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KRC DEMO SESSION
Click HERE for more information about KRC's Clinical Research Professional Course.
Click HERE for more information about a career as a CDM.
Session Introduction
This sample session here is one example of the 50 learning modules in KRC's On-Line CDM clinical research professional development course. The course is designed to be used as an On-Line textbook. As such it has many excellent features, which makes this course a superb and beneficial learning tool. For example, throughout the course you will have instant access to our On-Line Glossary/ Definitions and Abbreviations and Acronyms. Through these links, you will have immediate access to a wealth of knowledge and critical terms, to help you with your studies. Additionally, throughout the body of the text, you will encounter highlighted terms like this: "FDA form 1572". By clicking on these terms, you will get an instant definition and explanation of this term.
You complete the sessions at your own pace and submit your answers to the open questions directly to live, on-line teachers (active researchers in our company involved in real clinical trial projects). Most of our teaching personnel have MSc - PhD level experience in clinical trials-related areas and have extensive clinical research experience. Each and every answer to open questions that you submit receives comments from our on-line teachers. They will send you additional related articles, you will submit your feedback on the articles and receive comments if needed. You will also receive comments on every practical task you submit. This usually amounts to at least 200-250 communications throughout the program. Also students ask many questions and they always get a reply. We review everything that comes to us on-line: answers to training questions, questions about practical tasks, resumes and we even give advice to help you with your future interviews.
We hope you enjoy this Demo Session...
Introduction to Drug Approval Process
in the USA and Canada
The U.S. and Canadian systems of new drug approvals are perhaps the most rigorous in the world. According to a controversial study in 2003 conducted by the Tufts Center for the Study of Drug Development, it is estimated the average cost to develop a drug is close to $900 million! Only 10 years earlier, a report by the Congressional Office of Technology Assessment indicated that it cost a company $359 million on average to get one new medicine from the laboratory to the pharmacist's shelf. It still takes 12 years on average for an experimental drug to travel from lab to medicine chest. Only five in 5,000 compounds that enter pre-clinical testing make it to human testing. One of these five tested in people is approved.
New medicines are developed as follows:
Synthesis and Extraction The process of identifying new molecules with the potential to produce a desired change in a biological system (e.g., to inhibit or stimulate an important enzyme, to alter a metabolic pathway, or to change cellular structure). The process may require: 1) research on the fundamental mechanisms of disease or biological processes; 2) research on the action of known therapeutic agents; or 3) random selection and broad biological screening. New molecules can be produced through artificial synthesis or extracted from natural sources (plant, mineral, or animal). The number of compounds that can be produced based on the same general chemical structure runs into the hundreds of millions.
Biological Screening and Pharmacological Testing Studies
to explore the pharmacological activity and therapeutic potential of
compounds. These tests involve the use of animals, isolated cell
cultures and tissues, enzymes and cloned receptor sites as well as
computer models. If the results of the tests suggest potential
beneficial activity, related compounds, each a unique structural
modification of the original compound are tested to see which version of
the molecule produces the highest level of pharmacological activity and
demonstrates the most therapeutic promise, with the smallest number of
potentially harmful biological properties.
Pharmaceutical Dosage Formulation and Stability Testing
The process of turning an active compound into a form and strength
suitable for human use. A pharmaceutical product can take any one of a
number of dosage forms (e.g., liquid, tablets, capsules, ointments,
sprays, patches) and dosage strengths (e.g., 50. 100, 250, 500 mg.) The
final formulation will include substances other than the active
ingredient, called excipients.
Excipients
are added to improve the taste of an oral product, to allow the active
ingredient to be compounded into stable tablets, to delay the drug's
absorption into the body, or to prevent bacterial growth in liquid or
cream preparations. The impact of each on the human body must be tested.
Toxicology and Safety Testing Tests to determine the
potential risk a compound poses to man and the environment. These
studies involve the use of animals, tissue cultures, and other test
systems to examine the relationship between factors such as dose level,
frequency of administration, and duration of exposure to both the short-
and long-term survival of living organisms. Tests provide information on
the dose-response pattern of the compound and its toxic effects. Most
toxicology and safety testing is conducted on new molecular entities
prior to their human introduction, but companies can choose to delay
long-term toxicity testing until after the therapeutic potential of the
product is established.
Regulatory Review: Investigational New Drug (IND)
Application An application filed with
the U.S. Food and Drug Administration (FDA) prior to human testing. The
IND application is a compilation of all known information about the
compound. It also includes a description of the clinical research plan
for the product and the specific protocol for phase I study. Unless the
FDA says no, the IND is automatically approved after 30 days and
clinical tests can begin. In Canada, a Clinical Trial Application (CTA)
is filed with the Therapeutic Products Directorate, Health Canada.
