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 some clinical research recruiters, CRO-s
and pharmaceutical companies that recognize us as a reputable
institution. Some of them are posting their openings for clinical
research positions on our site .
Our Diplomas state that the student has passed a program on ICH GCP
which is a standard requirement in this industry.
Who can become a clinical investigator?
First of all, clinical investigator must be a physician with a license
for medical practice in the country where he or she wishes to act as a
clinical investigator. One of the reasons that most people become physicians is that they love to learn. Probably one of the most exciting times in the life of a physician is during medical school when he or she is continually gaining new knowledge and being exposed to new technology. But even in medical school, when you devote 100% of your time to learning, it is impossible to keep up with the remarkable expansion in medical science. However, since few of us have the luxury of remaining a student our entire career, most of us become increasingly obsolete from the very day we leave our training
programs.
If you want to remain close to medical science and to the development of new drugs and devices that correspond to the way you practice, then clinical research may be both emotionally and intellectually satisfying. At times, you can have the exciting experience of being involved in truly innovative products that are breakthroughs in treating specific diseases. When this happens, you feel that you have contributed to medicine and to the general welfare in a way that is difficult to replicate.
. By participating in a trial you will learn basic pathology and pharmacology as you explore the mechanism of action of that specific drug. Also, you will come into contact with experts in the field who will instruct you in their methodology in treatment, and you will probably utilize, as part of the study, the most modern and specific method of measurement to assess both efficacy and toxicity. All these things are applicable and will improve your current techniques in treating your other, non-study patients.
Another benefit to becoming involved in clinical research is becoming an author of the trial report. Frequently, investigators who have successfully enrolled a large number of qualified patients are asked to help write the trial results in a scholarly medical journal. This, of course, leads to many speaking opportunities, some of which are a natural result of the publication and others of which are because of promotion by the pharmaceutical company. Public speaking, by the way, can also result in some healthy stipends and a nice supplement to your income in and of itself. However, the chief joy comes from the fact that your colleagues perceive you to have some specific expertise. It is very gratifying to be able to introduce
something in the way of new information to your comrades-in-arms.
Your accreditation board may accept publishing in journals and attending start-up or post-trial meetings as continuing medical education credits. The same is true of those lectures you deliver.
Who
can train Clinical
Research Investigators ?
How valid is this certification?
At
present, there is no professional designation for the positions
of Clinical Research Investigator. There is no need for any
certification, though training in Good Clinical Practice is essential
in order to comply with FDA / TPD regulations and essential to become
the clinical investigator.
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: "Clinical
Investigator (CI)" is a titles not credential. It neither imply nor
require "certification".
However,
many companies use Certificates of Training as a screening mechanism
for selecting the right clinical investigator. 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.
How
your Clinical Investigator Career will affect your patients?
As a physician who conducts clinical research, you will be providing your patients with additional treatment options. This can be vitally important for people with life-threatening or chronic diseases. It also can be of major importance to those individuals who simply have not found appropriate medical solutions to more mundane illnesses. For example, patients often cannot tolerate the current best therapy because of idiosyncratic reactions, side effects or allergies. The ability to offer all these individuals something new and potentially effective is a significant accomplishment. So, in a very real sense, a physician engaged in clinical research is providing his or her patient with the opportunity for improved medical care. Your patients will view you as a physician who is on the cutting edge of medicine.
There is another reason that becoming involved in clinical research can be
good for your patients. Many people today have inadequate health insurance or none at all. For some people, the only way they can afford medical treatment for their chronic conditions and ailments is to enroll in clinical trials. Volunteers in clinical trials are not charged for either the medication or treatment, if it specifically involves the indications relevant to the trial. But it is also not unusual for patients' other illnesses or minor complaints to be treated at no charge if they are participating in a trial. In fact, it is a good business practice to reward those patients who participate in this manner because they are actually allowing you to make more in the way of income from their participation than you would normally earn from conventionally treating them.
