The workshop was an extension of the recently held Health Asia Congress 2006 and was organized by Smart Health Care—a subsidiary of Ecommerce Gateway Pakistan in collaboration with Metrics Research, the first multinational CRO of Pakistan, Kriger Research Group International, Canada and Macter International Private Limited, Pakistan.

The speakers at the workshop urged upon the clinical researchers in Pakistan to gain knowledge of GCP concepts and principles, as it was customary for them to get their research papers published in international journals. They also stressed upon the need to sensitize the health sector—both public and private—for setting up clinical research facilities in the country and to encourage medical and science graduates to opt for a career as clinical researchers.

Speakers and trainers at the workshop included Dr Pedro Lopez Saura, Director, Centre for Genetic Engineering and Biotechnology, Cuba, who is on an extensive visit to Pakistan to evaluate clinical trials on Hepatitis-B vaccines and Hepatitis-C interferon produced by his center, and to liaise with leading healthcare institutions of the country. The clinical trials are being carried out in collaboration with Macter International in Karachi, Lahore, Islamabad and Peshawer.

Dr Mustafa Kamal, Chairman, Department of Biotechnology, University of Karachi; Dr Zakiuddin Ahmed, Medical Director, Macter International Private Limited; Khurram Zaki Khan, Chief Executive, Metrics Research, Dr Qasim Iftikhar, Associate Director, European Medical Affairs, Chiron (Novartis) Biopharmaceutical Europe; Faisal H. Roohi, Regional Manager, Kriger Research Group Canada; Dr Asghar Naqvi, Medical Director, Pfizer; Dr Syed Tajamul Hussain, General Manager Medical Services and Regulatory Affairs, Merck; and Iqbal Mujtaba delivered their presentations to educate and train the participants about the various aspects of Good Clinical Practices.

Dr Mustafa Kamal during his presentation titled "How do drugs come into market?" elaborated upon the various stages of drug discovery and development. Dr Kamal informed that the highly sophisticated process of identifying a molecule carrying medicinal properties and developing it into a marketable drug may take around 10 to 12 years and a budget of several million dollars. On an average 10,000 different molecules are screened initially, out of which 250 enter the pre-clinical testing phase carried out on animals subsequently allowing five molecules to reach the clinical trial testing requiring human volunteers and only one of which is approved by the drug regulatory authorities.

Dr Zakiuddin Ahmed, Medical Director, Macter International Private Limited delivered a presentation on the "Role of a Clinical Research Associate". He said that in order to opt for a career as a CRA one should have a degree in life sciences such as pharmacology, pharmacy,
biochemistry, biotechnology, physiology, microbiology, etc. The typical work activities of a CRA, he explained, include identifying and briefing the suitable doctors or consultants as investigators to conduct the trial; setting up study centers, ensuring each center has the trial materials and checking that the investigator knows exactly what has to be done; monitoring the trial throughout its duration which involves checking the patient data in the case report forms (CRFs) and sort out any problems which may arise; validating and collecting CRFs; discussing results with the statisticians, etc.

In his presentation on "Understanding the basic need for GCP", Dr Asghar Naqvi said that the term Good Clinical Practices was a misnomer and was a widely misunderstood concept in Pakistan. He was of the view that it should be re-phrased as Good Clinical Research Practices. He explained that GCP was a quality standard for the design, conduct, performance, monitoring, auditing, recording, analyzing and reporting of clinical trials that provide assurance that the data and reported results were credible and accurate and that the rights, integrity and confidentiality of the subjects were protected.

Dr Naqvi gave an overview of the evolution of GCP mentioning its different milestones such as the Thalidomide disaster (birth defects) in 1961 when thousands of congenitally deformed infants were born as a result of exposure in utero to an unsafe medicine promoted for use by pregnant mothers. The disaster resulted in the 16th World Health Assembly (1963) adopting a resolution that later led to the creation of WHO Pilot Research Project for International Drug Monitoring in
1968.

Dr Syed Tajamul Hussain elaborated upon the issues of GCP compliance for clinical research and highlighted the ethical protocols required for the same.

Around 40 senior consultants and physicians from various medical institutions attended the workshop that will be certified by Kriger Research Centre, Canada.