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ISCR meet discusses clinical research challenges in India

ISCR's first annual conference had a very timely theme: leaping into the global arena. Manjusha Morgaonkar reports

Indian Society for Clinical Research's (ISCR) first annual conference, held from January 13 to 15, 2008, saw the active participation of clinical research professionals from all over the country, as well as key international speakers. Centred on the theme 'Clinical research in India—leaping into the global arena', speakers and delegates discussed various ways of raising the bar for clinical research in India.

In his keynote address, Utkarsh Palnitkar, Partner, Transaction Advisory Services, Ernst & Young spoke about the trends and future scenario of the clinical research industry in India. Palnitkar shared the findings of two surveys conducted by E&Y. He said that the number one trigger for relocating clinical trials to India was not cost savings, but the easy availability of subjects and the potential future market. The highest factor on the risk barometer was intellectual property and data confidentiality. Another trend visible from the E&Y survey was that auditors would proliferate and the best networked companies would win. The industry was moving from service and vendor led partnerships to strategic alliances and risk-reward sharing relationships.

In the clinical research and development session, Dr Venkateshwarulu, Drugs Controller General India (DCGI) spoke at length on 'Indian regulatory status and unfinished agenda'. Stating that the Indian clinical research industry was at the crossroads, he mentioned that the Government feels that there has to be a penalty for those not following rules. The DCGI said that there was a move to introduce a licensing system to regulate the clinical trials industry. Concerned about the mushrooming of fly-by-night operators who can damage the reputation of the industry, the Government is also looking at auditing studies. The audits will be followed by legislatures. The DCGI said guidances need to be drafted on paediatric and stem cell oriented clinical trials. He also touched upon the need to alter the way informed consents are recorded.

Commenting on the proliferation of clinical research education institutes, DCGI asked, "Are we making parrots in the name of clinical research?" These courses need to be accredited and there needs to be a minimum qualifications requirement for students entering these courses.

Answering questions on the possibility of allowing parallel phase I studies in India, the DCGI said that a proposal had been sent for clearance and was awaiting approval. "It will depend on our ability to convince politicians, media and the public at large that it is India's global responsibility to participate in global clinical trials if we are to benefit from global research," he concluded. To overcome the shortage of manpower, the DCGI's office is looking at contractual employment, and is also looking at volunteer independent reviewers, who will review matter sent for regulatory approval, after clearing conflict of interests. The regulator is looking at a three-tier system of review, counter-review and contest.

Dr Venkateshwarlu, DCGI releases the Conference Souvenir, as Suneela Thatte, ISCR Ethics council, Dr CN Potkar, ISCR Media/Events council, Utkarsh Palnitkar, Partner, Transaction Advisory Services, E&Y, Dr Suresh Menon, President, ISCR and Dr Arun Bhatt, ISCR Training council look on

The DCGI's talk was followed by the global regulatory perspective by David Verbraska Executive Director, Global Head, Worldwide Regulatory Policy and Intelligence (WRPI), Pfizer. Speaking on 'Emerging global regulatory challenges', Verbraska outlined the recent developments in Europe and the US. The third speaker in this session was Dr Milind Antani, Head-Pharma, Life Science and Healthcare Practice Group, Nishith Desai Associates, who spoke on 'Stakeholder liability in clinical research'. Other sessions of the day included data management and statistics, patient and media perceptions.

The sessions of second day of the conference focused on the ethical challenges faced by the clinical research community. The first session of the day two conference was chaired by Dr VR Joshi, Director of Research, P D Hinduja National Hospital and Dr Nithya Gogtay, Assistant professor, Clinical Pharmacology, GS Medical. Dr Sangeeta Desai, Professor, Department of Histopathology, Tata Memorial Hospital addressed the first session on 'Improving quality of ethics committee performance'. This included a prolonged discussion on problems faced by IRB members, administrator and support staff, like education, training, quality assurance, performance measures etc, and also the solutions for these problems.

The second speaker for the session Dr Peush Sahani, additional professor, Department of Gastro-intestinal Surgery, All India Institute of Medical Sciences (AIIMS), discussed the 'Informed consent process—the Indian challenge.' Speaking about the problems faced by the deprived masses during trials due to illiteracy, Sahani said, "I hope we overcome the problems faced by the rural masses. But for now, clinical research will continue to be in India with great prospects thanks to the booming investments in this industry." Dr Vasanta Muthuswamy, Senior Deputy Director General and Chief, Division of Basic Medical Sciences, Indian Council for Medical Research (ICMR) spoke on 'Capacity building in research ethics'. Muthuswamy added that bioethics education and training workshops should be introduced for students.

The fifth session was chaired by Dr Sapatnekar, Dean, Clinical Research Institute (India) and Dr Vasudeo Ginde, Managing Director, iGate Clinical Research International. Discussing the 'War for talent', Ginde said that "passion, attitude, intelligence, multitasking, integrity and commitment constitute talent which means talent is not about qualification but about attitude." Speaking about the 'Global quality expectations' in clinical research, Trond Tennoe, Regional Operations Director and Senior Director, PGRD, Pfizer, pointed out that quality, cost and speed can bring new drugs easily to the global market. "I think India will grow in clinical research in future. If India attains the above mentioned characteristics, then the country's future will outshine in clinical trial. Our major role in introducing clinical trials will be to introduce drugs and bring it to India and also in other countries," she said.

The sixth session was chaired by Dr Shoibal Mukherjee, Vice President, Medical Affairs and Clinical Research, Ranbaxy and Dr Vinod Raina, head, Department of Medical Oncology, AIIMS. Dr Neelima Kshirsagar, Emritus Professor, Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital spoke on 'Methods in pharmacoepidemiology and drug safety' that included pharmacovigilance in India, issues on ADR, global aims and methods in pharmacovigilance for safety assessment and current scenario in medication.

The conference closed after a panel discussion focused on broader issues like EDC implementation in India, data management track, standards, regulatory and legal challenges in clinical trials, DCGI investigation, changes in regulation, legal implication in clinical research, collaboration between capacity building, and training for students. Dr Veena Jaguste, Director, Development Operations Amgen, said that media should be deemed as a tool for education and not for publicity. As she put it "Unlike Bollywood or cricket, we cannot be in the news, so we should make optimum use of it."

Response to the conference was very positive from all stakeholders. Applauding ISCR's efforts to put together such a "scientific feast", Vijay Moza, Managing Director, Clinical Research Institute (India), said, "ISCR should take steps to prepare a consensus document for benchmarks that will primarily fulfil the need of CR Industry and set professional standards for academic institutes. We need to be concerned on quality and contents of the curricula of clinical research diplomas/certificates. There is a need to decide the minimum standards to initiate training institute in clinical research. The consensus document should be periodically revised."

Dr Anjali Singh, Chief of Lab-Clinical Research, Dr Lal PathLabs said that conference was much more than expected while Venkatraman Sunder, Head of Asian Clinical Trials, commented that the conference gave in depth coverage on clinical research and expectations of the future of Pharma and CRO industry in India. Dr H P Tipnis, Director, Pharmacy, Medicine Shoppee said that many new ideas emerged, thanks to the good speakers at the conference.

manjusha.morgaonkar@expressindia.com