Prof. AS Kolaskar, vice chancellor, University of Pune and member of the Biotechnology Task Force of Government of Maharashtra spoke to BioSpectrum about the initiatives taken by the university to introduce a course in clinical data management, an opportunity that every company is looking at. Excerpts:

What motivated you to look at clinical data management as a new course?

Looking at the opportunities, India can become a major hub for clinical trials in the world. We have enough biodiversity available here. Even people from different parts of the country stay here in Maharashtra particularly in the Mumbai–Pune belt. We have a very good hospital system. Many hospitals are interested to have a tie up with research organizations of the western world and many people are exposed to newer drugs and they want to do the clinical trials. What we require is a proper channel for collecting the data, organizing and analyzing the same. The problem we are facing is collection of data and how to organize it. Taking the consent of the volunteer is a must and that should be taken well in advance. Indians need a proper training in this sector.

Today if we see, clinical data management is not included in any syllabus. Industry particularly pharmaceutical and Clinical Research Organizations (CRO), international organizations and foundations look at clinical data management in different approaches. Within and outside the country the environments are different. It needs to be put in an organized way. In the first phase we brought international experts to sensitize a topic like which practices are used to collect the data? How it can be organized and retried for the benefit of the human kind? As different sectors like information technology, pharmaceuticals, academia, research organizations are involved in this we want to interact closely with each other before formalizing the final and regular course.

When did you get the idea to start a course in clinical data management?

I got the idea while we were preparing the biotechnology policy of Government of Maharashtra that was launched in 2001. And started collecting data on the topic. We learnt that our strength lies in biodiversity, good English speaking people and good hospital infrastructure. We also discussed at the Biotech Commission meetings to put Maharashtra on the clinical hub of the world. As an educator it gives me an opportunity to look at clinical data management as a new course. However we can download the stuff from websites and design the course. But I am not looking at that. I feel downloading won't work. Therefore my focus is to develop a proper system that should support the industry.

Do you have any fixed time frame for introducing the course?

We have just finished one workshop. The next one will be after three months. Based on the support we get from the industry we will go for the third one. Then formulate the necessary course program as a long-term policy. As the course is to be well accepted by the industry we have to have a tie up with international certification agency like CIDSC. It shouldn't become another regular course. I am looking at making it purely a job-oriented course, which will give India a global advantage. We want to create a proper environment to provide the right knowledge to the candidate in clinical data management both in quality and quantity.

When the programs of the university have been well accepted by the industry why are you looking for certification from an external agency?

There is a predetermined mindset among the industry people. We don't want to try and break these mindsets and take some time in that. I don't want India to loose valuable time in developing proper environment for clinical data management program. But the question is how we can develop India as a hub for clinical trials? There are many professionals working individually in this sector. They have experience. But they don't have the infrastructure and certification. That is why Indians are not gaining acceptance in the international market. In clinical data management authentication is a key.

What is the course design that you are looking at?

Normally it is the academia, which takes the initiatives. My interest is to take an early edge in this sector after understanding the needs of the users. Be it manufacturers, CROs all should come together and say all we need is these things from academia. Therefore we had organized the international symposium on clinical data management in mid- December to bring together the people who are actually in the field and those who are looking at this as a new upcoming sector.

The first workshop was to sensitize and to tell the industry what the university can do in this area? And how useful the program is? The second workshop should be a focused one, where we have to go in depth on each of the topics. We have to collect enough material and take the best suited. I am not in a position to hurriedly take decision by bringing some topics by selecting few from the US, UK and EU. It is a difficult task. The candidates need tailor-made courses. We can't give one course for every one. This is what Indian students are missing. Looking at the paying capability of the students and needs of the industry we are looking at short-term courses of 10-15 days, even part time courses. We have to look at various things. This can be done only when you know the candidates interests in such programs.

Some times even 3-5 days certification program will help a lot for professionals. This is what US universities used to give the students as a package. This kind of flexibility is very much essential. We have to bring in such kind of flexibility in Indian education system. We can't continue with the old system of education, which is taking more time to shift to the new system. Seeing the changes that are taking place we have to do it now and it can't be postponed. Even for designing the course material.

Should industry and academia partner?

The support of the academia is very much essential for the growth of the industry. By creating a knowledge partnership between the industry and academia, students would get proper training and know the latest industry happenings. Otherwise students will find it difficult to enter the field. They have to given in depth training. Ours is the first university to get the R& D people to its list of faculty. This kind of reverse flow is key for the success of any program. It will create new linkage in the coming years. It is not the projects from the industry that are coming into India, but the knowledge partnership between industry and academia is going to take India ahead. We have to work together. Industry tie up will help to take up the load of the administrative system. This will help the academia and the industry will be benefited too.