valuable medical knowledge and disease-specific practice guidelines, they
also can connect you with their medical science liaison (MSL). MSLs often
have a background in pharmacy and/
or research. Thus, they can provide
insights into mechanisms of disease
treatments and go beyond discussion
of the product label, which pharmaceutical reps adhere to. They also
know what therapies or diagnostic
tools are in the phases of development
and could be available for a clinical
MSLs are also the gatekeepers for
Investigator-Initiated Studies (IISs).
An IIS is a research project that is industry funded and is solely designed
and executed by the clinician. The
application process is rigorous but
awards may be easier to obtain for
non–research-based clinicians who
want to develop a disease-specific
project that needs funding. Their
grant application process can be brief,
ideas may not require prior data, and
turnaround time to funding may be
shorter. IISs often lead to exploratory
findings that may facilitate publications or lay groundwork for large-scale grants or even clinical trials. In
some instances, you may be granted
access to internal data and prescribing
patterns, which can answer interesting clinical and research questions.
How do I get started
with clinical trials?
Being a primary investigator on a
clinical trial is a big responsibility.
You are responsible to the trial spon-
sor in addition to your patients. For
young clinicians who lack experience
with clinical trials, the first thing to
do is to find a clinician in your de-
partment or another department,
who has expertise in performing an
industry-sponsored study. These in-
dividuals can be invaluable for you
in terms of guiding you through the
study feasibility process, study start-
up, and possibly being the lead or
co-investigator with you. Partnering
with someone with expertise in in-
dustry-sponsored clinical trials will
help you gain the trust of the indus-
try sponsor, which may be a require-
ment for some.
There are many additional requirements that need to be fulfilled aside
from just having an appropriate and
adequate patient population to pull
from. You will need to have a coordinator for the study who will help
you with patient care, data entry, and
study-specific issues. Clinical trials
require a significant amount of documentation and reporting that has to
be performed within a timely manner.
There is no degree prerequisite for
the coordinator, but it can simplify
things for the clinician if they have
an RN or LPN degree. Having such
a degree will facilitate dual roles of
patient care, lab draws, drug administration, medical charting, and other
patient care matters.
In addition, you will need to have
approval from either your local or
central institutional review board
(IRB). Also, you will have to review
budget and study-specific requirements for equipment and infrastructure with your department manager.
You will need to demonstrate adequate ancillary support to process,
store, and ship biological specimens.
In some instances, you will need a
dedicated pharmacist to mix or dispense study drugs.
The process is lengthy and involved, but rewarding in terms of being involved in the drug development
process. You will have opportunities
to attend meetings at which you can
network with other clinicians and
provide the sponsor feedback on how
the study is going.
How do I develop a consulting
role with industry?
It is important to check with your
What if none of this
institution, hospital, or practice if
there are any limitations to becoming
a consultant for a pharmaceutical or
device company. If it is allowed and
will not interfere with your clinical
duties, it is important to note that this
role takes time to develop. It often
comes about after years of experience
doing research, clinical, and/or basic
science, with publications to support
expertise. Working on an IIS is a good
way to work hand-in-hand with expert
industry researchers and facilitate the
consulting relationship. Being a pri-
mary investigator of clinical trials with
successful enrollment of patients and
meeting attendance will provide you
with insight into the drug development
works out for me?
Do not give up! Persistence, experience, and hard work are the keys to
developing relationships with industry.
Remember, industry has a vast network of clinicians and researchers they
already work with. The overall pool of
companies and experts is limited and
can be difficult to break into. But it can
be done. Some rely on their research
experience, clinical training, and mentors to develop the necessary contacts.
Others can develop the contacts via
IIS applications. Industry lacks access
to the physician-patient experience;
this can be your greatest asset and key
to your success if leveraged properly.
You can consider applying for men-torship with experts in your field via
AGA-sponsored events held annually at
DDW® to get additional guidance.
It is important to remember that all
industry relationships require time to
develop. They also come at an opportunity cost of time away from your clinical practice and your family, friends,
and hobbies. However, these relationships also offer a way to increase your
insight into new and old treatment
and diagnostic paradigms. It is also a
way to remain excited about your field
and prevent the feeling that your day-to-day clinical practice is becoming