Kriger
Research Center Inc. is an organization with broad expertise in
the planning, execution and interpretation of research projects.
As our clients know, KRC Inc. serves as a partner in clinical research
with extensive experience in different phases of clinical trials.
KRC Inc. provides focused, comprehensive planning, which leads to a
successful trial. Beyond the trial, we remain involved and committed
to a development process that is custom-designed to our clients'
needs. We are committed to investing in ongoing training for our
employees to ensure they are kept on the leading edge of new
technologies. These training initiatives include interactions with
academia, attendance at scientific conferences and meetings, training
courses from experts in various fields, etc.
We have
good working relationships with most reputable clinical research
recruiters such as Kelly Scientific Resources,
clinical research organizations (CRO),
and pharmaceutical companies that recognize us as a reputable
institution. Some of them are posting their openings for clinical
research positions on our site . We have also an affiliated
recruitment agency Biorole Scientific Solutions Inc. All our graduates
are eligible to post their resumes on it's web. based database www.biorole.com
. The
famous recruiter for biopharmaceutical industry Woolf Group is
routinely recommending KRC Inc. training in their e-mails to
unqualified candidates.
Our Diplomas state that the student has passed a program on ICH
Good Clinical practice (GCP)
which is a standard requirement in this industry.
The most important benefit of our program is student enrollment
in a volunteer position in real projects that give
essential initial experience in the field. This is what potential
employers like about us because our graduates know exactly what they
are going to do in the industry, and that's what every employer
actually needs.
Most of KRC Inc.
graduates become members of the Association of Clinical Research
Professionals, an industry-recognized organization.
The
KRC Inc. Programs are recognized by the
Society
for Clinical Data Management
and
KRC is currently in negotiations to become a certification-training
provider for this organization. KRC
invited to send a speaker for the Society’s
Fall Conference. A request was also made at that time for KRC to
provide certification training for the Society for Clinical Data
Management’s Certification Exams.
KRC is listed on the most respected and trusted website for the
Clinical Trials Industry: http://www.centerwatch.com/professional/prv392.html
as a CRO and as a Training
Institution .
KRC
Inc. graduates have been hired by many other industry providers. (AAI
Development Services Clinical Trials Division, Woolf Group , Princess
Margaret Hospital,
University
Health Network )
. Over
half of KRC’s current or previous employees are KRC Inc. graduates.
All
graduates are involved as volunteers in research activities, are
evaluated by KRC Inc. Practical Projects Coordinators and are entitled
to receive references for their participation. Other industry
providers recognize and accept these references.
Why
would you need this program?
This truly interactive program
can help you gain appropriate knowledge and practical skills in
order to apply for the position of Clinical Research
Associate/Coordinator . Upon completion of this program and
after passing on-line final exams you will receive, by mail, a diploma
stating your new qualifications. You will be approved as a
clinical research associate to participate in clinical
research projects at our center. You will be appointed to one of the
on-line research groups working on a specific drug. You will receive
individual clinical research tasks that will give you sufficient
experience to get started on your first job in this field. Modern
clinical research activities are almost entirely based on networking
and internet on-line communications. Your experience in this area will
be most valuable for your future employment. All your tasks you will
be received on-line and will be conducted by you as a home-based
Clinical Research Associate.
You would actively participate in the development
of some parts of the protocol, preparing CRF-s (Case Report Forms),
reviewing informed consent forms, networking with potential
investigators, initiating clinical research sites, monitoring,
creating databases, performing data entry and analysis and many other
tasks. You will utilize your knowledge of ICH GCP (Good Clinical
Practice) in each phase of the clinical research. You will submit your
work for approval by e-mail. At the end of your work you will receive
a reference letter stating your new qualifications and experience with
our contract research center. At this stage you could work with our
company as a volunteer. The most successful participants could be
offered employment with our company upon completion of this program.
There are 50 sessions with many open ended
questions in this program. You move through sessions at your own pace
and submit your answers to the open questions to life on-line teachers
(active researchers of our company involved in real clinical trials
projects). Most of our teaching personnel has a MSc - PhD level
in clinical trials-related areas and have intensive 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. That usually adds up 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 with
your future interviews. We also prepare reference letters for
successful participants in research projects. The assessment of your
performance works like this: We save all your answers and your
comments regarding the additional articles in special folders under
your name. When you finish the course and pass your on-line final exam
we receive notification from the final page of the course along with
your request to issue a Diploma. We then check your participation in
answering the open questions. If you have answered enough of them -
you get your diploma by mail. If not, we ask you to answer some more
questions, and after you have completed them, you get your Diploma by
mail. It is recommended to
save a copy of all your answers in one or two text files in order to
be able to re-submit them if necessary. Our responsibility is to make
sure that a Diploma is issued only to those who qualify, in other
words, have demonstrated his/her knowledge by answering most of our
questions.