Different
aspects of your involvement in clinical trials
It is important that you, as an individual who is considering involvement with clinical trials, understand both the positive and negative ramifications of your involvement. In a study done for the NIH in 1997, R. Mechanic dubbed a potential negative issue as "the zone of uncertainty." In the way of background, patients participating in clinical research are guaranteed treatment of any side effects or complications that occur as a result of their direct participation in that trial. This is a necessary element of the consent form. "The zone of uncertainty" occasionally occurs when there is an attempt to determine whether a particular complication is a result of the trial or a natural course of that patient's pathologic process. For example, if a patient is entered into an angina trial and suffers an exacerbation that requires his or her hospitalization {while beginning to be treated with an experimental drug as opposed to standard therapy), then who is responsible for the cost of that hospitalization: the pharmaceutical company or the patient's insurance company? It is possible for the patient to be caught in the middle here, and he or she might have to involve an attorney to rectify this situation. Again this is a rare occurrence.
"The zone of uncertainty" issue evolved as a result of managed care. Prior
to the current age, insurance companies seldom knew if their patients were involved in clinical trials. Today it is likely a patient being treated outside of the normal paradigm and referral patterns sanctioned by the HMO will be quickly discovered.
Clinical trials can be good for your patients, if
you keep in mind some important axioms. The first axiom for all clinical investigators must be to do no harm. It is most important that, in your medical opinion, there are no significant dangers to which you would expose your patients unnecessarily. And this, of course, includes any risk involved in stopping that patient's cur- rent therapy. Clearly, though, everything is relative. In a life-threatening
illness, more risk might still be well within the realm of acceptability.
A second axiom is that a patient should never in any way be coerced into a clinical trial. A clinical trial must be presented in a fair and balanced way and the decision to enter must be left to the patient, who needs to be free from both overt and covert influences. As that patient's physician, you must refrain from allowing your own desires to inadvertently influence the patient. Remember that you are an authority figure, and that frequently, patients will act out of a desire to please you rather than in a way that they perceive as in their own best interests.
A third important axiom is that the patient must have a complete under-standing of the risks, benefits and requirements of a clinical trial. It is important that the consent form {which delineates safety, visit requirements, etc.) be reviewed in detail by the investigator at a level that is compatible with that patient's language skills and intellect. It is also worth presenting this information to other members of the patient's family, so that everyone has a clear understanding of the situation. In fact, it has always been my practice to have a patient's family member witness his or her signature on the consent form.
You and your patients may be concerned about patient safety issues. What are the risks associated with volunteering for a clinical study? There can be risks, but the research process is designed to minimize them.
Most investigators become involved in conducting phase II through phase
IV trials and rarely do phase I. There will be further discussion about all the trial phases in
this on-line course. However, prior to phase I where a drug is tested for the first time in healthy humans, all products undergo extensive animal testing. So, by the time a drug reaches phase II tests, much has been learned about the drug's toxicity, half-life and potential side effects.
The general intention of each phase of trials is to further expand safety and dosing knowledge. Therefore, an investigator involving himself or herself in phase
IIl trials can be assured of much more information regarding these parameters. And, phase
II trials are the earliest phase of trials in which practically all clinical investigators will become involved.
As an investigator, you will receive a protocol and a drug manual. The drug manual delineates all the relevant knowledge that has been accumulated about the drug being tested. It includes animal data as well as information on phase I testing and any previous phase
I and phase II - III trials done any- where in the world. A copy of this manual, along with the protocol, must be forwarded to your IRB
(we will give a definition of IRB / ethic committee later in this
course) prior to approval of the trial. It is vital that you, as an investigator, read this manual carefully so you can become familiar with any potential problems or side effects discovered earlier in the drug development process. Not only does this information impinge upon your decision to take the trial, but it makes you aware of what problems to look for as the trial progresses. Please remember that you must be comfortable with the risks and benefits to your patients in the trial. If you are worried
about undue hazards or side effects that seem too severe to justify, then you should not take this trial. It is impossible for an investigator to function effectively under these types of circumstances. So, always remember that you are the final judge of what is appropriate and what is not.
Most clinical trials you become involved with will not be on "first in the class" products, but on "me too" drugs. While this creates less interest for the investigator, it adds a great margin of comfort because a similar product has already been marketed, and the side effect and safety profile will probably be rather similar.
