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Careers in Clinical Research

How to Start a Career in Clinical Research in India ?

In an attempt to address the spiraling cost of developing new drugs and address the fact that many European countries and the US are demanding drugs at a lower cost, major pharmaceutical companies have recently had to re-evaluate their product development strategies. “Central to these changing strategies is the ‘globalisation’ of clinical research — the conduct of studies requiring patients from all ethnic groups in all countries with the aim of increasing the speed and efficiency of these studies,” states Anthony Woodman, UK campus director, Medical University of South Carolina (MUSC). As a result, the clinical research industry today requires a great number of clinical research professionals in every country. In Asia alone the market is worth more than US $2.5 billion. Professionals in demand include medical/dental trained investigators/coinvestigators who are in charge of administering new formulations supported by pharmacology; pharmacy, life science and biotechnology graduates who can facilitate studies by managing clinical sites, clinical trial co-ordinators (CTC) who are in charge of procuring patients, clinical research associates (CRA) who are essentially data and site monitors and clinical data managers. “Understandably, all these roles need support from contract negotiators and business development professionals,” informs Woodman. Each of these positions are required in countries where clinical research is conducted. “However, a key fact is that 70-80% of global clinical research is initiated and funded by companies based in the US or Europe and are home to major regulatory authorities (US FDA and European Medicines Agency),” he adds.

INDUSTRY OVERVIEW

The global clinical research industry is worth more than US $52 billion. The global pharmaceutical market is estimated at US $427 billion and research and development cost is estimated at US $60-65 billion annually. Two-third of this amount is spent on drug development i.e. approximately US $40 billion. Clinical trials involve almost 70% of time and money of new drug development. Cost of conducting clinical trials for a new drug is approximately US $200-250 million. Clinical research industry has grown around the world at an unparalleled rate in the past few years. It has opened up new vistas of employment for a large number of people. The clinical trials market worldwide is worth over US $45 billion and the industry has employed an estimated 2,10,000 people in the US and over 70,000 people in the UK. They form one third of the total research and development staff. The average nominal annual salary growth across all positions is 4% as against less than 1% for four segments.

CAREER SCOPE

Informing on specific career opportunities against this backdrop, Woodman states, “Clinical research requires professionals who can work across countries as project managers, technical writers, regulatory affairs professionals collecting and collating data for the sponsor pharmaceutical company or clinical research organisation (CRO). These professionals need global skills, global knowledge and global insight to the sector. Consequently, these positions require knowledgeable, flexible and well-travelled individuals who in turn receive competitive packages.” Talking about how career opportunities in clinical research compare and contrast to career opportunities in healthcare, Woodman says, “Both careers offer considerable opportunity to work on a global scale. Given the fact that the phenomenon of global expansion is both new and rapid, there is considerable demand for graduates with broad skills and knowledge. It will be fair to say that both clinical research and healthcare administration offers the same opportunit i e s. However, the focus and required skill-sets do vary.” Explaining further, he continues, “Clinical research attracts graduates motivated by new discoveries and an eye for detail and in the case of medical/dental professionals a desire to maintain a career with patient contact. Healthcare administration requires strong leadership combined with technical knowledge and a motivation to benefit patients through the provision of efficient, cost-effective healthcare.” He further adss, “Respecting these differences it is important to understand that both clinical research and healthcare administration share a common objective — ensuring that the human race as a whole does not suffer the ailments suffered by our parents and grandparents. Consequently, professionals associated with these allied domains (clinical research and healthcare administration) should understand that people across the world expect to receive safe and effective drugs in modern hospitals.” People are also conscientious that the healthcare standards of these hospitals accrue to international standards of care and safety. Most importantly, people expect all this to be cost-effective. If this understanding is fostered, professionals in both these allied fields will be inspired to ‘think out-of-the-box’ and compare and contrast processes and systems across the world, which is a critical need of the hour.

FUTURE PERFECT

Globally, the healthcare industry is expected to be the largest industry by 2015. Talking about future expectations from this industry, Woodman says, “The advancements and sophistications of this industry should spread evenly across the world. Therefore, looking at clinical research or health care from a geographical perspective is no longer relevant. The upcoming professionals in this field are required to be global citizens possessing global skills and strong local knowledge.” He says that in order to gain local knowledge, professionals should retain their identity while exposing themselves to diversities of social and professional cultures.