Why
are there not enough Clinical Research Associates (CRA) on
the market and why is it important to train the new specialists out of
other professions with the right educational background?
In
fact, the market is currently expanding faster than the production of
new qualified professionals which inevitably creates a demand.
Most people are under the impression that the barriers to enter
this industry are extremely difficult to overcome, but the truth is
that everybody working in this industry had to start somewhere and as
the industry grows positions need to be filled.
Now the question is: how will this be accomplished?
One way of filling the vacuum is to take specialists from other
professions and turn them into professionals for this industry.
This has several added benefits of its own.
For instance bringing specialists from other professions or
industries actually diversifies the workforce and brings new
perspectives to the biopharmaceutical industry.
This in turn is a source of innovation where multiple
disciplines are being united and new perspectives are made more
apparent.
Of course, the need for training is obvious for specialists
that are re-aligning their careers as well as for individuals
that are entering the industry as new graduates.
Most of the skills and knowledge required in positions such as
CRAs, Clinical Data Managers (CDMs), Quality Assurance (QAs) and Marketing Managers are not covered in
university courses. Even
where an individual has been through a specially designed training
program for the position through an academic institution, the training
may not involve a practical component in which case the individual
still lacks certain skills.
This should re-emphasize the importance of practical training
programs for the biopharmaceutical industry.
The
educational system does not appear to produce enough graduates to meet
the demand for entry level positions like CRA, Data Manager
Specialists, Quality Assurance Specialists and Marketing and
Management specialists. Skill shortages also affect the ability
of regulatory agencies to keep abreast of scientific advances and to
efficiently review the increasing number of new products. The diverse
range of skills required along with the dramatic pace of change is not
reflected in current university courses. The shortage of specialists
could be felt in other areas as well. For example, bioinformatics
requires a background in genetics, statistics, and software
development, but most graduates lack such multi-disciplinary training.
Also, there are no Canadian undergraduate degree programs in
bioengineering; specialization options are normally offered within
more traditional programs.
Who
can train Clinical
Research Associates?
How valid is this certification?
The ideal training environment would be in a research company itself
(like ours) where the trainees can gain access to real practical
experience. Most if not
all companies are very reluctant to hire individuals without any
experience, so even 6 months as a volunteer (you get 6 months
equivalent experience participating in our 4 research projects) could
be enough to get
oneself into an entry level position.
Certification
is a process by which a non-governmental agency validates, based upon
predetermined standards, an individual's qualifications and knowledge
in a defined functional or clinical area. The issue of being
"certified" is confusing for many people who begin looking
at Clinical Research as a career, for example: "CRA" and
“CRC” are job titles not credentials. They neither imply nor
require "certification". The job function of CRA is
not one that requires any special certification in order to perform it
unlike, say, a CPA (Certified Public Accountant) or CMT (Certified
Massage Therapist). Those are regulated job functions where people
cannot call themselves "CPA" or "CMT" unless they
have gone through specific procedures regulated by a governing body.
However,
many companies use certificates of training as a screening mechanism
for hiring or promoting employees. This results in multiple sources of
training for clinical research professionals, where the certifications
are tied to the completion of different courses offered by various
training providers.
A
certification offered by a pharmaceutical research company would be
recognized in the industry as a professional development course.
More important than this however, is the reference that backs
the certification. An
individual with a reference from a pharmaceutical company will be held
in a higher regard than an individual with a reference from an
academic college. In this
industry especially, reputation is very important and goes a long way
– professional references are usually the deal maker or breaker when
a person is considered for a position.
CRA Job
Description
A Clinical Research Associate
is a professional who monitors the administration and progress of a
clinical trial (pharmaceuticals, biologics, or devices) on behalf of a
sponsor. A clinical trial is a scientific study of the effects, risks
and benefits of a medicinal product, including new drug substances and
currently marketed drugs. A CRA might also be called a clinical
research (or trials) monitor, executive, scientist or coordinator,
depending on the company.
