Racing to the top

Racing to the top

With the surge of clinical research (CR) in India, the dearth of adequately trained professionals could seriously hinder the reputation and growth of the CR industry in India. The fact of the matter is that India cannot afford to be left behind and let the CR opportunity pass on to other countries. Aashruti Kak finds out what is not going right… (Extracted from Express Pharma, 16-31 January 2008)

Gradually changing healthcare policies and a maturing regulatory environment have led India to rise as one of the fastest growing and most important nations for the future of clinical research (CR). But the question still remains—Are we ready for it? Do we have adequate clinical research education to train students into the country’s (and the world’s) best CR professionals, and what in reality is the demand for CR education in the country?

“When we talk of meeting educational demands, we can look at it from two different perspectives,” says Dr Suresh Menon, President, Indian Society for Clinical Research (ISCR), an industry body of CR professionals. “First is from the perspective of the student community. Considering the height of clinical research that has built over the years in the recent past, I think that the demand is pretty high. Also considering that this provides a number of opportunities for life sciences graduates, they are attracted enough to jump on the bandwagon.” He adds, “From the perspective of the clinical research fraternity, the CROs and the sponsors etc, it is obvious that they require people who are qualified in clinical research.”

S K Gupta, Dean and Director General, Institute of Clinical Research in India (ICRI) says, “India is progressing at a fast pace in the clinical research sector. About 300 clinical trials are being conducted in the country, most of them being multin-ational. This requires a huge number of clinical research professionals, and hence, high quality educational institutes.”

Even the pharmacy university curriculum doesn’t provide enough exposure or potential for the scope of discussing topics in CR. This gap exists primarily because clinical research as a potential has only evolved in the last couple of years. There have to be inclinations on the part of various universities to include this at the start of the curriculum. “That would possibly be the way forward, as clinical research finds a better place in pharmacy and pharmacology curric-ulum in medical colleges etc. That’s where we need to go from because that has the sanctity of the university degree that the student possesses,” says Menon. But currently, that is not the case. “Now this gap is trying to be filled by these private so-called clinical research institutes, and there, obviously, the commercial concerns are over the need to have students fully equipped with the knowledge that would count them in as good clinical research professionals,” he adds.

In favour of the CR institutes, it must be said that the kind of packages that they have designed for their courses, full time or part time, are quite elaborate and extensive. They have made efforts to ensure that the whole gamut of CR is actually covered in the process. “That, in fairness, we will have to admit because they have constantly been in touch with industry as well, and before they put a final seal of approval on their course curricula, they have had extensive interactions with industry and academia. So that is a very good part of the whole design,” states Menon.

Raising the bar

The country is in desperate need for well educated and trained CR professionals. It is not that present CR professionals do not get any training, but even the best available training seems to fall short of the evolving needs of the CR industry. Menon explains, “When you look at the standard of education, there are some gaps; again because we do not have fully dedicated people out there who will actually have full knowledge about the industry. Basically, it is again depending on the industry, and there, we have quite a variation in the quality of the people who would be training the students.”

Although there may be some exceptionally qualified people training students, there is still a chance of a compromise where the faculty may not qualified enough or certified to teach. For instance, in a university, or a medical school, teachers that are involved have to comply with certain minimum standards to qualify. That is not the case with these institutes as they may or may not pick up CR professionals who are experts in the industry, and there, the gap exists regarding the standardisation of the faculty. “The fact is that the curriculum is extensively drawn up, is by and large elaborate, and is designed according to the Indian standards and the needs of the Indian clinical research professionals, but having said that, the faculty has to be standa-rdised,” says Menon.

Connecting the missing links

Menon says, “Much more important than what we have been discussing is the fact that no CR professional getting out of these institutes has been able to perform from day one, especially because they don’t have hands-on training.” This is a very common lament that most CROs/pharma companies voice, adding another point in the list of inadequacies in CR education. “An institute should provide a blend of theoretical, as well as practical experience. Having workshops, hands on training, mock trials and industry exposure is very essential. For instance, ICRI provides all aspects of the training in CR. Four months exposure in the best industry during the course fulfills all aspects of education in the industry,” says Gupta.

