Volunteer Statement And Registration Therefore, In: Fill & Download for Free

IntroductionEndpoints in a clinical trial are things that can be measured during the trial, to quantify if the objectives of the trial are met or not.The scientific integrity of the trial and the credibility of the data from the trial depend substantially on the trial design. Therefore, in the description of the trial design (usually the clinical study protocol / CSP), specific statements regarding the primary endpoints and the secondary endpoints should be included, to be measured during the trial. See also ICH GCP E6 R2.In order to apply statistics to the study results to help interpret the results, your endpoints need to be measurable. It is probably easiest to give some examples:1. Phase 1 first in human studyIf a drug has never been tested in humans before, the primary objective of the First-in-Human (FiH) study is likely to characterize the safety of the drug when starting with very low doses in a small number of healthy volunteers / patients, and slowly increasing the dose until toxicities are observed.In order to measure how safe the drug is, the primary endpoints of this study would include for example the number of Serious Adverse Events (SAEs) that are reported by the investigator to be suspected related to the drug.Typically, the CSP would specify how many of these events can be observed before a specific dose is considered toxic. The next lower dose would then be called "Maximum Tolerated Dose" or MTD.Obviously, the above is a gross simplification of the actual CSP, but you probably get the idea.2. Phase 3 pivotal registration studyIf a drug has shown acceptable safety in early studies and a phase 2a study has shown that the drug has promising efficacy, a pivotal phase 3 study could be designed to confirm efficacy and furhter characterize the safety profile of the drug.Depending on the patient population, the availability of alternative treatments, and other factors, the results of two identical phase 3 studies showing significant evidence of efficacy and acceptable safety is sufficient to get a drug registered.Therefore, the primary objective of such studies could be to show that drug A is better than existing drug B. The way this could be measured could be in terms of the amount of time it takes for the existing disease to progress (e.g., tumor grows again in cancer patients). If the tumor in patients with drug A would take on average 2 years to start growing again, but in patients with drug B it takes less than a year, obviously, drug A is likely to be much better than drug B.Depending on how many patients were inlcuded, and how much variability in this progression-free survival (PFS) time is observed, the difference between drug A and drug B is statistically significant.Who decides…As highlighted by another person, the scientists who write the CSP "decide" which endpoints are measured during the study. Obviously, if medical doctors in the hospital write the CSP, it is they who decide. If the study is run by a pharmaceutical company (sponsor), it is either the sponsor alone, or the sponsor in combination with experts in the field (i.e., professors in university hospitals) who decide together. And if the study is designed to support the registration of a new drug, then the company will usually consult with health authorities (FDA, EMA, etc) to understand if the chosen endpoints are acceptable for these health authorities.ConclusionThe endpoints (both efficacy and safety endpoints) of any clinical trial are the most important aspects of the study, as measuring these will determine the fate of the study. Therefore, they are the most exciting to discuss and will have a huge impact on the strategy.

I’m going to offer you some advice that doesn't answer your question but will help out with what seems to be your ultimate goal: to get out of a ticket.Before I go on let me tell you that the advise I am offering you will most likely cause you short term headache but long term relief. It’s not for the faint of heart and if you’re the kind of person that wants to get out of being stopped by police as quickly and cooperatively as possible, then this is not for you.Basically if all you did was speed your choices are a five minute stop where you’ll have to have money taken out of your pocket later or a potentially 30 - 45 mins stop where you keep all your money and win in court. They have made this system of traffic stops convenient to allow your rights to be violated so that you'd much rather have that happen than stand up for them. Simply out, so that you’re willing to trade your rights for convenience.First, before I say anything else, always remember this: A.B.R.Always. Be. Recording.Record every encounter with the police. Preferably have more than one device recording so you have a backup. Your smart phone works, but also having a dash cam of your own is a good idea. The more the better. As soon as you’re pulled over, get it ready and start recording immediately.The first thing you should do when an officer pulls you over is politely ask their name (and maybe even their badge number). If you can see it on their uniform, simply state it out loud by address the officer as such so it has been recorded for your record. It’s also a good idea to always address the officer by his name on the rare occasions you do say anything (see below) because it only strengths your case.That out of the way, the biggest mistake people make when they’re pulled over is they talk to the police or answer their questions. Understand that just about every police officer in the country is trained to escalate a traffic stop into something more serious, most hopefully from their perspective an arrest (usually a drug arrest or a DWI). They don’t give a damn about the traffic violation, that’s just their pretense/cause for pulling you over in the first place. This is why they ask questions like “Have you been drinking tonight?” or “is there anything in the car I should know about?” or “do you have any weapons with you?”Exercise your right to remain silent. Never volunteer information. Do not incriminate yourself. If you must say anything simply