of potential noncompliance with this resolution.
   
   
8. Where it is proved to the HRDD that clinical trials for a particular drug as carried out according to the mandates of this resolution would not be scientifically meaningful, the HRDD will allow the trial to take place following an alternative methodology that nevertheless ensures as complete transparency and absence of bias as possible.

Rigorous Trialling of Medication

Category: Health | Area of Effect: Research

The World Assembly,

Asserting that without clinical trials, newly developed drugs may have profoundly damaging and unforeseen effects on patients,

Aware that in many cases, pharmaceutical companies benefit financially from positive clinical trial results for the drugs they produce, as these may lead to more sales,

Regretting that as a result these companies seek to conduct clinical trials in such a way as to ensure outcomes which portray their drugs well, instead of seeking to maximise scientific discipline and rigour,

Appalled furthermore that the manipulation by companies of public perception of their drugs, by choosing selectively which data are made publicly available, may be unregulated at the national level, and

Dismayed that this has a huge detrimental effect on the effective treatment of countless patients, and that medical professionals are often individually powerless to combat the issue,

Hereby enacts the following:

1. No newly developed pharmaceutical drug will become available for public use by sapient individuals, either with or without prescription from a medical professional, unless it has undergone a clinical drug trial comparing it with a second drug or with a placebo as per clause 3.a. of this resolution.
   
   
2. No individual is to participate in a clinical drug trial as a test subject unless all known dangers associated with participating in the trial have been communicated to and understood by the subject.
   
   
3. 1. Clinical drug trials will involve the testing both of the drug in question and of a comparable drug designed with an equivalent purpose and available for public use in the target locations, if such a drug exists. However, if no such drug exists, or if the clinical trial is being conducted for the purpose of testing for side-effects, a placebo is to be used instead of or as well as this second drug. The sample used for the drug in question will be equal in size to that used for the second drug or placebo, and will be selected using the same method and requirements.
      
      
   2. The individuals participating in the trial as test subjects, administering substances for the trial, or collecting data directly from the test subjects will not know during the trial which substance each test subject is receiving.
      
      
   3. Dose comparison trials involving only one drug are exempt from this clause of this resolution.
   
   
4. If the drug in question is being compared to a second drug, the two will be administered in clinically standard dosages and with clinically standard regularity, so that neither has an inherent advantage in performance over the other arising from the methodology of the trial.
   
   
5. Should the drug in question become available for public use, either with or without prescription from a medical professional, information about all clinical trials conducted on it — to include methodology and complete results — must be available for viewing by consumers and medical professionals, readily and free of charge.
   
   
6. The World Health Authority Health Research and Development Division (HRDD) is charged with collaborating with member states and entities within them to promote scientifically responsible and unbiased clinical drug trials and the widespread dissemination of their results, as well as investigating cases of potential noncompliance with this resolution.
   
   
7. Where it is proved to the HRDD that clinical trials for a particular drug as carried out according to the mandates of this resolution would not be scientifically meaningful, the HRDD will allow the trial to take place following an alternative methodology that nevertheless ensures as complete transparency and absence of bias as possible.

The World Assembly,

Asserting that without clinical trials, newly developed drugs may have profoundly damaging and unforeseen effects on patients,

Aware that in many cases, pharmaceutical companies benefit financially from positive clinical trial results for the drugs they produce, as these may lead to more sales,

Regretting that as a result these companies seek to conduct clinical trials in such a way as to ensure outcomes which portray their drugs well, instead of seeking to maximise scientific discipline and rigour,

Appalled furthermore that the manipulation by companies of public perception of their drugs, by choosing selectively which data are made publicly available, may be unregulated at the national level, and

Dismayed that this has a huge detrimental effect on the effective treatment of countless patients, and that medical professionals are often individually powerless to combat the issue,

Hereby enacts the following:

1. For the purposes of this resolution, a "double blind procedure" is defined as a procedure in which the individuals participating in a study as test subjects, administering substances for the study, or collecting data directly from the test subjects do not know during the study what substance each test subject is receiving.
   
