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Event to focus on regulatory landscape of clinical trials

Thursday, February 5, 2015, 08:00 Hrs  [IST]

Dr. Renu Razdan, member of Organizing Committee for BioAsia’s Clinical Research Conference, COO of Max Neeman International, India and Vice Chairperson for Association of Contract Research Organization (ACRO), in an online interview with Amguth Raju, shares her views on clinical trials industry in the country and ACRO’s focus at this year’s BioAsia.

ACRO being the co-organizer of the clinical research conference at BioAsia, what will be the key focus?
The key focus will be on Indian regulatory landscape, its challenges and improvement expected. It will also address the challenges and solutions in conducting clinical research. We also expect that participants will be working with local and national regulators to further improve the systems and processes for clinical research in India.

How significant is clinical research in the development of new drugs?
The development of new and useful drugs is important to improve the quality of drugs therapeutics and to ensure that better medicines in terms of effectiveness and safety are provided to the people. Clinical trials play an essential role in the development of new drugs. Clinical trials generate evidence contained within treatment, practice guidelines and this has a much larger reach throughout populations. All the phases of clinical trials like Phase 1, Phase II and Phase III are important, however, clinical trials conducted after the drugs approval along with safety reporting and Pharmacovigilance provide additional information about the drug and its usage. As is well known, if we want to benefit from the medicine, we must also accept some risks and more often the benefits significantly outweigh the risks.

Globally how big is the clinical research industry and which are the countries that are leading in this segment? Also tell us about India’s role and its market share in this segment?
Globally the clinical research industry is around US$ 20 billion and is estimated to grow at a CAGR of 7-8 per cent per year. The countries which are leading in this segment are North America, USA, Canada, Germany, France, UK, Italy, Spain, Netherland, Korea, and China. India’s market share in clinical research industry is small in terms of size and the market for clinical research in 2012 was US$ 425 million. Compared to USA where number of trials conducted till Jan 2015 is around 82,232, India only got approval for around 2575 number of clinical trials.

How big is the market for clinical trials in India and what are the possible opportunities that can be explored in this segment?
India can largely benefit from participation in drug development and clinical research. Not only clinical trials but also other areas like lead generation, pre-clinical development, statistical analysis and medical writing are other segments that can also grow as a result. In additional ancillary services like clinical laboratories and core laboratories can also largely benefit from increase in clinical research.

As the Clinical Research Conference will focus on whether India can regain its position as global leader in clinical trials, what according to you are the challenges and opportunities of this segment in India?
One of the major challenges is the delay in getting approvals. The industry would like to see the improvement in the timelines for approvals as this impacts various activities for drug development. India is far behind Western and other Asian countries for granting approvals.

Could you throw some light on some of the ethical issues and what according to you are the possible solutions to resolve these issues?
ACRO stands for ethical conduct of clinical research and its members do not compromise on the quality and ethics associated with clinical trials. Both at industry and regulators level there should be enough checks and balances and systems in place to ensure that any deviations are addressed by the systems and appropriate actions; both corrective and preventive is adopted.

How do you view the regulatory environment for clinical trials in India?
There is a significant improvement compare to last two years. However, there is a room for improvement in terms of implementing the decisions and recommendations of various committees and bodies. We would like to see improvement in timelines and involvement of scientific and medical person in decision-making at regulators level.

Do you feel that awareness level among common public about clinical research is low? Will the conference do anything to address this aspect?
Yes the Indian population needs to be educated about the benefits of clinical research. This effort is an ongoing one and cannot be accomplished in a short period. Therefore various platforms should be used to update and make Indian public aware about clinical research. The awareness program should be scientific and data driven. This should ideally be done under partnership with Government, industry and also at hospital level.

How do you view the government support for clinical research in India?  Do you think the recent ‘Make in India’ campaign will help to restore confidence among investors in this segment?
The current Government is proactive and the industry is looking forward to swift implementation of key changes leading to confidence of international pharmaceutical companies and also key investors. It will take a lot of efforts on part of the industry and Government to restore confidence of international companies in India.

How do you view the funding scenario for clinical research in India?
This is never been an issue. However, the challenge is the implementation of key initiatives / changes.

Overall how do you look at the future of clinical research industry in India?
We as a body are optimistic and have a lot of expectations from the current Government. We as an organization have worked and are willing to work further to enhance our involvement to project India as drug development center in the world.

What will be the key benefits for the participants at the BioAsia’s clinical research conference?
Participants will have an excellent platform to interact with industry experts and policy-makers. They will also get a glimpse into how clinical research is viewed and conducted internationally. This will reinforce confidence in drug development in India.

 
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