clinical research carear

A graduate in life sciences or medical sciences is often at cross roads after completion of his/her degree. Many of them are not confident of their career and are anxious about their next move. They are often undecided on whether they should pursue a postgraduation in the same subject, prepare for foreign university exams, accept jobs offered with a decent salary irrespective of the nature of the job or try something different that is more challenging and satisfying.

There is also a category of students who are neither content with their graduation nor happy with the type of jobs offered to them. With the rising cost and competition, they are also not confident of pursuing post graduation in the main stream. It is this category of students, mostly venturing into trying something more challenging. In such a scenario, advertisements like 'Clinical research the emerging career option for lifesciences, dental and medical graduates', will certainly stimulate the students to consider clinical research as their destination. Furthermore, the terms Clinical and Research makes this field an attractive option. For many of the science graduates aspiring for growth, research is a boon because science and research are inseparable. When research offers an attractive salary too, guardians and parents are obviously drawn towards the field. The journey of exploration thus begins. The students and the parents discuss with the institutional heads and end up taking the course. Many succeed in this attempt and get their ambitions fulfilled. But there are some who become miserable because they could not achieve what they aspired for.

What were the reasons for such failures? Is clinical research a feasible option for all the life science graduates? Does it offer highly paid jobs as claimed by the advertisements? Are the job opportunities really in plenty? How can the course equally fulfil the aspirations of medical and non medical graduates? These are some queries which have to be answered so that students genuinely interested in challenging but emerging areas are not misled.

Through this article, an attempt is made to clear some of the myths and put forth the facts of careers in clinical research. Before we actually get into these issues, let us first understand the basic concepts of clinical research.

A multi disciplinary effort

Clinical research is applied research. In simple terms, it involves testing of new medication in human population. The purpose is to evaluate whether the medication is safe and effective when it is used for the disease under question. Clinical trials also tell us what is the appropriate dose and route of administration. The whole task of clinical trials is carried out in a phased manner. Initial testing called Phase-I is carried out on healthy volunteers to understand the safety profile and observe how the body handles the drug (ie pharmacokinetics). The subsequent phases, Phase-II and III are carried out on patients suffering from the disease to understand the efficacy (whether it really works) and safety of the medication.

As clinical trials involves research on human subjects, it has to be performed to the highest standards. Ensuring clinical trials are performed in accordance with national and international guidelines of Good Clinical Practice (GCP) is a combined responsibility. Trials cannot be conducted without the approval of the regulatory bodies (Drug Controller General (India)) and Ethics Committees located at the institutions performing the trials. Such scrutiny is intended to protect the safety and rights of the patient. Clinical trials are conducted on thousands of patients who volunteer themselves to participate in the trial after fully understanding the purpose and rationale behind the research (called as informed consent).

After completion of all the phases, the regulatory agency reviews the data obtained from thousands of patients. If the medication proves to be effective without causing much of side effects, permission is granted to market the product. However the pharmaceutical manufacturer (sponsor) is expected to monitor for any new risks/side effects even after the drug is marketed. Generation of quality data (observations on the patients like blood pressure) by the physicians (investigators) is the fundamental and crucial component of clinical research. The sponsor with his team supports the investigators in such activity. Each investigator carries out the actual clinical trial at his site (hospital) and the sponsor's team co-ordinates trials initiated simultaneously at various centres. Preparing clinical trial documents (the protocol, case report form etc) ,monitoring the trials at regular intervals, quality assurance, audits, supply of tested drugs at desired time are some of the important responsibilities of the sponsor. However the investigator dispenses the medication, obtains informed consent, ensures safety of the patient through follow ups and attends to the patients whenever there is an adverse event. Thus a collective and well co-ordinated effort of sponsor and investigators team results in good clinical trial management, which is crucial for the successful outcome of clinical trials.

Behind the curtain

Research would have started at least four to five years before the drug was tested on humans in the research and development centres of the sponsor. The diseases that are unaddressed or are yet to find a good medication with fewer side effects are first identified. Research is then carried out to understand the molecular targets that need to be rectified by drugs. With this information, drug discoverers synthesise chemicals and identify the suitable candidate molecule through sophisticated technologies like high through put screening. The probable candidate is then put for further pharmacological and toxicological testing in experimental animals. The molecule is then subjected to clinical trials. The cost of drug development is approximately $1.2 billion and it takes about eight to 12 years for the drug to reach the market from the time it is discovered.

The clinical research team

At the Sponsor/Contract (Clinical) Research organisations (clinical research organisations are independent private companies to whom the sponsor sometimes outsources the clinical trial projects): Clinical Research Associate, Clinical Trial Administrator, Project Manager, Medical Writer, Quality Assurance Manager/ Eexecutive, Medical Advisor (These positions are exclusively for medical professionals, the rest are available for any lifesciences graduate/post graduates), Medical Monitor, Data Entry Operator, Data Manager, Data Validator, Bio-statistician, Manager- Regulatory Affairs.

