Clinical Trials Career Guide and Counseling

Question: what percentage of clinical trials ultimately result in an effective drug? I know it takes a while to go through with a clinical trial (10-15 years?) but how many of those clinical trials fail and how many result in production of a drug? Thank you!

Answer: About seven to fifteen years. The shortest time I've ever heard of a drug going from lab to actual use was the original HIV protease inhibitor, at the time there was essentially no treatment for HIV/AIDS, and a diagnosis usually meant death in under a year. The FDA basically pulled out all the stops for it. There's three phases of clinical trials, and precliical before that. The overwhelming majority of drugs die in preclinical trials. About 7-9% of what gets into Phase I trials gets to move forward. It's hard to go with an exact number, because high throughput drug screening - which is where they test a very large number of compounds looking for a specific behavior skews it. Of he compounds that are looked at seriously though, easily under 1% make it to the point where they can be sold.

Question: How do I find the best paying clinical trials available? My husband lost his job, we have 5 kids. I am looking into clinical trials for payment. How do I find the best ones out there?

Answer: The best paying ones are for the dangerous drugs and surgical procedures. The highest paying one right now is at the University of Cincinnati, it is an experimental surgery for an exterior-mounted uterus. It will pay $35,000 in the first year, and will pay $20,000 in each following year, for up to 10 years. Your uterus will be re-positioned whenever you drop out, even if you drop out early. There is a less invasive one at UNLV for a cerebellum-implanted gambling chip, but you have to have a history of problem gambling. It paid $18,000 flat fee up front, but they jacked it up to $20k when they learned about the vomiting side effect. Your best bet is to figure out all the ways you are unusual and start googling.

Question: Where can I find information on clinical trials? I need a site with information on clinical trials so that I coould write a report on it. Please help?

Answer: Try: http://www.clinicaltrials.gov/

Question: What are the factors that make the clinical trials the most reasonable means to test a new medical devices? I knew that apart from testing new drugs, clinical trials are also used to ascertain the effectiveness and safety of a new medical devices such as implants, prostheses.. etc . But what are the factors that make the clinical trials the most reasonable means to test a new medical devices?

Answer: we've had one lecture on this......the points that i managed to pick up is that clinical trials are good if they are randomised, double-blinded and placebo-controlled. because then the trials can be generalised to the targeted/normal population.

Question: What research has been done about the affect of clinical trials? I am looking for thinks like website, interviews, and etc. These things should describe what clinical trials should be like and what they are like sometimes. Lawsuits and companies involved in them well be greatly appreciated.

Answer: Money, lax ethics and clinical trials http://www.cspinet.org/integrity/regulate_frank.html Following has many links to good articles such as children in cllinical trials. https://www.worstpills.org/results.cfm?keyword_id=44 Ethical reviews of clinical trials http://www.slate.com/id/2132187/ How to keep your clinical trial lawsuit free http://www.irbforum.com/forum/read/6/56/56?PHPSESSID=46f2d0a6ba60e3797b25b1ce0a0769e8

Question: What is the most effective way to enroll in clinical trials for new drugs against Leukemia? I am currently Gleevec resistant and need to get involved in clinical trials for Leukemia (CML). Thanks for all your suggestions!.

Answer: So sorry. I think a good place to start would be to check leukemia or cancer organizations online to see if they list any resources or have news of experimental treatments and contact the doctors/hospitals directly. Hope this helps and you get well soon.

Question: What do you know about clinical trials? My mom just received the news that her breast cancer has spread to her lungs and liver. The standard chemo did not kill all the cells. She is now Stage IV metastatic breast cancer. It is inoperable at this point. So, now her doctors want her to participate in a clinical trial for Sutent. I've been to many sites about clinical trials. What I'm asking for here is personal experience (either yourself, a friend, or loved one) with clinical trials, specifically for cancer treatment. Thanks in advance.

Answer: Inverse, not completely correct,. Clinical trials do still have a placebo in some cases, and it is ethical because there is not proof the study drug will be better than placebo. Most clinical trials do not though have a placebo ONLY arm. Phase III trials are generally randomized, controlled trials comparing the top contender with the current champion. All patients get treatment, some may get something extra, or may get something completely different ( e.g., A vs B or maybe A + B vs A). The point is to see if the contender is better, in which case it will become "champion", otherwise the champion continues reign. Phase II trials are not usually randomized, and patients generally know going in what they will get. In a phase III study, a computer determines which arm of the treatment you will get; that is OK because the researchers have pre-determined that each of the arms are equivalent to the best of our knowledge currently-- they are trying to see whether that assumption is correct or not. Phase I trials are quite experimental. Patient access is limited, and here mostly what is being accomplished is determining the dose and side effects/tolerance. If your mother is newly diagnosed as stage IV, she should not be on a phase I trial. II or III are reasonable, and III would be preferred. Sutent is an exciting new agent, but she has numerous options, both on trial and standard off-trial options. She needs to fully explore her options with her oncologist and go with the one she is most comfortable with based on prospects for response, toxicity, convenience, etc. God bless. best wishes

Question: How long do clinical trials and fda approval for a vaccine take? How long are phase II clinical trials?