Dr Medha Joshi, Principal, Bilcare Research Academy, Bangalore, says, “A clinical trial management course should have theoretical aspects with hands on training by integrating novel teaching learning methods along with the didactic lectures.” For instance, in the couse offered by Bilcare Research Academy, the curriculum is divided into 14 modules and each module has active learning elements incorporated into them in the form of simulated cases, assignments, role plays, journal critiquing, presentation and seminars by students etc. “This will help students apply the theoretical knowledge to real life situations. The students will have an opportunity to witness and participate in various activities associated with clinical trial management because of Bilcare’s association with Bangalore Diabetes Hospital (BDH),” says Joshi. BDH has a research wing where many clinical trials are being conducted. So, the students will have an opportunity to observe the various elements of clinical trial management at close quarters. This will give them a first-hand experience of clinical trial management. The students will be placed in a hospital/CRO for two months of internship after the course.

The other side

A lot of CR institutes approach pharma companies to provide opportunities to students who are under training, which has not really been possible because of the workload that these companies handle, plus the confidentiality that comes with data and clinical studies. Menon says, “Everything has moved towards automation. Everything is online, and giving these people access to all that information is very difficult. And if they do not get that access they are not getting adequate exposure then as well. So, there are some nagging doubts which will always be there.” Because of different systems, processes, approaches and the work environment in companies it becomes really complicated to allow trainees to work there. Even basic infrastructure including space, is just not available on the part of the sponsors to accommodate the amount of students. “All put together, what

happens is that the industry is also not really inclined towa-rds accepting these students to the extent that too many students are being churned out. They may be able to take two or maybe four students in a year, but that wouldn’t mean that they are providing the same opportunities to the vast majority of students coming out of these institutes. It means that they do not get a full baked clinical research professional,” says Menon.

Another thing is that CR is a very unique specialty. Menon explains, “If a CR professional is sourced from some pharma company or a CRO with the experience of one or two years, the processes that the CRO follows will be slightly different from any other company, and obviously no CR professional, irrespective of his/her position or experience, is expected to deliver from day one.” Each company has its own internal processes that will take the professional thro-ugh an extensive training programme, expose them to the basic tenets of ICH-GCP and make them familiar with the company’s products and features. So, such opportunities are not only offered to a fresher but also to experienced professionals. “The only solace that these instituites provide is in the mere fact that those who have undergone the course would want to have a career in CR. It is indication enough that there is a prospective candidate waiting and wanting to make a career in CR,” says Menon.

Being there first

With the increase in the number of clinical education institutes set up across India, it has becomes quite confusing for a student to differentiate the good from the not-so-good and choose the right institute that will provide adequate training to him/her. In such a scenario, where does the student go? It seems that being there longer than the others in the CR education scene can make it easier for institutes to get students more quickly. For instance, institutes like ICRI have definitely got an upper hand over the rest of the CR institutes. Gupta says, “ICRI is the pioneer institute in the country, which has produced more than 3,000 professionals in the country and is working in the top pha-rma industry of the country. Thus, it has the distinguished position in the CR education scenario.” Along with the established name, what also matters is the accreditation, duration of the course, qualified faculty, infrastructure, and most importantly, hands-on training, among others.

Global industry-academia partnership, for instance, the recent ICR (UK)-ISCR tie-up, is also another way CR education in India can get a big boost by the way of sharing knowledge and raising standards of education.

As all companies have their internal training in place, the institutes should focus their course designs more on the ongoing practical issues in the Indian, as well as the global industry.

The ideal CR professional

According to Menon, an ideally trained professional should know the basic tenets of ICH-GCP. He should know the various stages involved in setting up a clinical study. He should know what is involved in the whole gamut of a clinical study from the initial stages to the last steps. In addition, computer literacy is very important and personality traits also matter a lot. “Good communication skills, the ability to plan and organise, prioritise and multitask, these are the attributes that we look forward to when in search of a good CR professional,” he concludes.