turacozskilldevelopment: November 2019

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
Purpose: Safety and dosage

Phase II trials:

Study Participants: Up to several hundred people with the disease/condition.
Length of Study: Several months to 2 years
Purpose: Efficacy and side effects

Phase III trials:

Study Participants: 300 to 3,000 volunteers who have the disease or condition.
Length of Study: 1 to 4 years
Purpose: Efficacy and monitoring of adverse reactions

Phase IV trials:

Study Participants: Several thousand volunteers who have the disease/condition.
Purpose: Safety and efficacy

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.