Typical Work
Activities
Typical work activities
include :
|
locating
and briefing suitable doctors/consultants (or
investigators) to conduct the trial; |
|
setting
up the study centers - ensuring each center has the trial
materials and checking that the investigator knows exactly
what has to be done; |
|
monitoring
the trial throughout its duration which will involve
visiting the study centers on a regular basis to check the
patient data in the case report forms (CRFs) and to sort out any problems
which may arise; |
|
validating
and collecting completed CRFs from hospitals and general
practices; |
|
closing
down study centers on completion of the trial; |
|
discussing
results with the statistician. Writing technical reports
on the trial is usually carried out by a medical
statistician. |
The job of a CRA can vary
tremendously from company to company. In some companies, you would be
involved in the whole process - from sitting down with the doctor who
has the idea for a trial, and actually working out a protocol, to
writing up reports after the analysis has been done. In other
companies it would be the medical adviser who initiated the trial and
you could just be involved in collecting data once the trial has been
set up.
One CRA summed up the work by
saying: 'I enjoy the project related aspect of CRA work - there's a
good mixture of short-term tasks which are quickly achieved and offer
a lot of small challenges, and longer term objectives and aims.'
Work
Conditions
|
Typical
starting salaries range from $ 40,000 to $ 60,000 |
|
Typical
salaries with 3 and more years of experience range from
$60,000 to $ 90,000 |
|
Salaries
vary quite widely from company to company. A car is
generally provided and bonuses may be paid. |
|
Working
conditions vary between companies. You will need to work
extra hours regularly, although weekend or shift work is
uncommon. Generally a limited amount of time is spent in
the office. The work is mainly on the road visiting trial
centers, general practitioners (GPs) or hospitals; dealing with doctors and
research nurses. The work requires a fairly smart dress
code. In some companies, CRA's operate from home, only
visiting the office for briefing meetings, training, etc.
For the majority of the time the CRA's will work alone.
Self employment or freelance work is sometimes possible
and some contract houses employ CRA's on a freelance
basis. Part-time work may be possible but is more likely
in a contract house. There are 70-80% women in the
profession and career breaks are possible. |
|
Jobs are
found in restricted locations. Some work is localized
(company laboratory) and some are regionally based. |
Time deadlines can make the
work stressful. Travel within a working day and absence from home at
night are both frequently needed, which may disrupt home life. Some
companies operate a system whereby the CRA specializes in a specific
disease area and therefore covers the whole of country - others
operate their CRAs on a regional basis. If you are working for an
international company, you could be coordinating trials outside the
country, so a considerable amount of overseas travel would be
necessary.
Entry
Requirements
The relevant degree subject
area is life and medical science. In particular, the following
subjects may increase your chances:
|
biochemistry; |
|
anatomy; |
|
biology; |
|
biomedical
science; |
|
dentistry; |
|
microbiology; |
|
medicine; |
|
nursing; |
|
molecular
biology; |
|
physiology; |
|
pharmacology; |
|
pharmacy. |
A life science degree
(especially pharmacology, pharmacy, biochemistry, immunology,
physiology or toxicology) or nursing degree is one of the requirements
for entry into CRA work. Other science degrees may be accepted. It is,
however, relatively unusual for a graduate with no relevant prior
experience to go straight into CRA work, although some companies will
employ recent graduates with the necessary personal skills. As a
graduate with no previous relevant experience you would be more likely
to enter the field at a lower level, e.g. as a clinical data
coordinator. These are generally jobs, which deal with the data
handling/co-ordination part of the CRA's job without the involvement
of initiating and designing the trials. Experience in this type of
work would generally qualify you to move on to a CRA position.
Entry without a degree or
without a certificate is unlikely, although it is occasionally
possible to enter from the administration side. A relevant PhD is
advantageous in some companies, both for entry and to gain promotion
to senior positions or to move into protocol development.
In addition to a scientific
or nursing background, companies will look for excellent communication
skills (both written and verbal), an ability to get on with people and
an eye for detail. Numeracy, commercial awareness, good organizational
and administrative skills are also important. The job requires a lot
of self-motivation and the ability to assimilate information quickly.
A mature attitude is essential and mature students with relevant past
experience may have an advantage. The people aspects of this job mean
you will need to show an outgoing, confident and friendly personality.
A driving license is needed and you must be able to understand the
importance of Good Clinical Practices (GCP). Having relevant pre-entry
experience is desirable and could include: a medical practice, a
nursing background, medical sales, clinical laboratory work, clinical
data work and pharmaceutical research.
Because of the
ever-tightening government regulations on the licensing of new drugs
and re-licensing of existing drugs, the need for CRA's is increasing.