Phase I Clinical Evaluation The first testing of a new
compound in human subjects, for the purpose of establishing the
tolerance of healthy human subjects at different doses, defining its
pharmacological effects at anticipated therapeutic levels, and studying
its
absorption,
distribution, metabolism, and
excretion
patterns in humans.
Phase II Clinical Evaluation Controlled clinical trials of
a compound's potential usefulness and short-term risks. A relatively
small number of patients, usually no more than several hundred subjects,
are enrolled in phase II studies.
Phase III Clinical Evaluation Controlled and uncontrolled
clinical trials of a drug's safety and effectiveness in hospital and
outpatient settings. Phase III studies gather precise information on the
drug's effectiveness for specific indications, determine whether the
drug produces a broader range of adverse effects than those exhibited in
the small study populations of phase I and II studies, and identify the
best way of administering and using the drug for the purpose intended.
If the drug is approved, this information forms the basis for deciding
the content of the product label. Phase III studies can involve several
hundred to several thousand subjects.
Process Development for Manufacturing and Quality Control
Engineering and manufacturing design activities to establish a company's
capacity to produce a product in large volume and development of
procedures to ensure chemical stability, batch-to-batch uniformity, and
overall product quality.
Bioavailability Studies The use of healthy volunteers to
document the rate of absorption and excretion from the body of a
compound's active ingredients. Companies conduct
bioavailability
studies both at the beginning of human testing and just prior to
marketing to show that the formulation used to demonstrate safety and
efficacy in clinical trials is equivalent to the product that will be
distributed for sale. Companies also conduct
bioavailability
studies on marketed products whenever they change the method used to
administer the drug (e.g., from injection or oral dose form), the
composition of the drug, the concentration of the active ingredient, or
the manufacturing process used to produce the drug.
Regulatory Review: New Drug Application (NDA) An
application to the FDA for approval to market a new drug. All
information about the drug gathered during the drug discovery and
development process is assembled in the NDA. During the review period,
the FDA may ask the company for additional information about the product
or seek clarification of the data contained in the application. In
Canada, the parallel process is the New Drug Submission (NDS).
Post approval Research Experimental studies and
surveillance activities undertaken after a drug is approved for
marketing. Clinical trials conducted after a drug is marketed (referred
to as phase IV studies in the United States) are an important source of
information on as yet undetected adverse outcomes, especially in
populations that may not have been involved the pre-marketing trials
(e.g., children, the elderly, pregnant women) and the drug's long-term
morbidity and mortality profile. Regulatory authorities can require
companies to conduct Phase IV studies as a condition of market approval.
Companies often conduct post-marketing studies in the absence of a
regulatory mandate.
Drug Prices Almost everybody has bought medications in the pharmacy. You certainly have paid attention to the high prices that all of us have to pay in order to by new drugs. Sometimes you buy 10 tablets for $ 50, sometimes you pay even more.
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Why do these tiny pills cost so much? Please, share your opinion:
(Please don't abuse answering this question. You can be asked one on your future job interview. We are reviewing all of your answers and we will contact you in order to correct any serious mistakes.)
You may be right, that the drug market is demand / supply regulated as any other market is. But there is another factor that you have probably mentioned in your statement above: the new drug development and approval process is an extremely costly and risky venture. It could cost tens and even hundreds of millions of dollars and yet yield absolutely nothing in the end. In the frames of development of one new medication, a pharmaceutical company screens up to 10,000 compounds, only 200-300 of them enter pre-clinical testing, and only 5-6 start clinical testing. In the end you can have only one making it to the market, and even this would happen only if you are lucky enough. This is not all. Now, you have to succeed in marketing your new drug, and that's not easy with all the competition in the market. Clinical Research is an important part of the process that every new therapeutic product should pass in order to receive approval to be placed on the pharmaceutical market. No clinical trial can be done without you, if you choose to become a CDM (Clinical Data Manager) Now you can see why a pharmaceutical company or contract research organization would be desperate to hire you and pay you very substantial wages in order to ensure that this research runs smoothly with no delays. (every day of delay can cost up to 1 million dollars in losses). It is important to be efficient and cost-effective when developing a new drug!
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What would you do, if one day you get an idea for a new therapeutic compound with the wonderful ability to treat all human diseases. How would you get it to the market?
Please, share your opinion:
(Please don't abuse answering this question. You can be asked one on your future job interview. We are reviewing all of your answers and we will contact you in order to correct any serious mistakes.)
Please, enter your name, e-mail and telephone to let our on-line instructors contact you.