KARACHI: Pakistan lags behind in clinical research
KARACHI, Sept 9: Experts at a two-day workshop on Good Clinical Practices (GCP) and Biostatistics, that concluded here on Saturday, urged clinical researchers in Pakistan to gain knowledge of the GCP concepts and principles as it was customary for them to get their research papers published in international journals.
The workshop at Liaquat National Hospital was an extension of the recently held Health Asia Congress 2006.
The speakers informed that at present clinical research was a $60 billion industry globally and realising its potential the Indian health sector had heavily invested in this area attracting an annual business of more than $300 million from other countries.On the contrary, the number of clinical researchers in Pakistan was alarmingly low and one could not even find a WHO-approved lab facility where bioequivalence and bioavailability studies and research on drugs could be carried out.
Speakers and trainers at the workshop included Dr Pedro Lopez Saura, Director, Center 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 centre and to liaise with leading healthcare institutions of the country. Dr Saura's session during the workshop included a presentation titled “Statistical principles applied in clinical trials”.
The chairman of the Department of Biotechnology, University of Karachi, Dr Mustafa Kamal, in his presentation titled “How do drugs come into market?” elaborated upon the various stages of drug discovery.
Dr Kamal informed that a 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, he informed.
Dr Zakiuddin Ahmed gave 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, included identifying and briefing doctors or consultants as investigators to conduct trials; setting up study centres, ensuring each centre had the trial materials and checking that the investigator knew exactly what had to be done; monitoring the trial throughout its duration which involved 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 a widely misunderstood concept in Pakistan. He was of the view that it should be rephrased 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 provided assurance that the data and reported results were credible and accurate and that the rights, integrity and confidentiality of the subjects were protected.
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 attended the workshop.—PPI