Training
This is mainly in-house and
on-the-job, supported by short courses in specific topics. Some
companies offer block or day release to CRA's to pursue clinical
studies courses such as qualifications in clinical research or
clinical science
Career
Development
Career structures will
obviously vary from company to company and are not always very clear
cut. However, most companies have clinical trials management/executive
positions which would be the next step for an experienced CRA. Some
companies like PhDs for senior posts. For positions such as medical
adviser or medical director, a medical degree is usually required.
Typical
Employers
You would either be employed
directly by pharmaceutical companies or by contract research
organizations (CRO - agencies which employ clinical research staff to
contract out to pharmaceutical companies). Hospital academic
departments occasionally employ CRA's
Sources of
Vacancies
See specialist press for
recruitment agencies or contact your careers service. It may be worth
registering with specialist recruitment agencies such. Alternatively
(or in addition) try approaching pharmaceutical or CRO companies
directly.
Clinical Research
Professional Certificate
This certificate program is
designed to provide a focused course of study for individuals seeking
to position themselves for clinical research and pharmaceutical trials
industry as a clinical research associate or a clinical research
coordinator . It will also provide knowledge and skills of clinical
excellence in monitoring scientific studies toward the advancement of
knowledge and improvement of health. This course provides a
comprehensive overview of the roles/responsibilities of both the CRA
and CRC. This program was created to provide you with the key aspects,
differences, challenges, job criteria and demands, and industry
expectations of both job roles. We will provide the foundational
preparation you need to become a Clinical Research Associate (CRA) and
/or Clinical Research Coordinator (CRC). Course content will focus on
key concepts and information essential to effectively function in the
research arena. This course can open doors to new and exciting career
opportunities in clinical research as the demand for qualified and
trained CRAs and CRCs is still growing.
This course will provide the
preparation you need to enter the pharmaceutical research arena as a
Clinical Research Coordinator (CRC). Employment opportunities for
qualified CRCs continue to grow. CRCs assume overall responsibility
for assisting the investigator in conducting clinical studies of
experimental drugs and devices. Typical CRC job responsibilities
include:
- tracking the status of all study
activities
- scheduling study procedures
- developing operational plans
- managing the day-to-day activities of a
study
- serving as the primary contact with a
sponsor
Course content will focus on
key concepts and information essential to functioning in the research
arena. The program begins with an overview of the drug development
process and the regulated environment. Other topics to be covered
include skills and insights in areas related to negotiating budgets,
sponsor site visits, clinical protocols, monitoring visits, subject
retention, and general management procedures. Completion of this
course can open doors to new and exciting career opportunities in
clinical research.
This course will provide the
foundational preparation you need to become a Clinical Research
Associate (CRA). The demand for qualified CRAs has grown
rapidly over the past several years and is expected to nearly double
within the next ten years. CRAs are usually involved with extensive
travel while they monitor clinical investigations of experimental
drugs and devices. Course content will focus on key concepts and
information essential to effective functioning in the research arena.
The program begins with an overview of drug development and the
regulated environment. Other topics to be covered include critical
skills and meaningful insights in areas related to the management of
pre-study activities, study protocols/initiation/ management/term
international procedures and collateral project level activities. This
course can open doors to new and exciting career opportunities in
clinical research. We will provide you with information on how to get
in touch with potential employers. A follow-up survey of our
participants indicates that over 1/2 of the course participants are
new working in the clinical research field after completing our
program.
Upon program completion, participants will be
able to
| describe
the drug development process |
| describe
the phases of a clinical trial |
| list the
responsibilities of sponsors, investigators, and
institutional review boards |
| describe
primary roles and responsibilities of the CRA and CRC |
| list the
required contents of an informed consent form |
| identify
documents that are part of an investigator study file |
| state how
to grade and report an adverse event |
| understand
the ethical principles guiding the protection of human
subjects |
| appreciate
the types of Sponsor-Investigator site visits |
Upon completion of this course, participants
will be competent and possess the valuable skills needed in order to
conduct and manage a well organized and controlled clinical research
study.
Why do we ask open
questions?
Because we wish to prepare
our students for job interviews with prospective employers most
of our open-ended questions are based on questions asked by employers
during interviews with our previous graduates. That is why it is so important that you answer each question in
as much detail as you can. In order to make a good impression with a
prospective employer you need to be competent in professional
terminology and related concepts. So, you are encouraged to use this
opportunity to prepare yourself for a real job interview by answering
our open questions as best as you can.