say “I am going to exercise my right to remain silent, sir/ma’am” or “Am I required to answer your question?” (if they say “yes,” they’re lying and the fact they just lied to you could help your case later in court, especially since you've been recording and all cops have dash cams now that will record the entire interaction — but don’t count on their dash cam: again, A.B.R.!). Keep in mind: it’s better to say nothing than anything else because you may say something that you think it’s totally benign but actually incriminates you. You’d be surprised what they can twist into an incriminating statement. They’re highly trained to do this.Now, remember what I said about this not being for the faint of heart? This is what I mean, because police are used to citizens simply rolling over and this could frustrate/anger them and/or at the very least raise suspicions you’re hiding something. It means they’re going to give you a hard time. They may even call for back up. Just exercise your right to remain silent.Now that the escalation questions are over let’s talk about how to handle the questions intended to incriminate you about what you actually probably did: violate a traffic law. Since the most common thing people are pulled over for is speeding, let’s use that as the example.The officer that pulled you may ask “do you know why I pulled you over?”This is the classic and blatant attempt to get you to admit to breaking traffic laws and thus incriminate yourself immediately. That’s why it’s usually the first question they ask. They’re trained to do so.They might also ask “do you know how fast you were going?” or “do you know why I clocked you at back there?”The most acceptable answer is none. Remain silent. Do not answer these questions. At most say “no, sir/ma’am” or “Am I required to answer your question(s)?” or “I am going to exercise my right to remain silent.” Always be polite and respectful. Do not appear hostile or have a hostile tone. Remember: you are in the right, they are in the wrong as far as your rights go, but they also have guns, tasers, mace and handcuffs.Lots of people get themselves in trouble here because instead of keeping quite, they make exercises. A common conversation might go like this:Officer: “Do you know why I pulled you over?”Citizen: “I have no idea, sir.” (good so far).Officer: “Well, you’re in a 55 MPG zone but I clocked you going 65…”Citizen: “Oh, well I didn’t realize that sir. The rest of traffic was going that speed and I was keeping up with the flow of traffic.” (Excuse! Ut oh…)Officer: “That may have been the speed of traffic but regardless that does not change the fact that the speed limit is 55 MPG and you were going 65.”Citizen: “Well, Officer, I guess that’s true.” (Oops! Incriminated!)At that point, you’re done. So don’t answer the questions. The more you talk (or the more the officer gets you to talk, which is what they’re trained to do), the more likely you are to incriminate yourself.Now we get to the really sticky part that is not for the faint of heart.At this point he’s going to ask for your license and registration (and maybe proof of insurance, depending on where you live). According to the Constitution (Fifth Amendment protections), you are NOT required to provide him with ANY of these documents. Now the problem here is that there are unconstitutional state laws that say otherwise, but if you follow this that won’t matter.The right to remain silent is not just limited to the things you say, it is also a right to not provide anything that could be used against you in a court of law. Your license and registration could (and will) be used against you in a court of law and thus is is your right to not have to provide this documents.If you give them up voluntarily, he'll scan them and use them as evidence in court. If he takes them involuntarily (see below), then you can have that evidence suppressed in court so it cannot be used against you.Not only will these documents be used against you for the current reason the officer has pulled you over, let’s say you voluntarily provide your license and yesterday was your birthday and you haven’t been down to the DMV to review it. Now you have a driving with an expired license charge in addition to what he pulled you over for.Let’s say you you haven’t downloaded you new insurance card and it expired two weeks ago. He can charge you with failing to maintain financial responsibility on top of that.A lot of people mistakenly think they’ll go into their car and run the information and see that you’re all clear despite having expired documentation. They can do that, but they can make the charge and still force you to defend it in court, which costs you money even if you win. Why? Because even if you don’t hire a lawyer you’ll go to court with the proper documentation to prove you were insured and they’ll say “OK, charges dismissed, but you have to pay cost of court for us handling this case.” Cost of court is often more expensive than the actual fine for the ticket and this is by design because it’s all a racket to make money off of you and they know that when they pull most people they’re going to get at least that out of you. They're getting money out of you one way or the other.Don’t be like most people.Now, back to your license/registration/proof of insurance, when the officer asks for this information how do you respond?The answer is one that clearly shows for the record the reason why you're not going to provide the information you're being requested (i.e. that you’re exercising your rights).You politely say: "Officer ___________, can the information you are requesting be used against me in the court of law or be used to incriminate me in anyway?"That's a question relating to your 5th amendment protections. The answer is it absolutely CAN but up to that point he did not inform you of what your rights were.If he says "yes," which is the correct answer, then he has informed you that if you give this information voluntarily you will be waving your right to remain silent.If he says "no," he is lying, which will help you in court.The reason to do this is now you can show this was not a voluntary surrender of this