Pakistan need to develop Academic Consortium at National, Regional and International level - Dr. Farhat Abbas


Clinical Trials Symposium at AKU

Pakistan need to develop Academic
Consortium at National, Regional and
International level - Dr. Farhat Abbas

Drug import for clinical trials should be made easier, Generation
of local data, ensuring GCP compliance, recognizing Sites for
clinical trials also needs to be looked into

KARACHI: The Clinical Trials Unit of Aga Khan University organized a two day symposium on Clinical Trials in Pakistan from February 20-21st 2014 which attracted researchers, representatives from the Pharma industry, Clinical Research Organizations, Government functionaries including DRAP representatives, some institution heads where adequate facilities for research and clinical trials are available besides a number of invited guest speakers from overseas. Bridging Gaps, Building Networks was the theme of the symposium. During the two days a number of important issues related to clinical trials like research ethics, cultural barriers, informed consent, importance and functioning of Ethics Committees, Institutional Review Boards, Patient Centered Trials, Challenges in Clinical Research, Gaps in clinical trials- the Pharma industry perspective, Human Resource Challenges, collaboration between different institutions, organizations at national and international level, developing hospital information system, generation of local data were discussed in detail by local and international speakers.
Summing up the deliberations in the concluding session, Dr. Farhat Abbas Dean of the Medical School at AKU said that we need to develop an academic consortium at national, regional and international level. Drugs import for clinical trial which have been approved and are also being used, should be made easy. Government should play an active role in monitoring and safety in the use of different molecules and we must generate local data. Other issues which need to be looked into include ensuring Good Clinical Practice (GCP) compliance, supportive role of the government while key institutions can also play a supportive role. Research Ethics, operational methodology, training and education was crucial wherein Aga Khan University can play its role. As regards funding sources, we need to ensure transparency and ensure that bias if any is removed. Yet another important issue is recognition of Sites Approval for undertaking clinical trials in different institutions. It is extremely important that all the stake holders work in synergy and come together to realize these objectives, he added.
This session was moderated by Mr. Iqbal Durrani Sindh Health Secretary who in his introductory remarks said that unfortunately the role of the government does not figure in this whole scenario. We do not have the proper infrastructure. On the other hand India has made lot of progress and a large number of clinical trials are conducted there and Clinical Trials registration is mandatory there. In Pakistan, we have done just about three hundred trials and we do not have a proper Clinical Trials Registry which is extremely important.
Participating in the panel discussion Dr. Patricia Hibberd from Harvard Medical School USA said that Clinical Trials are very complicated to conduct. You cannot predict what is going to be the outcome. We need to have people who know what to do when something happens while clinical trials are being conducted. She further stated that doctor’s start behaving like Physicians during the clinical trials saying change this and change that which is not possible as one cannot change the protocol once it is approved and finalized. Prof. Martin Stockler from University of Sydney Australia referred to the dangers for the participants in the clinical trails in view of the risky Adverse Drug Reactions. Evaluation of ADRs is important. We must realize that such ADRs are reported and happen thousands of times in clinical practice. The regulatory process is very complicated in Australia and time between clinical trials and actual availability of the drugs needs to be shortened by overcoming delays by the regulatory bodies. They should collaborate and work in partnership, he stated.
Mr. Shaukat Ali Jawaid Chief Editor Pulse International and founder member of National Bioethics Committee highlighted the problem of non-constitution of Provincial Ethics Committee in Sindh and in most of the medical institutions in the province and requested the Sindh Health Secretary to ensure that they are in place because these ECs/IRBs play a very vital role whether it is clinical trials, research or publications. Responding to this Mr. Iqbal Durrani said that the provincial government feels that after Health has become a provincial subject, there was no need of DRAP and other such bodies. Hence many such issues are pending. One of the representatives from the Pharma industry said that we need to educate the public and media about ADRs. There was no need to press the panic button un-necessarily but only in a situation if it warrants such an action. A representative from the CROs opined that we must recognize the limitations of Drug Regulatory Authority. Clinical Trials help the patients. Pharma industry is a highly regulatory industry globally and industry is bound to report ADRs, it does happen in clinical trials and it is part of the whole survey. Mr. Iqbal Durrani said that we lack Clinical Trials Registry in Pakistan and trial registration must be made mandatory.
