Clinical research
is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products, and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relief of symptoms in a disease.
Overview
The term clinical research refers to the entire biography of a drug from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the drug including its efficacy and toxicity are studied.
After this, the data obtained from the studies are submitted as an IND (Investigational Drug Application) to the regulatory authorities for permission to conduct human studies.
Human studies or the actual clinical trials are conducted in four phases. The first phase usually deals with the trial of the medicine in a few people, usually healthy volunteers. This is mainly targeted at identifying the safety, tolerability, and the general mechanism of action of the drug in humans. These are conducted in special places called CPUs (Central Pharmacological Unit) where participants receive 24hr medical attention.
The second phase usually deals with a population of about 50-500 people. This is an efficacy study. Also, the dose needed for the next phase is finalised. It is conducted in hospitals.
The third phase usually deals with the trial on more than 1000 patients. This phase is usually multi-centric and focuses on the effects on drugs in different ethnic groups, comparison with the standard drugs on the market and also study of the effect on the drug on different variants of the disease. Then, an NDA (New Drug Application) is filed to the regulatory authority containing the study data regarding permission to market the drug.
The fourth phase is usually conducted after the launch of the drug on the market. The aim is to identify newer and hitherto unknown adverse reactions, effects in different ethnic groups and newer therapeutic indications among others. The entire journey of a drug from lab to market may take approximately 12-18 years.
However, clinical research does not stop here. It continues throughout the lifetime of the drug to include post marketing surveillance where a periodic 'progress report' is submitted to the regulatory authorities once every 2 years after the drug is released into the market and also into Pharmacovigilance where safety of marketed drugs, biologics or medical devices are monitored.
The focus of clinical research is wide enough to include data management, medical writing, regulatory consultation, biostatistics to name a few.
The clinical trials are usually guided in the United States by the guidelines of the U.S. Food and Drug Administration and in the European Union by the European Medicines Agency.
Rajkumar G
asked:
"clinical research salaries."
Question posted courtesy of:
Top Contributor replied:
"Depends on the country you are in.Clinical Research Manager: United States $70,450 - 25th%ile $86,323 - Median $101,352 - 75th%ile"
taffeelion
asked:
"I'm finding this very difficult as I am viewed as overqualified for an entry level position, but underqualified for higher level positions because I have no clinical research experience. My goal is to be a clinical trials project manager. I need good advice. Thanks!"
Question posted courtesy of:
Lady M replied:
"I would hate for you to have to downplay your PhD. Where have you been applying? Have you tried contract research companies (they run trials for companies). Pharmaceutical companies may also have their own staff and would probably be more open to highly educated people as yourself, as they generally pay well.Are you networking? After earning an advanced degree I would expect you to have some contacts in your field. If not, trying contacting appropriate managers at companies you are targeting and ask if they would grant you an informational meeting. Just be up front and tell them that this field interests you and you want to learn more about it. I'll bet if you targeted 10 companies you would find at least 3 managers willing to talk to you for 15-20 minutes in such a "no obligation" situation. They may even decide they like you and keep you in mind when they have an opening! Good luck."
biogirl_79
asked:
"I have a biology degree and I have worked in various labs doing research. I would like to move into the direction of clinical research monitoring sites and all that goes along with that job. The only problem is every open job posting wants you to have at least one years experience. How do I get experience?"
Question posted courtesy of:
ali replied:
"Try doing an internship?"
Brian S replied:
"understudy"
ChrisB replied:
"In my opinion, there are a few ways to break into a CRA role.1) Go through a temp agency, where the criteria may be lowered. The drawbacks are usually no vacation time and no insurance.2)Take a job as a CDA (clinical data associate). A CDA basically cleans the data coming in on the CRF (clinical research form) and issues queries. This would give you the "pharma experience" to move either internally to a CRA position and then onto CRA'ing for a pharma company, or directly to a pharma company.These positions are usually more easily found at CRO's (clinical research organization) companies, which work for the pharma industry. These companies bid on trials and then manage the data management and the monitoring. They are generally as not as nice to work for as the pharmaceutical companies: more hours, less pay. But they do give you benefits (i.e. vacation, retirement, profit sharing, health insurance)Final Recomendations:Be aware that a CRA is a job in which you will have to travel a great deal until you are senior enough. It is the ultimate road warrior job. If they say 50-60% travel they mean 80-90%Once you are in the clinical trial world, look into becoming accredited through SOCRA or ACRP. If you have problems getting a job and are serious look at getting your RN license you then become very marketable in most regions and can either work for the site or the pharma company.A lot of the above is contigent on you living in an area where there are numerous CROs, and pharmaceutical companies. East Coast (i.e. research triangle), Chicago area, West Coast (San Diego, San Francisco). If you don't then it will be more difficult but if you are willing to be on the road 80% or more of the time, then moving shouldn't be a big problem. Google for pharmaceutical companies, clinical research organizations, device companies etc... in your area.The big CROs I know of are: Quintiles, Covance, and KendleGood Luck!"
roshanmon
asked:
"I am a Registered nurse who is planning to do my Graduate Diploma in Clinical Research from Melbourne University.I woulod like to know about the job oppourtunities and pay scale for Clinical Research in Australia.Also I would like to know if I can earn a good job in CR with a Diploma course or if I should take up a Masters Degree in CR?"
Question posted courtesy of:
egyank replied:
"sorry i don`t know you may search the google for better chance and put it in quetation mark to limit the search results"
swamy
asked:
"I have completed my ug in biotechnology and would like to know about clinical research.I would like to know about the opportunities in this course too."
Question posted courtesy of:
praveen replied:
"Here are some coleges which offer clinical research1. Dr. MGR Deemed University, Chennai.2. Institute of Clinical Research (India) - ICRI, Hyderadab3. Nexus Clinical Research Institute, Mumbai"
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