<p>Do Prostate cancer research at a Prostate Centre and Neurogenesis research at a Brain Research Centre fall into clinical research or just bench (hard sciences) research?</p>
<p>Will you see patients and be rounding with doctors? If so - clinical.</p>
<p>My research that I'm doing this summer consists of "research days" (analyzing patient progress to a particular treatment, doing lab-work, etc) and "clinical days" (essentially I'm a shadow and the M.D. is actually an M.D.).</p>
<p>Will you be speaking to test tubes all day long? If so - bench research.</p>
<p>what if i test people by giving them activities to measure their brain function. i dont work with doctors because i work in a behavioral lab, but i do work with people, not test tubes or rats</p>
<p>Ysk1,</p>
<p>Researchers can work either in animal models or cellular models of disease, which would be preclinical research.</p>
<p>If you are working in Clinical Research, at some part of your Program, you would have to come in contact with either the planning, execution, or reporting of a "Clinical Trial" which involves patients, may it be a Ph2a, Ph2b, Ph3, or Ph4 trial.</p>
<p>Hope that helps. IM me details if you wish to discuss this off-line.</p>
<p>Oh! By the way, the phases of clinical research are defined as below (with the exception of Oncology and Transplantation therapeutic areas).</p>
<p>Phase 1 - Clinical Pharmacology- the drug is tested in healthy volunteers (HVs) to understand the absorption, distribution, metabolism, and excretion of the drug in the body (in other words Pharmacokinetics). One can also assess the MTD (Maximum tolerated dose in HV), and drug-drug interactions, as well as some signal of Pharmacodynamics (whether the drug works!)
Phase 2 a trials - consist of Proof of Principle (PoP) studies - where you can evaluate the drug either in the patient population or in population that is closest to patient population (sometimes by simulating the disease state temporarily) to see if the drug mechanism actually works!
Phase 2b - Proof of concept (PoC) studies - Once you have a positive signal from a PoP study, you move on to PoC studies, where you test the drug in a patient population study to see the disease outcome (for Alzheimer's disease for example, you may administer the drug for 6 mos to a year and look for symptomatic effect, ie cognitive benefit).
Once Phase 2b studies prove positive (and hopefully do not have any Serious Adverse Events), you progress to Ph3</p>
<p>Phase 3 - are long term studies (either as long as Ph2b or longer) in a much larger patient population, are generally global studies. You need positive outcome that is acceptable by FDA's regulatory body in that specific therapeutic area branch.</p>
<p>This is the timepoint for NDA submission and FDA approvals.</p>
<p>All studies done thereafter are Ph4 studies. Ph4 studies provide new indications, allow teams to come up with more optimized formulations.</p>
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Will you see patients and be rounding with doctors? If so - clinical.
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<p>wrong</p>
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If you are working in Clinical Research, at some part of your Program, you would have to come in contact with either the planning, execution, or reporting of a "Clinical Trial" which involves patients, may it be a Ph2a, Ph2b, Ph3, or Ph4 trial.
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<p>misleading </p>
<p>first of all clinical research does not necessarily involve contact with patients...you can create a hypothesis, collect data and test it all without ever seeing a single patient. </p>
<p>There are two types of clinical research: observational and experimental. Pharmagal explained one example of an experimental study but experimental studies do not have to involve drugs but can involve any sort of intervention. Observational studies are where there is no intervention but you are seeing what kind of effect an exposure has on a group of people or what kind of exposures exist more commonly in a certain diseased population.</p>
<p>Most clinical research doesn't involve any significant patient contact for those actually analyzing/conducting the research (i.e. not a nurse collecting patients tissue samples or blood). For instance, a oncologist may be studying the genetic basis of a particular type of cancer. Certainly if it's a rare form (or even a common form), he/she will want large sample numbers that won't be available within his/her own patient base. And generally, if he/she runs a lab, they probably have much fewer patients than a regular physician who works full-time in clinic (most physician-scientists work about 1/2 day a week in clinic). Thus, most of these situations just involve the lab of doctor/phd receiving tissue samples from the patients of colleagues (from both near and far) and analyzing them for genetic indicators (in the example of cancer genetics). Most often, there's actually very little patient contact. I'm a full-time research assistant, and one of my many lab side projects is considered clinical research. I receive tissue samples from patients with various types of childhood diseases (type I diabetes, sickle cell anemia, etc.) in the hospital and I convert them to iPS stem cells for further study in our lab or another lab. We never see patients, just samples. And, that's the case for most labs in my department.</p>
<p>As an undergrad, unless you find a really interesting clinical research project, I'd say it's probably much more intellectually rewarding to join a basic science lab. Mass scale clinical research often comes down to assessing pretty mundane and repetitive tasks. You don't want to be analyzing 100 patient samples a week looking for single point mutations. Believe me, it will get old. If you want clinical experience as an undergrad without medical training, I'd suggest looking into public health projects that may involve a lot of one on one patient interaction.</p>
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I'm a full-time research assistant, and one of my many lab side projects is considered clinical research. I receive tissue samples from patients with various types of childhood diseases (type I diabetes, sickle cell anemia, etc.) in the hospital and I convert them to iPS stem cells for further study in our lab or another lab.
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<p>this is still lab research...you are taking a sample and performing lab techniques ....no clinical research at all there.... yes, the samples may be eventually used for clinical research but you have no part in that aspect of the research</p>
<p>also to even call that task "research" is using a pretty loose definition</p>
<p>do some real research in the basic sciences.</p>
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do some real research in the basic sciences.
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<p>suggesting that "real" research has to be in the basic sciences is naive and ignorant</p>