It can be argued that patients in clinical trials are actually safer than patients not in clinical trials who are taking the same or similar products. This is because patients in clinical trials are much better monitored than those who are not. Trials require many more visits to the physician than what is typical in routine practice and also, in general, much more frequent testing than would normally be done. Also, the clinical tests and parameters utilized are frequently at the highest level of technology
available.
Frequently, because of the thoroughness of the examinations required by clinical trials, serious and silent coexisting disorders are uncovered. During my experience conducting clinical trials, I have uncovered three malignancies only because of the extensive testing required by the
protocol. In two of the cases, the patient's life was saved.
When considering involvement in clinical trials, it is important to step back for a moment and to consider participation from a different perspective. It has been stated that the administration of one million doses of a medication is required before an adequate side effect profile is developed. In most instances, a medication is released on the market after administration of several thousand doses or less. It is clear from the frequent withdrawal of marketed medications that many people are in danger of suffering
potentially serious side effects from many medications that are assumed to be safe because they have received FDA
/ TPD approval. It is important to remember that every time someone takes a medication, whether it be approved, over the counter, herbal or as part of an experimental protocol, there are potential dangers.
How involvement in clinical research will affect your practice?
Most of us have worked very hard to build and grow a practice, so concern about the effect that clinical research might have on an ongoing practice is appropriate. No one should do anything to jeopardize something of such great value without prolonged and careful consideration.
When considering venturing into the clinical research world, your patients' perceptions are an important issue but your associates', partners' and staff's receptivity are also important. It is clear that when you intro- duce an endeavor with such enormous potential into a stable organization, there is a strong possibility of disrupting functions. You must explore all potential changes in advance. These include changes in work scheduling, coverage, measurements of productivity and income.
If you don't plan out an appropriate structure up front, then it is likely that this pursuit will end in disaster. Many practices have been torn apart when one partner becomes increasingly involved in research to the detriment of his or her regular and customary duties. Also, when these activities result in additional cash, there are frequently problems because little thought was given, up front, to alignment of rewards and labor. New relationships, mechanisms and paradigms must be worked out between the partners in a practice. Extra cash is always helpful to a medical practice, but dividing the money is frequently contentious, particularly when one party feels that he
or she has been predominately responsible for the windfall.
In the past, those physicians who chose to indulge in the pursuit of clinical research frequently found that their colleagues did not understand what they were doing. The other physicians in the area assumed that this was a scheme to move their patients to the researcher's own practice, and the fact that the subjects were not charged heightened their suspicions. The further removed a physician was from academic centers, the more of a factor this was. Today this response seems less likely as more of the medical community is aware of clinical trials but still, you must be prepared for a negative reaction particularly if you are the first in the region to get your feet wet.
Interestingly enough, most physicians who have gotten involved in clinical research will attest to the fact that clinical research has actually helped to build their practice. Physicians in clinical research often find that their reputations are enhanced in their local communities. They are perceived as being on the "cutting edge" of medical knowledge and as having access to the most innovative and modern therapies. Frequently, practice doctors who do research find that they achieve a high profile through positive stories in the press and through recruitment efforts either sponsored by the physician or by the sponsoring company. For example, one recruitment strategy for an influenza vaccine trial might be to give lectures at senior citizen activity centers. Clearly, you would gain a reputation as an expert on this disease in your community and probably, as a result of your education in conjunction with the trial, this perception would be correct.
As a principal investigator, some time and travel will be required. First, you must educate yourself about the process and the responsibilities of doing trials. You must understand and supervise each trial, interact with the IRB, develop budgets, deal with audits and inspections, and perform other duties. If structured appropriately, this should not be an over- whelming amount of your time but it does require attention. Doing clinical trials is not a hands-off activity. Of course, the income produced from these activities will far exceed what you can do through routine practice. However, as a group, your practice must deal with fair divisions of money and labor. The principal investigator will need to be covered when he or she attends start-up meetings, resulting in an increased workload for the others. Your partners will need to be compensated for their extra work.
