Majority of Clinical Trials are currently being conducted in China,
USA, Japan, South Korea and Brazil Pakistan needs to establish
Biotechnology Plant as so far we have failed to start production
of cloned pharmaceutical proteins-Prof. Javed Akram
LAHORE: Peoples Republic of China is making tremendous progress in every field including Research publications and Clinical Trials. At present maximum number of research papers are being published from United States and China and by the Year 2025, it is expected that China will emerge as the world leader in the field of Research and Clinical Trials. Other countries which are giving too much importance to clinical trials and are performing these studies apart from USA and China include Japan, South Korea and Brazil while India has also made lot of progress.
Prof. Ahsan Waheed Rathore VC UHS alongwith Mr. Shaukat Ali Jawaid
Advisor CME Courses at UHS presenting a Memento to Prof. Javed Akram President PSIM and former VC UHS. He was one of the facilitators for
the CMEJ course and discussed Clinical Trials.
This was stated by Prof. Javed Akram, President of Pakistan Society of Internal Medicine(PSIM) and former Vice Chancellor of University of Health Sciences. He was making a presentation at the Certificate in Medical Editing and Journalism (CMEJ) which is a joint project of University of Health Sciences and Pakistan Association of Medical Editors (PAME) at the UHS campus on March 1st 2024 during the first contact session of CMEJ. During his presentation he gave an overview of clinical trials, introduction to various trial registries, salient features of ICH-GCP Guidelines besides Regulatory Pathways for clinical trial registration and clinical research.
He further pointed out that our religion also says that to learn, one should go to China and the time has proved it right. In the days to come Insulin for the treatment of Type-II Diabetes will become obsolete as now oral medications are being developed. It is because of clinical trials that twenty-five vaccines, five thousand five hundred biological products, thirteen thousand one hundred seventeen human drugs, twenty-five thousand nine hundred one medical devices have been developed. Many world renowned pharmaceutical companies have now shifted their Research & Development departments to China. It is pharma industry which is sponsoring most of the drug research. Unfortunately, in Pakistan the academicians and universities have so far been shy in collaborating with the pharma trade and industry which is a major source of funding with the result that our clinical trials are not being translated into good research publications.
During COVID19, over three hundred healthcare professionals died in Pakistan. It was then that we initiated Phase-I to Phase-IV trials. We conducted trial on Chinese Covid Vaccine, published its protocol and now the full paper is under publication in Pakistan Journal of Medial Sciences. We also undertook VICTORI trial. Vitamin-D, he said, is extremely important for many body functions. Studies have showed that 79% of Pakistanis were deficient of Vitamin-D and 25% of them had severe deficiency. Hence we decided to stop testing for Vitamin-D deficiency and started using a dose of two hundred thousand units of Vitamin-D during Covid in Intensive Care Units with good results. We desperately need to establish Biotechnology Plants.
In case of burns, Patients with 50% burns, only 5% of them survive. They need to be covered with artificial skin. Euroderm is very expensive. We produced PakDerm which was used in one hundred thirteen patients at Jinnah Central Hospital which proved it was as effective as EuroDerm. We could not start bulk production since we do not have any biotechnology plant and setting up such a plant requires lot of investment. We did approached numerous leading national and multinational pharmaceutical firms but none of them has come forward and showed interest in establishing a biotechnology plant. We have cloned twenty-seven pharmaceutical proteins but could not start commercial production due to lack of biotechnology plant.
Giving details of clinical trials, Prof. Javed Akram said that Phase-I trials are conducted in few patients to check safety. Phase-II trials are done in more patients to check its efficacy and dose. In Phase-III trials the long term safety and efficacy of the drugs are tested while in Phase-IV post marketing surveillance are performed. In Pakistan most of the studies are Phase-IV which are being conducted. At times some off label drugs are also used particularly those which have anti-cancer properties. He also disclosed that when they started conducting these studies at UHS they had to face lot of hurdles, He personally received many nasty letters from the government authorities asking me to give explanation as to why I was involved in Research but must concentrate on teaching, training and examinations. I responded with a strong worded letter telling them that the prime objective of the universities was to produce knowledge which is only possible if they are involved in research and clinical trials.
It is generally observed that 85% of clinical trials fail to retain patients, 80% do not finish on time, 50% of Trial sites do not attract patients. In case the trial is investigator sponsored, the rights of data are with the investigator but in case of industry sponsored trials, they have the right over data and in case of negative results, they may not like to publish it. He laid emphasis on ensuring integrity in research. It is important that researchers uphold professional ethics, get proper approval from Ethics Committees and Institutional Review Board for the proposed studies, ensure informed consent of the patients who must be told about the likely adverse effects, they should have the right to withdraw from the trial at any stage and they must be properly treated of any adverse effects. It is also important to maintain confidentiality. All ongoing trials should prepare annual reports as per local rules and regulations.
Audit and transparency is very important for clinical trials. It is well established that mortality is very high for Acute Myocardial Infarction and Stroke in the early morning hours. The trials can be stopped before time if the results are very good or some serious adverse effects some of which could be life threatening are noted. During Covid19 we noted that those patients who were on regular low dose Aspirin or who were put on Aspiring therapy in addition to other drugs, there was 27% reduction in patients going on ventilators. We use various combinations of drugs and patients who got most of the drugs fared much better. For this trial we had selected potential trial sites which were all inspected and regular monitoring was ensured.
All those who registered for the trial were closely followed up for any untoward side effects. They were also offered some financial incentives to participated in the study. Proper monitoring of the trial and compliance by the patients is extremely important. Now we do have some Clinical Research Organizations (CROs) who provide all these services but the number of CROs functioning in India runs in hundreds and it also brings lot of foreign exchange to the respective countries. We have the talent and if we can ensure proper training, accreditation of investigators and Trial sites, we too can earn lot of precious foreign exchange, he concluded.
Earlier Mr. Shaukat Ali Jawaid welcomed Prof. Javed Akram and pointed out that it was due to his sincere efforts as Vice Chancellor of University of Health Sciences that we could start this Certificate Course in Medical Editing. He thanked him for his vision and foresight in promoting the discipline of Medical Journalism in Pakistan. Later Prof. Ahsan Waheed Rathore Vice Chancellor of UHS presented him a Memento in recognition of his contributions to this academic activity.
