Choosing the right clinical research course

Santosh Hegde

A career in clinical research begins at the clinical research associate (CRA) level and there are quite a few institutes claiming to train industry-ready CRAs. A few pointers to choosing a good clinical research course and institute.

The pharmaceutical industry is one of the most powerful and steadily growing of all industries. Presently pegged at $ 643 billion, the industry is growing at seven percent. The single country that consumes the largest amount of pharma products (by value) is the US, and the ICH countries account for 55 percent of the world consumption of pharmaceuticals.

One of the important growth drivers for this industry is innovation and the development of new drugs. Initially, new drugs came from the plant world, later chemistry took over and presently the largest number of drugs in the pipeline is from Biotechnology. Irrespective of the source, every new drug has to undergo a series of tests: in vitro, in vivo, both in animals and man.

Before a medication can be sold in the open market it must undergo rigorous testing. The process by which new medications are tested in human beings so they can ultimately be marketed to treat various diseases is called clinical research. A molecule has to undergo various stages of testing before it can be labeled as drug.

These stages include the following:

1. Preclinical phase that can be further subdivide in to:

Development of a compound

Chemists in a laboratory develop thousands of chemical compounds with a certain chemical structure that the scientists believe may have biological activity in humans to alleviate certain symptoms in a disease, or perhaps cure some diseases.

Pre-clinical testing

The next stage of testing is called the pre-clinical stage. To prove that the compound works as is hypothesized and does not produce any unwanted side effects, it is first thoroughly tested in two to three species of animals (such as, mice, rats, dogs and monkeys). The purpose of these animal studies is to prove that the drug is relatively safe, is not carcinogenic (causes cancer), mutagenic (causes mutations), or teratogenic (causes foetal malformations), and to understand how the drug is absorbed, metabolised and excreted. Once a pharma company proves that the compound appears to be safe, and possibly effective in animals, the company then provides this information to DCGI in India or FDA in the US or TPD in Canada and requests approval to begin testing the compound (experimental drug) in humans via an Investigational New Drug (IND) application.

2. Clinical testing

Clinical trials/Studies in humans

The clinical testing of experimental drugs in humans is normally done in three phases (Phase I, II and III) starting with normal healthy volunteers and then testing the new drug on more and more patients, included in each subsequent phase. Before moving to the next phase of development the data are carefully analysed to ensure the experimental drug is at least safe and well tolerated. After successful completion of Phase III testing, a company will submit the results of all of the studies to the Drug Controller General India (DCGI) or FDA to obtain a New Drug Approval (NDA). Once the regulatory authorities grant an NDA, the company can market the drug to the public. Additional testing (post-marketing or late phase III/phase IV) to look at the rare adverse effects continues.

Careers in clinical research

One needs to have the right educational background to enter this industry. A life science degree (especially pharmacology, pharmacy, biochemistry, biology, immunology, physiology, or biotechnology) or a medical, dental or an alternative medicine degree is one of the requirements to become a clinical research professional. A computer or IT degree will be an asset to start career as a clinical data manager.

Clinical research Asssociate

A Clinical Research Associate (CRA) is a professional who monitors the administration and progress of a clinical trial on behalf of a sponsor. A clinical trial is a scientific study of the effects, risks and benefits of a medicinal product, including new drug substances and currently marketed drugs. A CRA is also called a clinical research (or trials) monitor, executive, scientist or coordinator, depending on the company.

Typical work activities include: locating and briefing suitable doctors/consultants (investigators) to conduct the trial; setting up the study centers — ensuring each center has the trial materials and checking that the investigator knows exactly what has to be done; monitoring the trial throughout its duration which involves visiting the study centers on a regular basis to check the patient data in the case report forms (CRFs) and to sort out any problems which may arise; validating and collecting completed CRFs from hospitals; closing down study centers on completion of the trial; discussing results with the statistician. Writing technical reports on the trial is usually carried out by a medical writer.

The job of a CRA can vary tremendously from company to company. In some companies, the candidate would be involved in the whole process - from sitting down with the doctor who has the idea for a trial, and actually working out a protocol, to writing up reports after the analysis has been done. In other companies it would be the medical adviser who initiated the trial and the CRA could just be involved in collecting data once the trial has been set up.

The CRA will need to work extra hours regularly, generally, a limited amount of time is spent in the office. The work is mainly on the road visiting trial centers, general practitioners (GPs) or hospitals; dealing with doctors and research nurses.

Entry requirements

A fresh candidate would be more likely to enter the field as a clinical data coordinator. These are generally jobs that deal with the data handling/co-ordination part of the CRA's job without the involvement of initiating and designing the trials. Experience in this type of work would generally qualify the candidate to move on to a CRA position.

Professional Training The Clinical Trial Management Program is a program designed to provide a focused course of study for individuals seeking to prepare themselves for clinical research in the pharma trials industry as a clinical research associate or a clinical research coordinator.