   
2. For the purposes of this resolution, a "clinical drug trial" is defined as a study performed using a double blind procedure for the purpose of determining the effects of a newly developed pharmaceutical drug. It involves the testing of the drug in question and:
   
   
   1. a comparable drug designed with an equivalent purpose and available for public use in the target locations, if such a drug exists, for determining the efficacy of the drug - if not, a placebo is to be used, and
      
      
   2. a placebo, to be used for determining side-effects of the drug.
   In a clinical drug trial, the sample of patients trialling the drug in question is equal in size to the sample of patients trialling the second drug or placebo in each of the above cases, and is selected using the same method and requirements.
   
   
3. No newly developed pharmaceutical drug will become available for public use by people, either with or without prescription from a medical professional, unless it has undergone a clinical drug trial.
   
   
4. Subject to extant World Assembly resolutions, no individual is to participate in a clinical drug trial as a test subject unless:
   
   
   1. all known dangers associated with participating in the trial have been communicated to and understood by the subject or their legal guardian, where the subject is legally unable to consent to participation, and
      
      
   2. 1. the subject is legally able to consent to participation in the trial, and has done so free from coercion or threats, or
         
         
      2. the subject is legally unable to consent to the participation in the trial, their legal guardian has done so free from coercion or threats, and the potential benefit arising from the subject's participation unambiguously outweighs the risk of harm to the subject.
5. If the drug under investigation in a clinical drug trial is being compared to a second drug, the two will be administered in clinically standard dosages and with clinically standard regularity, so that neither has an inherent advantage in performance over the other arising from the methodology of the trial.
   
   
6. Should the drug in question become available for public use, either with or without prescription from a medical professional, information about all clinical trials conducted on it — to include methodology and complete results — must be available for viewing by consumers and medical professionals, readily and free of charge.

[Imperium Anglorum]

Your link to GA 82 – http://www.nationstates.net/page=WA_pas ... s/start=81 – is wrong.

[Maowi]

OOC: Oh dear, not quite sure how that happened. It should be fixed now.

[Desmosthenes and Burke]

If the drug in question is being compared to a second drug, the two will be administered in equivalent clinically standard dosages and with equivalent clinically standard regularity, so that neither has an inherent advantage in performance over the other arising from the

OOC:
Since I am assuming you do not want to kill the test subjects or prohibit clinical trials on humans altogether, suggestion in red. Obviously, I care not at all about the specific language, but I think it needs to be clear you want them to compare normal dosages of the two drugs, not literally equivalent numbers of milligrams of two drugs (which would be stupid beyond belief).

[Honeydewistania]

"The current draft has omitted the provision from #82 which requires the consent of participants to be obtained before undergoing a clinical trial, an oversight of which we feel must be corrected."

[Maowi]

OOC:
Since I am assuming you do not want to kill the test subjects or prohibit clinical trials on humans altogether, suggestion in red. Obviously, I care not at all about the specific language, but I think it needs to be clear you want them to compare normal dosages of the two drugs, not literally equivalent numbers of milligrams of two drugs (which would be stupid beyond belief).

OOC: Indeed, that was my reasoning for choosing the word "equivalent" over "equal". You're right that it's best to avoid ambiguity as clearly as possible though so thank you for the suggested language, I have put it into the draft.

"The current draft has omitted the provision from #82 which requires the consent of participants to be obtained before undergoing a clinical trial, an oversight of which we feel must be corrected."

"Rest assured that this was not a decision taken thoughtlessly, ambassador. Since the passage of GA#82, this assembly has passed a Medical Research Ethics Act which enacts that mandate in its "requires" clause.

"Separately, I have also made a change to ensure that dose comparison trials are not unreasonably hampered by these regulations."

[Araraukar]

OOC: Why is there no main clause to clause 3? The "subclauses" in it should be free-standing clauses of their own right as there's nothing binding them together. And given that #1 refers to "3.a.", why not just move that "subclause" to clause 1? Just move clause 2 hout of the way (it doesn't specifically have to be where it is now).

Alternatively, which I feel is what you might want to do, so take clause 3.a. and open it up into a main clause and subclauses. It's information-dense and hard to parse currently. It would with some re-wording actually wor as a definition for "clinical drug trial". If you define that term with all the ingredients you list must be in a clinical trial, put that at the start of the proposal, then you can streamline current clause 1 (at least).

