Introduction
to Clinical Research
It is a well-known fact that for overall career growth; right
education, acquiring practical knowledge and developing a right attitude is of
immense importance especially in specialized industries such as clinical
research. Clinical research defines the entire profile
of a drug or any newly fabricated medical devices, tracking its development right
from its inception in the research centre to the consumer market and beyond. The recorded history of clinical trials
goes back to the biblical descriptions in 500 BC.[1] The drug
development and medical device industry has observed a remarkable evolution over
the decades. Due to a paradigm shifting change in the field of biotechnology
and pharmaceuticals, companies have gained momentum in developing highly unique
and safe medical devices and drug molecules.
What
happens in Clinical Research
The new molecule or device is
subjected to pre-clinical and clinical trials before entering the market, which
is later followed by post-marketing surveillance. Pre-clinical studies consist
of studying and analysing the effects and side-effects the drug has on animals,
that generally comprises of carcinogenicity, teratogenicity and toxicological
studies. The successful pre-clinical studies call for an Investigational drug
application (INDA) to take permission for human studies, to mark it eligible to
conduct clinical trials (four phases) in human population.[2]
Types
of Clinical Research
Based on study design, there are two main
types of clinical trials, Observational
and
Interventional study:
The U.S. Food and Drug Administration (FDA) and its corollary agencies abroad
have classified four
phases that needs to be administered during a clinical trial: [2]
Phase I trials:
- Study Participants: 20 to 100 healthy volunteers or people with the disease/condition.
- Length of Study: Several months
Phase II trials:
- Study Participants: Up to several hundred people with the disease/condition.
- Length of Study: Several months to 2 years
Phase III trials:
- Study Participants: 300 to 3,000 volunteers who have the disease or condition.
- Length of Study: 1 to 4 years
Phase IV trials:
- Study Participants: Several thousand volunteers who have the disease/condition.
Market value of Clinical research
In the
year 2017, the market size of Indian clinical trials was valued to be around
USD 1.6 billion. It is likely to develop with a growth rate of 8.7% by the year
2025. India has been ranked second (after China) in terms of patient population
for clinical trials. To add on, the low cost of clinical trials in India in
comparison to United States of America and Europe is an important aspect to
drive the market growth. [3]
Importance of Clinical Research
Clinical trials not only provide the
masses with information about an upcoming blockbuster drug
but can also shed valuable information on the benefits and safety of existing
therapies, providing reliable information for doctors and patients to choose
between alternative therapies.
Finally, since "to ensure their
safety and efficacy, any drug or medical device must be thoroughly examined
through closely monitored and highly regulated clinical trials," patients
receiving medical attention should be encouraged to participate in clinical
trials.
Clinical trials benefit the scientist
the most, since it makes clear whether or not a drug will ever be suitable for
human applications. Clinical trials also help doctors decide whether, when
weighed against the potential benefits, the side effects of a new treatment are
acceptable.
Only in the rarest of cases does a
patient get affected by a drug or during a clinical trial procedure. Yet it is praiseworthy
to note that millions of people are
benefited because other people before them chose to participate in a study that
resulted in a new, more effective treatment.
Why a career in Clinical Research?
The entire process (as mentioned
above) is aided by pharmaceutical firms and a large number of expanding
clinical trial management organizations including contract research
organizations (CROs), site management organizations (SMOs), clinical data
management, knowledge process outsourcing (KPOs), investigator and site staff,
etc. These organizations demand competent and skilled work force in the
clinical research industry.
The major clinical research companies
in the area are Biocon,
GlaxoSmithKline,
Johnson & Johnson,
Astra Zeneca,
Ranbaxy
Laboratories, Nicholas
Piramal, Pfizer
etc.
In the field of CROs, the key players
are Quintiles,
ICON
International, Inc., Clintec,
Accenture,
Parexel etc.
Job roles in CROs / Pharma / Biotech Companies
[4]
- Clinical Trial Assistant (CTA)
- Clinical Research Associate (CRA)
- Senior CRA
- Clinical Team Leader
- Project Manager
- Senior Project Manager
- Manager Medical & Regulatory
- Manager –Safety / Patents
- Manager Quality Assurance
- Medical Director
- Associate Director –Clinical
- Associate Director –Projects
- Director –Business Development
- Director / Head (Clinical Operations)
- General Manger / CEO / President
Job roles in SMOs [4]
- Clinical Research Coordinators (CRC) / Study Coordinators
- Principal Investigators / Co-Investigators
- Medical Monitors
- Project Manager / Senior Project Manager
- Manager Medical & Regulatory
- Manager Quality Assurance
- Manager –Business Development
- Medical Director
- Associate Director –Clinical
- Associate Director –Projects
- Director / Head (Clinical Operations)
- General Manager / CEO / President
Job roles in DM [4]
- Data Entry Operator
- Data Validation Executive
- QA Executive
- Data Manager
- QA Manager
- Statistical Programmer
- Statistician
- Data Reviewer
- Data Base Designer
- Medical Writer
- Head –Data Management
Courses in Clinical Research
A course in clinical research,
followed by a basic graduation or post-graduation in the field of medical
science, life science, dental science, pharmacy and pharmacological science,
can definitely open up many opportunities to create a career in the industry. A
typical course in clinical research includes information about basic pharmacology
and pharmacy in clinical research, guidelines and regulations in clinical
trials, ethics in clinical research, biostats & clinical trials design,
clinical trial documents, clinical trial management, drug safety &
pharmacovigilance etc. A specialized course will generate well trained,
experienced and resourceful professionals with formal trainings in research
methodology, good clinical practice (GCP), regulatory affairs, documentation
and conducting impeccable clinical trials.
Turacoz Skill Development Program offers you with a six-month diploma course in Clinical Research
and Scientific Writing. The course gives an in-depth knowledge about clinical
research and different types of scientific documents including publication and medico-marketing
documents.
Learning Objectives:
After taking this
course, you should be able to understand the –
- Basics of clinical research, drug discovery and development.
- Protocol, informed consent form, clinical summary report.
- Ethics in clinical research and publications.
- Scientific publications and role of medical writers in scientific publication.
- Lifecycle of a manuscript - Planning, writing, reviews and finalization and submission.
- Importance of conferences and documents involved in conference support – abstract, poster and oral presentation Types of medico-marketing documents and different deliverables.
Contact Dr Smriti Khatri,
Manager of Business Development and Training at Turacoz Healthcare Solutions
for any further information or quires.
References:
Author: Madhu Kumari