Benchmarks

The CROs are following the guidelines set by the ICMR on ethical issues and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (in short ICH) - Good Clinical Practice (GCP) guidelines while conducting the trials. Brijesh Regal noted that the Indian GCP guidelines are in sync with the ICH guidelines.

The GCP is a standard for clinical studies in design, conduct, monitoring, termination, audit, analysis, reporting and documentation. It is a scientific and ethically sound and well documented process. The study should be implemented and reported in such way that the data is credible, accurate and the rights, integrity and confidentiality of the participants should be protected. "There are specific guidelines in India for conducting of clinical trials. In addition to that we have a rapid scrutiny of clinical trial applications and different departments of the government like ministry of health, DCGI, ICMR and Department of Biotechnology are working in tandem to promote clinical research. Still I don't understand the role of Genetically Engineering Approval Committee (GEAC - a division of the ministry of environment and forests) in the clinical trials," noted Dr Ramananda S Nadig, of Eli Lilly.

There are many regulatory agencies under DCGI like ICMR (vaccines), NIB (biologicals), GEAC-DBT (genetically modified drugs), DGFT (export/import) and CRI/CDTL (drug testing). It will take approximately 16 months – 36 months from application filing to launching a drug in the market. This is due to many problems like lack of trained people, infrastructure, resources etc. The delay in the process of approval after filing the application with the regulatory agencies and the absence of clear guidelines from these agencies are putting enormous pressure on drug development companies.

This scenario has resulted in the emergence of self-styled researchers to take advantage of the situation by conducting unethical/illegal trials at private clinics without the fear of regulatory authorities as they fail to take action against such mischief makers in the society. In such cases the patients are left with no avenue for seeking compensation for any mishaps involving the trial drugs. Such cases are covered only by the non-statutory Ethical Guidelines for Biomedical Research on Human Subjects of Indian Council of Medical Research (ICMR)- 2000. Sponsors are now looking at insurance companies to cover the people working in clinical trial projects and also to protect the interest of the patients. The insurance companies are also coming forward to support the upcoming industry.

Agreeing with this point, Dr Vasantha Muthuswamy, senior deputy director-general, ICMR said, "so far no one has been prosecuted for such misdeeds." She also noted that not only in India even in US there are violations related to clinical trials.

There is a general decline on the ethical conduct across the professions. The need of the hour is for a legislation related to research and ethical guidelines and enactment of these guidelines, she said.

This was mainly because of lack of infrastructure/resources with the implementing agencies. To overcome these the government is expected to present The Biomedical Research on Human Subjects (Regulation, Control and Safeguards) Bill 2004 in the winter session of Parliament.

Latin America

Latin America had first regulatory inspection in 1976 30 years of clinical trial experience Major growth in last 10 years Local affiliates and International Companies Major Companies have 12 year history of organising training events LA DIA and similar conferences will attended Data now fully acceptable Data accepted for pivotal phase III studies Rescue and included in initial study design (50:50) High level of sites meet recruitment targets Source: Kendle International

Eastern Europe
GCP Trials started in the early 1990s Increasing in numbers performed First FDA Inspections: Poland - 1994 Russia - 1995 Czech Republic, Hungary, Slovenia, Romania - 1998 Croatia – 2000 Slovenia, Hungary, Romania 1993 Growing elderly population Source: Kendle International

Dr Sonal Vora urged like-minded industry people to come together to form an association/group that can work as a consortium to resolve many issues facing the sector. Endorsing the same views, Dr Anupama Ramkumar of Lambda Therapeutic Research observed that the sector should be organized like Nasscom to bridge the gap between the industry and government.

Considering these Michael S Brown, a Nobel Laureate, 1985 has rightly said 'in great issues of medicine in the twenty first century', " The physicians should be telling the drug companies what drugs to develop, not the other way around. You have heard that war is too important to be left to the generals: likewise drug development is too important to be left to the drug companies. We need creative physicians at the beginning to help design drugs and to figure out how best to use them."

Activities galore

There is an increase in the CRO presence, expansion of training facilities, more collaborative activity around the clinical research and greater regulatory attention. At the same time they should look at some of the issues, which will come in their path of growth like regulations, documentation, ethics, inspections, training, patients safety etc.

The CROs should keep themselves updated about the latest happenings and collectively share the best practices and abide by the ethical code of conduct. They should also look for strong partnership with academia for trained people. They also have to take into confidence of the non-governmental organizations working for the betterment of poor people by involving them in different activities like awareness programs on clinical research or campaigns. The CROs should also look at entering local as well as global partnership/alliances. Partnerships make a difference when it comes to return on investments and it will result in reduced cost and time in bringing the drug to the market.

The CROs should look at networking components like hospitals/ healthcare centers, medical colleges and institutes, R&D facilities, universities and colleges in addition to looking at partnerships. This networking will help them in reaping more
benefits.

Narayan Kulkarni in Mumbai and N Suresh in Bangalore

"There are no clear rules on drugs discovered by Indian companies abroad, drugs discovered abroad but licensed to an Indian company, drug discovered by an Indian subsidiary of foreign company. These are blocking the researchers to take up the Phase I clinical trials in India, " Shoibal Mukherjee, senior director, medical and research division, Pfizer Ltd.

"Data privacy is a key and major issue before the CROs. It is unlikely to go away with just guidelines/regulations. The revamped IPR system in the post- January 2005 period will smoothen the process to some extent," Dr Ramananda S Nadig, medical director, Eli Lilly and Company (India) Pvt Ltd.

"The electronic-savvy clinical research sector in India is moving fast with the usage of the computers," Dr Ferzaan Engineer, CEO, Quintiles Research India Pvt Ltd.

"There are many people working on the projects at different sites and stages. Possibilities are there that information may be leaked at the sponsor's place due to many internal problems in the organization. It may be leaked at CROs or at the investigator's level," Dr Swashraya Shah, medical director, Astra Zeneca Pharma India Ltd.