In 3.b. I think you're trying to explain double blind procedure? I suggest actually using "double blind procedure" as a term and defining it (again, the ingredients for the definition are in that "sub"clause), if you think you need it. Currently I don't see a need for it in the proposal, but you could include it in the definition of "clinical trial" if you defined "double blind procedure" first, and then added it into the ingredients of the definition of "clinical trial".

Current 3.c. should DEFINITELY be a freestanding clause as it's an important clarification. Though, I'm not entirely certain why it exists? Why would dosage trials not be clinical trials? To my knowledge they're done as double blind procedure as well, and follow the same rules and regulations as pristine drug test clinical trials.

Not entirely certain what the committee is needed for, if you make a water-tight definition for clinical trial that includes all the things you want it to include, and then make it so that the clinical trials are needed for medications to become publicly available. Then the committee would not be needed at all as there's no need to promote what is required.

I also don't quite understand the point of clause 7. Can you give an example of what might be clinically trialled without being a clinical trial?

[Maowi]

OOC:

OOC: Why is there no main clause to clause 3? The "subclauses" in it should be free-standing clauses of their own right as there's nothing binding them together. And given that #1 refers to "3.a.", why not just move that "subclause" to clause 1? Just move clause 2 hout of the way (it doesn't specifically have to be where it is now).

Alternatively, which I feel is what you might want to do, so take clause 3.a. and open it up into a main clause and subclauses. It's information-dense and hard to parse currently. It would with some re-wording actually wor as a definition for "clinical drug trial". If you define that term with all the ingredients you list must be in a clinical trial, put that at the start of the proposal, then you can streamline current clause 1 (at least).

In 3.b. I think you're trying to explain double blind procedure? I suggest actually using "double blind procedure" as a term and defining it (again, the ingredients for the definition are in that "sub"clause), if you think you need it. Currently I don't see a need for it in the proposal, but you could include it in the definition of "clinical trial" if you defined "double blind procedure" first, and then added it into the ingredients of the definition of "clinical trial".

Current 3.c. should DEFINITELY be a freestanding clause as it's an important clarification. Though, I'm not entirely certain why it exists? Why would dosage trials not be clinical trials? To my knowledge they're done as double blind procedure as well, and follow the same rules and regulations as pristine drug test clinical trials.

Thank you very much for the feedback on the structural aspect of it. I've tried to do a re-shuffle of it with definitions to hopefully make it a bit more readable - I'm not sure really which version is better so your view on that would be very helpful to me.

Not entirely certain what the committee is needed for, if you make a water-tight definition for clinical trial that includes all the things you want it to include, and then make it so that the clinical trials are needed for medications to become publicly available. Then the committee would not be needed at all as there's no need to promote what is required.

I also don't quite understand the point of clause 7. Can you give an example of what might be clinically trialled without being a clinical trial?

I've also gotten rid of the committee sections. I think the part I had in there about making the results of clinical drug trials widely available was the most important thing in there for me, but I think that should be pretty much covered by my now-clause 6.

[Maowi]

OOC: Bump! I would love to hear more thoughts on this. And comments on the repeal draft would also be great.

[Boston Castle]

"Ambassador, I think your proposal is really well thought out, but I might suggest 'by sapient individuals' in Clause 3 is not necessary."

OOC: Welcome back to the GA, Maowi! :giveheart:

[Maowi]

"Ambassador, I think your proposal is really well thought out, but I might suggest 'by sapient individuals' in Clause 3 is not necessary."

OOC: Welcome back to the GA, Maowi! :giveheart:

"Thank you, ambassador. If I end up needing to cut down the proposal I will certainly bear that in mind but since there is plenty of space for now I prefer to stay on the safe side."

OOC: Thankee Hull!!! <3

[Kenmoria]

“In clause 2, I don’t think you can use the word ‘both’ when you are referring to a probable three items.”

[Maowi]

“In clause 2, I don’t think you can use the word ‘both’ when you are referring to a probable three times.”

"Thank you for that spot - I have removed the word."

[Maowi]

OOC: I'm bumping this one more time, would like to get it well on its way before getting the repeal ready to submit :)

[WayNeacTia]

I am almost sure that the new COVID vaccine coming out had nothing to do with inspiring this. Just wondering, if it is possible for someone to come up with an original idea every now and then?