Clinical trials are about
medicine whether we want it or not. Even though pharmaceutical
companies and CRO's advertise that they want BSc. biologists,
microbiologists, mathematicians,
database specialists and statisticians for data management positions,
they do expect people to have a true interest in medicine rather
than a formal medical background. We are here to help you. If there is anything that you don't
understand just ask. There is nothing that cannot be explained.
Understanding and true interest in medicine could be more important
than formal medical education in applying for data management
positions in clinical trials.
We would like to highlight once again the benefits of your
enrolment in this program:
1. You get the essential
knowledge of everything you need in order to apply for Clinical
Research Associate / Coordinator Positions. You have complete coverage of all materials
needed and interactive
practical open ended questions. Upon completion of this
program you will pass on-line final exams and receive (by mail or in
person) a Diploma stating your new qualifications.
2. You receive a specially
designed Diploma stating the program objective: Clinical
Research Associate. ICH GCP
Guidelines, Clinical Trial Monitoring and Research Site
Coordination.. These are essential requirements for any position
of Clinical Research Associate / Coordinator.
3. You participate and gain
unique experience in a real Clinical Trial Projects:
| PROJECT
I |
Efficacy
of the lowering effect of PROLIPOSTAT®
on Blood concentrations of
low-density lipoprotein cholesterol (LDL-C) in patients with
normal and elevated blood concentrations of LDL-C
|
| PROJECT
II |
Phase
II Study the Efficacy of the healing effect of recombinant human
epidermal growth factor (rhEGF) on diabetic foot ulcers
|
| PROJECT
III |
Phase
I Study the safety and Dose determination of Immuno -
Stimulatory Therapy Agent for Bladder cancer, melanoma and colon
cancer. |
| PROJECT
IV |
Survey:
Proper Use and Cost Reduction strategies for prescription and
non-prescription drugs
|
You preparing CRFs
(Case Report Forms), reviewing inform consents forms, networking with
potential investigators, clinical research site initiation,
monitoring, performing data entry and analysis, and many other tasks.
You will implement your knowledge of ICH GCP (Good Clinical Practice)
in each phase of clinical research. Your partner will create a data
base of case report forms (CRF) results using Statistical Analytical
System (SAS)
program or in simple
spread sheet program. Conduct the double data entry. Your
partner for double data entry would enter the data for the second time
and the data base would find mistakes by verifying validity of the
data entered. You will use real CRF forms with specific code: CRF-EGF. As
your partner's Data Analysis Task you will calculate healing rates per
case and in average in control group with placebo, group with 10 mg /ml, and group with 50
mg /ml treatments. You will submit your
works for approval on-line. Upon completion of your work, you will receive a
reference letter stating your new experience and qualifications with
our contract research center.
4. You get reference letters
on your project participation adjusted to your needs and reflecting
all appropriate details of your active participation in a full-scale
research project. Without proper reference letters it is completely
useless to approach any serious Clinical Research Organization or
Sponsor in order to get a job as Clinical Research Associate /
Coordinator.
5. You get perpetual support
of our research centre staff when you mention our institution in your
resume as a place where your potential employer could obtain
references. Almost always, prospective employers would make a call to
collect references in a personal phone conversation. When your
prospective employer will call us for a reference, we would reflect
all the details of your research participation and appropriate
qualifications. This could drastically increase your chances to get a
job as Clinical Research Associate / Coordinator.
6. You get active help in
your resume editing. Remember, your resume is the first step to get a
job. Now you would include in your resume, your knowledge of ICH GCP
Guidelines, Clinical Trial Monitoring and Research Site Coordination
and Canadian experience in a Full-Scale Research Project at Kriger
Research Center Inc.
7. You get on average, a letter from us
every two weeks including Clinical Research Associate /
Coordinator Positions that you can apply for, right away.
8. You will get a return on
your investment in your education and training at KRC; many times more than you have paid, and this in the first year of
your work as Clinical Research Associate / Coordinator!
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. On average, it
costs a company $359 million to get one new medicine from the
laboratory to the pharmacist's shelf, according to a February 1993
report by the Congressional Office of Technology Assessment. It takes
12 years on average for an experimental drug to travel from lab to
medicine chest. Only five in 5,000 compounds that enter preclinical
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.
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, 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.
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
premarketing 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
extremely costly and risky venture. It could cost tens and even
hundreds of millions of dollars and could yield absolutely nothing in the
end. In the frames of development of one new medication, the
pharmaceutical company screens up to 10,000 compounds, when 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 the marketing of your
new drug. And that's not easy with all this competition around.
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 could be done
without you, if you chose to become CRA
(Clinical Research Associate) , of course. 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's all about money,
money - it is all about . . .
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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.