information. Therefore that information can later be suppressed at trail when they attempt to use it against you because it was illegally obtained.Now what happens if he refuses to answer or gets belligerent?Follow up with the following:"Officer ________________, I believe the information can be used against me, therefore I invoke my right to remain silent. Do you intend to retaliate or punish me for simply invoking by my protected Constitutional right to remain silent?"Now he's on the hook because this will show he clearly understands what you just did and why you did it but you've been put in an illegal and unconstitutional position where you’re going to do what HE wants regardless of what your rights are. Thus he has violated your rights and you have a record of it.Most likely at this point two things will happen:1. He’ll realize what he’s dealing with and will not want the headache so he’ll let you off the hook with a verbal warning.-or-2. He’ll continue to insist that you have to provide this information and threaten you with punishment if you do not provide it (and/or insist you have to).If #2 happens, you have two options:Lay your information on your dash where he can reach it through the window and say: “Officer ______, I am placing the information that I believe could be used to incriminate me in court on the dashboard, however, I do not consent to you taking it and I am not voluntarily surrendering it. I am simply fearful that you will retaliate against me or punish me for simply trying to exercise my rights.” Most likely he will taken the information off the dash.Say essentially the same thing and then hand the information to him: “Officer ______, I believe could be used to incriminate me in court and wish to exercise my right to remain silent. I do not consent to you taking it and I am not voluntarily surrendering it. I am only surrendering it involuntarily out of fear and duress that you will retaliate against me or punish me for simply trying to exercise my rights.”This is not an easy thing to do. It can be scary, intimidating and even carry risk. But what price do you put on your rights? Personally, I have done this 3 times in my life (all three times I've been pulled over) and each time I have gotten out of everything without paying a time. Twice the cop simply let me go because he realized what he was getting into. The other time (most recently) he took my information off my dashboard after option #1 above and wrote me a ticket for speeding. I took it to court and told the judge what happened, presented my recording as evidence and explained the officer violated my rights (Note: this officer was particularly belligerent about my lack of cooperation). The Officer was in the court room and the Judge ripped him a new one and discussed all charges and waived the cost to court.So, this does work, but it’s not for the faint of heart. Goodluck!

The first vaccine against COVID-19 has been registered!Developed jointly by Gamaleya Research Institute and the Russian Defence Ministry, the Russian vaccine is the first to be registered against COVID-19.Representative imageBut but but…There’s a slight catch here - The vaccine went into first stage of trials on June 18th, 2020 and now it’s being registered as the first vaccine against COVID-19. The reasons I believe there could be certain efficacy related issues with the vaccine are-Russians are really competitive when it comes to the “firsts” of any kind. This has been pretty evident with Russia’s hustle of going into the space and targeting being ahead of the USA in this regardThe registration is conditional and phase 3 trials are underway, which effectively means that if anything goes wrong, the vaccine loses its registration and we lose a major chunk of hope of seeing the pandemic end anytime soonWHO initially said that it “hoped” that they (Russia) have tested the vaccine properly and post-registration the following statement came out- “We are in close contact with Russian health authorities and discussions are ongoing with respect to possible WHO pre-qualification of the vaccine, but again pre-qualification of any vaccine includes the rigorous review and assessment of all required safety and efficacy data," WHO spokesman Tarik Jasarevic told a U.N. briefing in GenevaVarious industry bodies and pharma organizations view the Russian rush to registration as putting national prestige before science and safetyHowever, there are a few reasons I believe that Russia may have given the breakthrough which was needed in the fight against COVID-19-Russia has been really active in the innovation circle of communication, space tech, information technology, etc. Their scientific prowess is hidden from nobody, and it’s probable that they may have been able to create a vaccine with the science & tech infrastructure and the innovation mindset they possessThe coronavirus vaccine showed immunity in ALL the volunteers of round 1 and 2 of testing. Although this isn’t a guarantee that the vaccine will be successful in round 3, but the results of round 1 and 2 show great potential of successWith all the controversy around COVID-19 and WHO’s potential pro-China stand, WHO now appears nothing more than a mouthpiece of China, and therefore, it’s entire narrative against the Russian vaccine doesn’t seem to hold groundAlexander Gintsburg, director of the Gamaleya National Research Centre, said that vaccine used inanimate particles created on the basis of adenovirus, according to Sputnik News. He addressed the concerns of vaccine affecting the receiver’s health saying that particles in question cannot multiply and thus, do not have the potential of triggering an infectionVladimir Putin, Russia’s President, publicly said that the vaccine underwent necessary tests and that his daughter has also received a shot of it, and is feeling well. Says a lot about the President’s belief on his nation’s scientistsThe Russian vaccine shall be administered in two stages and is said to provide immunity for two years. Let’s hope that this vaccine along with others under different testing phases may see success in future and the world tackles this pandemic head-on before the first half of 2021!