You will change all the dynamics and interpersonal relationships in your office when you introduce specific personnel such as study coordinators. The current staff might perceive these changes as increasing their workloads without increasing their compensation. For example, your receptionist might consider that his or her new requirement to get a separate appointment book for each study coordinator and the need to schedule monitoring visits from the company are simply extra burdens. On the other hand, if this additional work is accompanied by additional perks or the opportunity to earn additional income, he or she might be the coordinators' best advocate.
Your nursing staff might perceive your coordinator as a new elitist addition to the office and their status might be threatened by the introduction of a better-trained and paid individual. They may find themselves relegated to a lower rung in the new hierarchy. However, this can be mitigated if the coordinator has an appropriate attitude and also, perhaps, lends" a hand to the office staff during peak times.
5pecific ways to deal with these issues will be discussed in later chapters.
Any physician considering becoming involved in clinical research needs to weigh all the pros and cons. Clinical research can clearly help a physician rediscover the intellectual joys of medicine. You will feel the rewards of becoming part of a community of researchers. You will, on occasion, have the opportunity to contribute to the advancement of medical therapeutics. There are also definite financial advantages because clinical research has the potential to develop revenues that are hard to duplicate through any other medical endeavor.
A commonly asked question is whether clinical research will increase your malpractice exposure or increase malpractice insurance premiums.It would be wise for all those considering involvement to contact their insurance carrier. It is, in fact,
involvement in clinical research decreases exposure, but this is dependent upon the investigator being diligent in adherence to the protocol. If you stray from the sanctioned pathway, you might find yourself on your own. For example, if you ignore inclusion and exclusion criteria or admit a subject who clearly is a protocol violation and that subject has a mishap because of this, you might very well find yourself out on a limb.
Whenever a patient enters a clinical trial, he or she must sign the consent form. As long as consent is obtained properly and the form is designed to meet good clinical practice ( GCP) standards, it provides a good deal of legal protection to both the researcher and the pharmaceutical company.
A different issue, but one that needs to be discussed, is fraud. On a rare occasion, and primarily for financial reasons, an investigator or someone employed by an investigator acts in bad faith and makes up data or even entire patients. This, of course, can result not only in financial ramifications but also in criminal charges. Those who do it and are caught wind up on the FDA's blacklist and are restricted from future participation in clinical trials. This type of behavior always amazes me because clinical research is so lucrative when done in the right way.
Why do we ask open
questions?
Because we wish to prepare
our students for an interviews with prospective CRO /
sponsor. Most
of our open-ended questions are based on questions asked by sponsor during interviews with our previous
graduates - clinical research investigators.
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 sponsor you need to be competent in professional and
GCP terminology and related concepts. So, you are encouraged to use this
opportunity to prepare yourself for a real interview by answering
our open questions as best as you can.
We are here to help you. If there is anything that you don't
understand just ask. There is nothing that cannot be explained.
You will have access to a bonus course in pharmacology and medical
terminology on-line, and a medical slide show. Why not to take
advantage of it too?
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 act as a Clinical
Research Investigator. You have complete coverage of all materials needed, interactive
practical questions. Upon completion of this
program you will pass on-line final exams and receive by mail
Diploma stating your new qualifications .
2. You receive very special
designed Diploma stating as program objective "IGH GCP Guidelines
for Clinical Research Investigators ". This is essential in order
to get a grant for clinical research project as clinical research
investigator.
3. You get perpetual support
of our research centre staff when you mention our institution in your
resume as a place where your potential grantors could obtain
references. Almost always, prospective grantors would make a call to
collect references in a personal phone conversation.
4. You get active help in
your resume editing. Remember, your resume is the first step to get a
grant. Now you would include in your resume, your knowledge of ICH GCP
Guidelines.
5. You will get a return on
your symbolic investment in your education and training at KRC at
least 40 times more than you have paid and this in very first year of
your work as Clinical Research Investigator.
6. You can apply for a
tuition subsidy for this course that could cover over 50 % of your
tuition fee.
7. Of course, our research
center would prefer to select clinical research investigators that we
have trained as investigators for our research projects and / or refer
them to our partners in the industry.
Please, enter your
name, e-mail and telephone to let our on-line instructors
contact you.