Dr. Faisal Sultan Chief Executive of Shaukat Khanum Cancer Hospital from Lahore said that after 18th Constitutional amendments some things have become difficult. Provinces say that Health is a provincial subject. But we must understand that even in USA, while the different States are quite autonomous and know their Rights and Responsibilities; drug regulation is a federal subject which is looked after by FDA. Still for many years provinces will not have the expertise, human resources and other facilities to look at such issues. Hence we need to convince the law makers that defer implementation of some of these things for few years. Prof. Martin said that in Australia healthcare delivery is a provincial subject but drug regulatory affairs are handled by the federal government. Approval of any protocol by an Ethics Committee in one province is accepted by other provinces through a reciprocal procedure. Hence it is important that technical issues like drug regulations etc. should remain with the federal government.
Dr. Khawar Mehdi from Getz Pharma said that we all have gaps, be the academic, industry or the government. These gaps need to be bridged. We must ensure effective collaboration between different institutions. We must pool our resources and the government can offer some incentives, benefits, waivers to the Pharma industry to encourage research. Mr. Iqbal Durrani said that we must benefit from the collective wisdom and the industry should be provided some incentives to promote research. We can sit together and discuss these issues, he remarked. Bioequivalence studies, it was stated are essential and if some one was bypassing it, it was wrong. As regards availability of spurious and substandard drugs, it was related to Good Manufacturing Practices Dr. Irumnaz remarked. Dr. Rahat Qureshi highlighted the role of media which she opined was not yet clear and we must look into how they can be incorporated in this whole affair. Dr. Farhat Abbas remarked that after listening to Dr. Patricia, my perception about the clinical trials has changed completely. We have been informed that these clinical trials are highly governed, monitored and regulated practices and there was nothing to be worried about. However, we should have adequate participation of all the stake holders and try to earn the trust, confidence of the community assuring them that they were not being treated as Guiney Pigs in these clinical trials. A representative from one of the CROs asked whether clinical trials was considered as industry or an academic activity and treated as such and if there are so many problems, obstacles why they should bring clinical trials to Pakistan? At this Mr.Iqbal Durrani opined that it should be considered as an academic activity and not treated as an industry. However, Dr. Khawar Mehdi opined that CROs is called an industry all over the world. There are some ethical concerns. Government funding for research are decreasing and it is the Pharma industry which is replacing it. Mr. Lateef Sheikh Director Pharmacy Services at AKU remarked that the way clinical trials used to be conducted in Pakistan some years ago has changed a lot. In the past physicians were handed over some drug packets, they were asked to use it on their patients and give the report but no more. Now conducting of clinical trials require proper facilities, adequate monitoring, evaluation, taking care of safety and ethical issues etc. Now there are many partners in this journey. They should all collaborate and government should encourage them at which Mr.Iqbal Durrani assured that it will be forthcoming.
Mr. Firoze Rasul President of the AKU in his brief address said that knowledge comes from different sources. We must build on that knowledge for the betterment of the society to improve healthcare. Education of doctors and nurses was important and AKU continue to invest in this field.
In the end Dr. Azizunissa Irumnaz Director of Clinical Trials Unit at AKU who was the moving spirit behind this academic activity highlighted the journey of clinical research at AKU. Research, she said, was a part of the Charter of the University when it was established in 1983. In the early years it was Prof. Zulfikar Bhutta, Wasim Jafary, Saeed Sheikh and Amin Suria who did lot of useful research in 80s which was followed by Prof. Tariq Siddiqui, Saeed Hamid in 90s. Research office was established at AKU in 1999 and Clinical Trials office was housed there. In 2006 Clinical Trials Unit was conceived and its foundation stone was laid in 2009. It was in the Year 2011 that Clinical Trials Unit at AKU opened its door and now we have state of the art facilities for conducting clinical trials, networking and learning facilities. We are also working for Advocacy and Leadership besides developing infrastructure. We provide clinical trials management, lower trial cost, and fast endorsement with competency. We have made steady progress, hold workshops on GCP and writing of protocols. This has been an exciting journey, she added.
Mr. Lateef Sheikh presenting vote of thanks said that in challenges the geopolitical situation and certain other impediments were discussed and highlighted. All this can be managed if there is a will and we have the capacity, expertise to conduct clinical trials in Pakistan. Regulatory framework came under lot of discussion and criticism but with the functioning of DRAP, its consolidation, the situation will hopefully improve in the days to come. We do need to develop proper infrastructure. We have an excellent Clinical Trials Unit at AKU but we must move forward and create a critical mass for Pakistan so that clinical trials can be conducted at various institutions where facilities are available. Detailed report on some of the presentations during the two days symposium will be covered in the forthcoming issues.

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