[Separatist Peoples]

OOC: Drafts by newer players with negative comments from known antagonizers get my support.

[WayNeacTia]

OOC: Drafts by newer players with negative comments from known antagonizers get my support.

Hmmm. Did someone have an epiphany? I personally liked the old Sep better.

[Separatist Peoples]

OOC: Drafts by newer players with negative comments from known antagonizers get my support.

Hmmm. Did someone have an epiphany? I personally liked the old Sep better.

Ooc: Thank you for your kind words.

[Imperium Anglorum]

https://www.pfizer.com/news/press-relea ... te-against. 'Monday, November 09, 2020 - 06:45am'.

The OP. 07 Nov 2020 13:23.

Maowi should give me his time machine; I could make a lot of money buying stock options.

[Maowi]

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against. 'Monday, November 09, 2020 - 06:45am'.

The OP. 07 Nov 2020 13:23.

Maowi should give me his time machine; I could make a lot of money buying stock options.

OOC: I'll pass on that request to my science teacher posted this the day after they gave a lesson on the topic

[Maowi]

OOC: As with the repeal draft with which this would act as a replacement, I'm hoping to continue working on this and would love any more feedback!

[Hulldom]

OOC: As with the repeal draft with which this would act as a replacement, I'm hoping to continue working on this and would love any more feedback!

I’m guessing you’re referring to NPU’s repeal?

Edit: $10 so Hulldom can learn to read the front page of the subforum on his phone.

[Apatosaurus]

"Apatosaurus supports a repealacement of GAR#82, and has given the Maowese delegation some feedback:"

In a clinical drug trial, the sample used for the drug in question is equal in size to that used for the second drug or placebo in each of the above cases, and is selected using the same method and requirements.

"This is problematic if, for example, drug A's usual dose is smaller than the dose of drug B (which is being trialled) which is at that time believed to be the most effective."

[*]If the drug under investigation in a clinical drug trial is being compared to a second drug, the two will be administered in clinically standard dosages and with clinically standard regularity, so that neither has an inherent advantage in performance over the other arising from the methodology of the trial.

"Unless I am misunderstanding this, does this not contradict with Section 3?"

[Maowi]

"Apatosaurus supports a repealacement of GAR#82, and has given the Maowese delegation some feedback:"

"Thank you very much for both your support and your feedback, ambassador!"

In a clinical drug trial, the sample used for the drug in question is equal in size to that used for the second drug or placebo in each of the above cases, and is selected using the same method and requirements.

"This is problematic if, for example, drug A's usual dose is smaller than the dose of drug B (which is being trialled) which is at that time believed to be the most effective."[/quote]

"Ah, I see where the terminology we have used may be confusing - in this clause, "sample" is intended to refer to the sample of people participating in the trial. I have modified the language - I hope it is clearer now?"

[*]If the drug under investigation in a clinical drug trial is being compared to a second drug, the two will be administered in clinically standard dosages and with clinically standard regularity, so that neither has an inherent advantage in performance over the other arising from the methodology of the trial.

"Unless I am misunderstanding this, does this not contradict with Section 3?"

"Is this point a reference to it being impossible to have "clinically standard dosages/regularity" for a drug that is undergoing a trial and therefore is yet to have been used by the general public? If so, I will admit that had slipped past me and will think about replacing the phrase with something more suitable."

[Apatosaurus]

"This is problematic if, for example, drug A's usual dose is smaller than the dose of drug B (which is being trialled) which is at that time believed to be the most effective."

"Ah, I see where the terminology we have used may be confusing - in this clause, "sample" is intended to refer to the sample of people participating in the trial. I have modified the language - I hope it is clearer now?"

"Looks better now!"

[*]If the drug under investigation in a clinical drug trial is being compared to a second drug, the two will be administered in clinically standard dosages and with clinically standard regularity, so that neither has an inherent advantage in performance over the other arising from the methodology of the trial.

"Unless I am misunderstanding this, does this not contradict with Section 3?"

"Is this point a reference to it being impossible to have "clinically standard dosages/regularity" for a drug that is undergoing a trial and therefore is yet to have been used by the general public? If so, I will admit that had slipped past me and will think about replacing the phrase with something more suitable."[/quote]
"That is a good point, but that was more in reference to my (apparently mis)understanding of Section 4."