At the Clinical trial site

Principal Investigator, Co-investigator, Clinical Research Co-ordinator, other hospital staff as per requirement

Companies into clinical research Sponsor companies: Johnson & Johnson, Biocon, GlaxoSmithKline Beecham, Allergan, Astra Zeneca, Ranbaxy Laboratories, Nicholas Piramal, Dr.Reddys Laboratories, Novo Nordisk, Pfizer etc.

CROs: Quintiles, Manipal Acunova, ICON International, Clintec, Clinigene International, Accenture, Paraxel, Asian Clinical trials, Paragon, etc.

Hospitals : St.Johns Hospital, M S Ramiah Memorial Hospital, Kidwai Memorial Hospital, Bangalore Institute of Oncology, Bangalore Diabetes Hospital, Wockhardt Hospital, Apollo Hospitals etc.

Information technology and clinical research

Information technology has been a boon to the clinical research industry. The software programmes such as Oracle data base helps the organisations to effectively manage huge amount of clinical trial data. Since we have several thousands of patient's data using software makes the job easy andgenerate high quality analysis. Clinical data management has thus emerged as one of the important off shoot of clinical research. There are many other applications of computers in clinical research, the discussion of which is beyond the scope of this article.

Role of training

Every player in clinical research is expected to be a responsible and committed manager. He /she must be quality conscious, willing to take responsibility, have self discipline and must be willing to be a team player. He must also have a good communication skills, the right attitude, be able to build up good interpersonal relationship and be easily adaptable. There should be a sound fundamental knowledge of common disease conditions, new drug development, GCP, regulations and ethics. He should be able to draft some of the documents, interpret any clinical trial document and have an eye for details.

Training in clinical research to a great extent helps to build up most of these qualities and develop an insight into the field. However, it always depends upon the quality and the methodology of training and trainers' experience in the field. A good training will ensure that at the end of the course the student is able to take up responsibilities in the industry without further training by the employer where he would be eventually placed. Hence it is not sufficient to have an ambition to do a course in clinical research but also to choose the right institution. Aspiring students should collect information through internet, past students, through personal visits and interaction with the teaching faculty.

Choosing the right institution

A good institution will alone guide students towards the right path. The following points are crucial to be considered while selecting the institution.

• The management: A sound management with a good track record in any field will be a stable organisation. The management with a right attitude and mission will always be pro-students. Students in such institutions are well protected
• The infrastructure: The student oriented institutions always provide good amenities to students like classrooms conducive to learning, adequate library facilities (adequate enough for all the students), good student faculty ratio, work space, counselling rooms etc
• The faculty: It is extremely important to select institutions with faculty who are qualified, well versed with teaching methodologies and well experienced in clinical research training. An institution that can afford to have at least one such faculty for every 10-15 students will certainly give quality education. Further, there should be a regular inflow of guest faculty from industry
• Placement records: A good placement record indicates acceptability of students by the industry. It also indicates that the institution has a cordial relationship with the industry and has taken into consideration the industry needs. With the mushrooming of training institutes, employers are becoming institution-selective. It is no longer sufficient if you are trained but the institution that trained you becomes an important criteria for placement
• Affiliations/ accreditations: The body accrediting the degree should be acceptable to the industry and have high standards and curriculum that caters to the needs of the industry. Therefore prospective students are expected to interact with industry professionals through contacts before taking admission
• Training methods: A sound theoretical knowledge is a necessity to understand the rationale behind the various processes in clinical research. Training methods in addition should also include hands on training in as many areas of clinical research as possible. Simulations, exercises, case studies, role plays, assignments, visits to clinical research units and R&D centres, projects etc should happen as a part of training. The student must ascertain whether the institution is able to provide such an atmosphere. This information can be gathered by an interaction with students already pursuing the course.

Opportunities in Clinical Research

One of the questions frequently asked is 'are there really good number of jobs to all the clinical research students passing out of the course?' Yes, there are jobs available, but one must be able to move out of their town for a prospective career. Secondly, the students must be able to come up to the high expectations of employers. A mere degree in clinical research will not suffice. There has to be an active effort by the student in understanding the subject and improving his soft skills. If students are sincere in these aspects, with a little patience they are guaranteed to be placed.

At times, it is very disappointing if sincere students are not placed after they have taken up the course for a career change. They have also been promised a very fat salary during admission. Such students are already in a good position doing well in their jobs. It is not advisable to opt for a career change at this stage because they are freshers in clinical research. The work experience in any other field will not be considered. Such students will be utterly disappointed as the salary will not match up to their expectations. To conclude, a career in clinical research is definitely challenging and satisfying. However success is ensured only when one chooses the right course from the right institution after thorough homework.