Answer: Phase II clinical trials range in length but usually take 6 mos - 3 years depending on the drug and the condition. Phase III usually takes longer as there are many more patients involved. Overall, from the time a drug enters Phase I clinical trials to when it is approved can be 1-10 years. If it is for a really bad condition that doesn't have many therapeutic choices (things like cancers, etc) then the process is shortened a bit due to demand for new drugs. You can learn more about the drug approval process at http://www.clinicalconnection.com

Question: how do you find legitimate clinical trials to join in your area? how do I find non-scam clinical trials in my area, Colorado, to make extra money?

Answer: clinicaltrials.gov

Question: The best way to start a career in clinical trials? I live in the uk and hold a degree in biology. I'm very interested in the clinical trial field and was wondering the best way to enter the industry as all of the jobs i've seen thus far ask for some experience? Any help would be much appreciated.

Answer: www.biotrax.co.uk might be of help

Question: Do you think it is appropriate for pharmaceutical firms to conduct most of its clinical trials outside the US? Do you think it is appropriate for pharmaceutical firms to conduct most of its clinical trials in less developed countries? Do you believe that those positive aspects outweigh potential problems with clinical trials overseas? Should the US government become more involved in regulating these practices? I am curious what you think of this topic

Answer: I think the Gobblement should be less involved. There is no free market in medicine and the pharmaceutical industry has gained so much power over our lives exactly because of government regulation that gets rid of their competition. People need to learn to tie their own shoes again. If you told anybody 10 years ago that fish oil is very beneficial and can help with heart disease you'd be called a quack and jailed (And probably still would be today, since only a pharmaceutical company that has a patent on a compound can make lots of money and conduct large clinical trials which the FDA will then approve. And even there is much fraud going on. Revolving doors...etc.) There is no freedom of speech in health care. We have to stop this FDA, AMA etc. regulated, medical industrial complex which brainwashes people and limits our choices and ultimately eradicates, or has eradicated, personal responsibility in health care. You know, pop a pill and be fine. LOL! That's what our health care industry teaches us. The people of the USA have become a bunch of legal drug addicts!

Question: If a vaccine has made it to human clinical trials does that deff. mean at some point it will be passed? If they do find an issue in clinical trials will they automatically remove it or will they work out the issue and move on until it is passed? Also, roughly how long do clinical trials take to complete?

Answer: It depends on the issue. By no means does everything that makes it to human trials, regardless of phase, get approved. If a major issue is found, it generally means starting over from scratch (that is designing a new vaccine from the ground up, throwing the old one away), or making significant changes in formulation, either will involve redoing a lot of preclinical work, as well as the human trials. The length of a trial for a vaccine is substantially longer than that for most drugs. A period of a full year, all the way up to six years is where most would fall, depending on what the vaccine is designed to cover. From when the study is complete, it can take between several months to a year or longer for the data to be published in a scientific journal, and reviewed by the FDA. FDA review takes some time as well - for drugs it's generally around three months to a year. It depends on the urgency of the disease, and how much data there is to review.

Question: Anyone know where they do fertility clinical trials? I am having issues getting pregnant again after miscarriage. I can not afford a fertility specialist. Does anyone know where they do clinical trials in Florida about this?

Answer: Go to clinicaltrials.gov

Question: Has anyone any advice on how to gain employment as a Clinical Trials Administrator? I am a Secretary/PA and have previously trained as an Operating Department Assistant and worked in the States as a Surgical Technician, also trained and worked as an Emergency Ambulance Technician. But would like to gain employment in Clinical Trials in an Administrative capacity, but have not been able to find employment as qualification as CTA or experience is needed. Am happy to pay to go on a course, or start off at entry level.

Answer: Assuming you're in the UK search for clincal trials co-ordinator NHS website (it found me 4 or 5 jobs) - if you look at person specification within each post it will tell you what they are looking for. http://www.jobs.nhs.uk

Question: i want to know the procedure of clinical trials? i want to know where clinical trials are done,how many people are involved in this procedure,what are the qualifications required?

Answer: It depends on what you are trying to study, and when you say "people involved" whether you are talking about patients or healthcare workers. Either way, you are talking between hundreds to thousands of people. Phase 1: Safety studies Phase 2: safety primarily, with efficacy studies Phase 3: Primarily efficiacy studies Phase 4: post market surveillance Phase 5: Rejuvenation Qualifications depend on what is being looked at. You may need doctors, nurses, and specialists, not counting clinical liasons, Ph.Ds etc,. You could write a book, and several are written, on this topic.

Question: Where can I find a list of clinical trials in my area? I'm trying to find a list of clinical trials in my area, which is Arkansas.. that's studying ADD, ANXIETY, OR DEPRESSION.

Answer: They are advertised in the classifieds