Clinical research is a well established and prosperous field of science across the globe and is emerging as one of the major drivers of better healthcare delivery. It helps innovative drugs and interventions for prevention and treatment of various diseases to enter worldwide market. The increasing demand and booming market of clinical research provides better career prospects.
Clinical Research and Trials
Clinical trials are experiments or studies performed in clinical research. The two goals of subjecting medical treatments to clinical trials are efficacy (to learn whether the treatment works) and safety (to learn whether they are safe). Biomedical and behavioral studies on human patients generate data related to safety and efficacy of new interventions and treatments. Clinical trials are conducted after approval from health authority or ethics committee of the country where the intervention is to be tested. These authorities or committees access the risk to benefit ratio before providing the approval which does not designate the therapy as safe or effective. Various factors that affect the clinical trials include size and cost of study as well as site of the study i.e. in single or multiple research centers and single country or multiple countries. The clinical study design ensures the reproducibility and validity of the results.
Investigators recruiting subjects with predetermined characteristics, administration of treatment and collection of health related data for a specific time period are the steps involved in clinical trials. The data collected includes sign and symptoms of the disease, concentration of the drug in the body and detection of improved or worsened health conditions. The researchers send the observations to the trial sponsor for statistical analysis of the pooled data. The final step is compilation of clinical report based on the results of the study. Few of the drugs subjected to clinical trials that meet the safety and efficacy criteria get approved.
The sponsor bearing the cost of the trial may be a governmental institute or a biotechnology, pharmaceutical or medical device company. Trial related lab work can be outsourced to contract research organization (CRO) or a private laboratory.
Clinical Research Courses and Training programs
Educational Courses and Training Programs are essential for skill development, required to secure a job in the field of clinical research. A mere degree in clinical research is not enough but skills need to be imbibed through training. Basic knowledge in drug development, clinical trial design, statistics, regulatory affairs, ethics, pharmacology, pharmacokinetics, disease diagnosis, computation skills, adverse reaction and toxicology studies are imparted in such courses or programs. There are many institutes and online training programs providing such courses. To a great extent, training in clinical research helps to build up most of these qualities and develop an insight into the field. A good training program will ensure that at the end of the course, the student is able to take up responsibilities in the industry.
The courses offered by various institutes cover topics of global market and pharmacovigilance; corporate training; market research; data management; regulatory affairs; medical and scientific writing that can be obtained by online or distance learning or classroom based educational programs. These programs and courses are mostly cost effective and affordable. The curriculums of these programs are designed in collaboration with the stakeholders in the field of clinical research, healthcare, pharmacovigilance, clinical data management, etc. The faculty of such institutes consist of industry experienced professionals. These institutes also provide active and dedicated placement support for the students.
Career opportunities in Clinical Research
Job opportunities are available in the area or department of regulation, audits, pharmacovigilance, drug development and monitoring, quality assurance, data management, etc. Clinical research assistant or associate; data entry operator; medical writer; data validation executive; clinical team leader; project manager; regulatory or safety or quality assurance manager; medical director; associate or business development or clinical operation director are the positions available in pharma companies, hospitals, clinical CRO, data management organisations, etc.
Online Course in Clinical Research
James Lind Institute (JLI) provides an online program – Post Graduate Diploma in Clinical Research that helps to better your prospects for a rewarding and exciting career in the field of clinical research. JLI also provides online courses in the field of medical writing, Pharmacovigilance, quality assurance, regulatory affairs and medical journalism.
For more information please visit: www.jli.edu.in