Clinical research education

The last five years saw a notable growth of clinical research training courses in all parts of India. These institutes are of varied types, some belonging to private entrepreneurs, private companies, universities and trusts. Since there is no national or international standard of education or syllabus, the courses vary in length, content and relevance. The offering by different institutes in terms of certificates of completion differs widely. While most offer a package of what is termed as Clinical Research, some institute offer courses in clinical data management, quality assurance, business development, regulatory affairs, all concerning clinical research only. A summary of institutes providing courses in clinical research is given in Table 1.

Going purely by numbers, there are a large number of institutions involved in clinical research education though the ground reality differs. Presently there are no guidelines for suggest facilities and requirements for clinical research education. If they were to be formulated, most institutes in India would not be found compliant.

It was for this reason that Bilcare Research, an industrial house involved in pharma component manufacture and research entered the field of clinical research education. Bilcare set up its first campus in Pune, and its goal in entering this field was simply to set a global bench mark for clinical research education.

In setting up this academy, Bilcare had a unique advantage. Since a number of institutions had been set up earlier, Bilcare could learn from their experience, what should and what should not be done. The overall set up of Bilcare is therefore the result of the vision of Bilcare's management and lessons from other institutes.

Salient features of the Bilcare Research Academy

• Bilcare Research Academy provides a controlled temperature environment which makes studying not only comfortable but an enjoyable experience.
• First base in educational center of Pune, surrounded by colleges and University of Pune.
• Faculty at Pune and Bangalore together has a combined experience of over 125 years which covers preclinical and clinical research both in academic institutes and the pharma industry.
• Optimum student teacher ratio— Most institutes in India have a student teacher ratio exceeding 50:1, while at this level the desired ratio is 10:1.
• Well stocked library
• IT Facilities— Each student provided with a laptop, entire academy is wi-fi enabled
• Teaching aids include interactive white boards, videoconferencing facilities and interactive boards
• Association with Bangalore Diabetes Hospital, where students get practical exposure to clinical research as it is pursued by diabetologists attached to this hospital..
• Affiliation — The decision to seek accreditation from the Association of Clinical Research Professionals (ACRP) was based on ACRP's world wide reputation as a professional body that trains, certifies and accredits clinical research professionals. ACRP stands out as a body that is recognised by regulators, sponsors and investigators all over the globe.

Partnership with ACRP

The association of BRA with ACRP is a unique one. This association signals the entry of ACRP in the Asian subcontinent, and Bilcare will be the face of ACRP in this region. It will represent ACRP in all countries except Japan. The good work that ACRP has been doing in US and Europe would now spread to other parts of the world.

The partnership between ACRP and Bilcare would be a dynamic one where ACRP would be an active partner in Bilcare's training programs. ACRP will be involved in finalising the syllabus, teaching and evaluation methods as well as in certification of students on successful completion of the course.

The involvement of ACRP in teaching program will include webinars and lectures from ACRP associates being beamed directly to Bilcare's centers in Asia. This will give students a direct and quick access to new emerging information, be it industry or academia centered.

The pharma industry has already recognized the role of ACRP in training and certification of professions. Leaders in drug development have announced that professionals working on their research projects would have to be certified by ACRP. With the spread of this trend ACRP will be on the way to become an international certifying body. Such a move makes a lot of sense, since research methodology all over the globe is becoming identical; there is little sense in having regional or national bodies doing the certification work.

The first campus of Bilcare Research Academy has already begun functioning; it was inaugurated by Thomas Adams, President and CEO of ACRP on June 23rd 2007. The inauguration of the campus was attended by the who's who of the Indian pharma Industry, along with the then Drugs Controller General of India, Dr M Venkateswarlu.

The second campus of Bilcare Research Academy was inaugurated by Dr John L LaMattina, then Senior Vice President, Pfizer and President, Pfizer Global Research and Development. The Bangalore chapter of ACRP was launched by Thomas Adams President and CEO of ACRP on 17th December, 2007. Usha Ganesh, the Additional Chief Secretary, Government of Karnataka was a guest of honour during the inaugural function.

Student profile

The first batch of 48 students of BRA in Pune is an even mix of physicians, pharmacists and life science graduates. An analysis of second batch shows that the number of physicians has gone up while that of life science graduates has come down, a trend that is seen in Bangalore too. Eventually we would probably reach a student mix with a majority of them being physicians and pharmacists and life sciences forming a minority. Such a mix is quite different from the US where nurses form the bulk of CRAs, CRCs and monitors.

The first batch of students is now passing out of the Academy and is finding placements among the best pharmaceutical and contract research organisations both in India and in the US. Our students have been quickly picked up by companies such as GCS, USA, Quintiles, Sanofi Aventis, Amgen, Lupin, Icon, Siro, Chiltern, Cognizant and Serum Institute. In a large number of other organizations the procedures are in progress but have not been completed. Over half of our students have already been placed while selection process and placement for the rest is on.

We hope to contribute to this fast growing industry by producing globally competent, knowledgeable and high quality clinical research professionals.

(The author is President, Clinical Research Services, Bilcare Research Academy. He can be contacted at santosh.hegde@bilcare.com)