We are the only country providing formal training for clinical trials'

Professor Christoph Thiemermann, CEO, William Harvey Research Limited (WHRL), UK, gives an insight into WHRL's collaboration with CREMA (Clinical Research Education and Management Academy) and more on international research education trends and education in India, in conversation with Arshiya Khan

What was the rationale behind WHRL's tie up with CREMA?

We are into clinical research and also teach medical students. When we were approached by CREMA, we looked at the curriculum and felt that there was a need for the course because none of us involved in clinical research had had formal training. So we were medical directors or XYZ at some pharmacetuical company and followed protocols as set by somebody else, so we had to learn how to do it.

Will this collaboration give any accreditation to CREMA?

No. We will only provide guest lecture faculty to CREMA who are experts in their field. These guest lectures may be from the Queen Mary University, London or from the US or Europe. This will give an international label to the teaching here in India. There may be faculty coming to provide lectures on ethics, somebody who looks after the European Medical Agency etc. As far as accreditation is concerned that's not something that we are talking about today, as it is a very new course.

How will this collaboration progress and what will be the frequency of the lectures?

We are going to be sending two or three people every year for a week at a time to teach at every campus of CREMA i.e at Bangalore, Delhi and Mumbai. But the number will vary as when the number of students goes up, more time will be needed.

What benefits does it give WHRL?

At the moment, there is a financial commitment but any profits that are made would be used to do more research. Before the tie up with CREMA, we spoke to pharma companies if they wanted to work with us in some way. What drew us to CREMA is that CREMA is an Indian standard of teaching.. CREMA will train students and so it gives us the way to contact, or to get in contact with a number of small and large pharma companies in India. And this was our major motivation in tying up with CREMA.

Does WHRL have any other similar tie ups with any other institutions in other countries?

No. In terms of teaching, clinical teaching and clinical trial teaching we are committed to CREMA and that's the only tie up we have. We conduct pre-clinical contract research, we do contract research in any given year with about 20-30 different companies and that's all over the world. We have more biotech companies and also big MNCs like GSK.

What is the reason for choosing India and CREMA?

There is no other organisation in India who offers this type of course in pre-clinical trials. Though there are two other organisations in India doing something on the same lines, we were contacted by CREMA. We got introduced to CREMA through the British Council i.e UKTI office (UK Trade and Industry). We told them of our interest to be involved in the clinical trial teaching arena and after negotiations we finalised the deal.

Will the students trained at CREMA be placed in WHRL's CRO?

There is no definitive agreement. It is not really a CRO in the sense that WHRL doesn't do any clinical trials. We only do pre-clinical trials. So there is no agreement in place that we would take all the students or they will be a part. However if there is a trial going on and a student wishes to come to observe and help in that trial at that time, then it is something that can be definitely thought about.

Has the institution also tied up with any other research institutes or government body, in India or else where in the world? Is there any MoU in the pipeline?

No, this deal is exclusive in a way and we have no intentions of tying up with other organisations in India to do clinical trial teaching.

Is the clinical research industry/education in India different from that of Europe? What are the plus and minuses of the Indian Clinical Research industry in terms of education? How can that be built upon?

I think the question should be turned around. There is no ethical pharma training in Europe and in the absence of one I think we are leading. And in fact we are the only country providing formal training for clinical trials. And unlike in other countries where they have small certificate courses or computer based training and they are certified. In UK it's the ICR (Institute of Clinical Research), UK. In America, the American Clinical Research Professionals (ACRP), conducts small time training programmes or computer based training programmes which are later certified. After having realised the fact that clinical research is booming and there is a new paradigm and new business, we have an advantage here as we specifically train people to have the skills and attitude necessary for clinical research as a profession.

Accreditation is quite difficult as they still have to familiarise themselves with the teaching and the topic which they have not done in the past. So I think accreditation will take place in future. There is also a possibility that CREMA or another body in India could teach in Europe and or have similar courses.

A large number of clinical research training institutes have mushroomed to take full advantage of the predicted boom in the clinical research and trials industry. What will determine which institutes stand the test of time and survive the competition?

We have many fly-by-night operators to start such courses. I think over the last few years, there are very few established institutes and organisations. We have CREMA, ICRI, and ACRP. Others are likely to do tie ups or will probably merge or operate in certain regions, not at an all India level. Secondly, people who will stay in the industry are people who have started with a clear vision and a mission of ensuring that you are at the finishing school. And for people who come from other institutes and wish to be employed with this organisation are those who have missed that finishing touch.

So ideally organisations like CREMA who serve as a medium between the industry and the academia are here to stay.

What are your future plans in terms of evolving new courses, specialisations? Which areas would they be focused on?

We recognise that clinical research is a booming industry. And therefore we went ahead and started with clinical research project management, data management, pharmacovigilance, medical writing and clinical trial supplies management. And all of these are getting to be recognised as separate identities requiring special skills. Therefore we are starting with special courses. But these five streams are the ones that we will focus on before we move on. Since we don't have the benefit of existing US or UK based learning programmes, we will start sharing practices with India and say that this is what we require and then exchange notes with others.

What are the international trends in clinical research education/training?

Internationally also we will be looking at the core areas mentioned above. But, India started its foray into outsourced work doing only medical transcription earlier during 2002-2005. We moved on being a Business Process Outsourcing (BPO) organisation doing minimal value add work till recently. We are now considered and acclaimed for medical writing and pharmacovigilance, a definite value addition - KPO a Knowledge Process Outsourcing organisation

Clinical Research is a sunshine industry that spells an opportunity of 50,000 jobs by 2010 in India alone and more than 2,50,000 jobs globally.

Before each medicine makes it to the market, it has to pass a lengthy approval process in which many Clinical Research Professionals are required. CREMA – Clinical Research Education and Management Academy – is a premier training & research institute in Clinical & Biomedical Sciences.