PakMediNet Discussion Forum : Medical Research in Pakistan : Multi-National Clinical Trials
Multi-National Clinical Trials
Salaam,
I work for a clinical research organisation in the UK and am responsible for expanding our clinical research activities to India and Pakistan. Most of you will already be aware that extensive research is being undertaken in India but we are exploring newer areas such as Pakistan.
Being a Pakistani myself I have a special interest in performing these studies there. However, I don't really have much idea of how clinical research is really conducted. What is the regulatory process? Do the major research hospitals/institutions have ethics committees? Are doctors aware of ICH-GCP / Declaration of Helsinki? Are there clinical research associates or monitors?
I hope you don't think i am being condescending/patronising but I just don't know - please forgive me ignorance - I just want simple, honest guidance.
Thank you for all your comments.
Yamin
Posted by: ymkhan Posts: 4 :: 20-08-2002 :: | Reply to this Message
Re: Multi-National Clinical Trials
ymkhan!
We here in Pakistan, unfortunately not a good architecture for biomedical research in our hospitals (Govt ones). Doctors and health professionals have little knowledge and interest in such activities. This is due to low salary, over burden of work and poor guidance. However, CPSP has played a good role in writing a research dissertation for every candidate who has to qualify for FCPS. Therefore, this practice has made some awareness and attitude towards research.
Basic biomedical research in Pakistan is almost negligeble. However, there are some areas which are doing basic research but since it is less projected and funded, little people know about it.
PakMediNet is formed with the aim to promote biomedical research in Pakistan. We are doing our best to project this aspect of Pakistan, but we still have long way to go to achieve something better.
Posted by: docosama Posts: 333 :: 21-08-2002 :: | Reply to this Message
Re: Multi-National Clinical Trials
Ymkhan, AOA
It was nice to see a Pakistani working abroad and having concerns about his country. Research in pakistan is very difficult and unsponsered and uncontrolled.However now some activity is going on. Thanks to CPSP. Various randomised controlled trials worlwide are now encouraging pakistani researchers to participate in these trials. We recently participated in Magpie trial{ along with collaborators from Islamabad and karachi}and are now continuing its followup phase. BUT MAJOR PROBLEMS FACED BY US WERE ETHICAL COMMITTEE APROVAL,CUSTOM'S CLEARANCE, NOC FROM DRUG INSPECTORS, LACK OF FAX ,INTERNET FACILTIES WITHIN HOSPITAL PREMISIS ETC.
I think majority of our doctors are unaware of the ongoing research work worldwide. If we can communicate to them the recent reserach activities and recruiting trials,it will help in adding pakistani data to the international data.
Also we need to establish local research and ethical committes at hospital/institution level.
What next we can provide is to help the young researchers in getting statistical guidance right from inception to completion of research. Majority of doctors are not aware how and from where to get help in study design, data collection and statistical analysis.WHAT WE NEED IS RESEARCH AND STATISTICAL PROMOTION SOCIETIES,AND PAKMEDINET IS THE BEST FORUM FOR ITS INITIATION>
Posted by: lachvi Posts: 47 :: 21-08-2002 :: | Reply to this Message
Re: Multi-National Clinical Trials
Thank you for your responses.
So far two issues have been highlighted:
1 - Lack of experience of investigators (doctors) in clinical research
2 - Logisitic issues
Point 1 is not a problem. The type of trials I am talking about are those that are sponsored by big Pharam companies (Pfizer, Novartis, GSK). The investigators are supplied with a written protocol (inc. all biostats) and all the investigators need to do is to select patients that fulfil the protocol criteria and then perform the procedures specified in the protocol. The training on the protocol will be provided by the sponsor. However, the investigators will need to be trained on ICH-GCP.
2. Second issue may take longer but are there no organisations in Pakistan trying to promote clinical trails apart from PakMedi Net - any government-affiliated bodies trying to promote trials and improve the efficinecy of customs etc.
An article was printed in a UK journal (written by Wyeth, Pakistan) on performing clinical trials. It stated that certain Pakistani hospitals had GCP-trained doctors, ethics committees and the regulatroy processes in place to perform these studies - is this not true?
Finally, I am plannig to visit Pakistan (Islamabad) for 2 weeks starting from 21 Sep - is it possible to meet people to talk about clinical trails - maybe PakMediNet and/or leading researchers in hospitals (based in Islamabd).
Thank you for your continuous help.
Regards.
Yamin
I think the problem is with Although I understand the logisitic difficulties in getting these traisl set-up in Pakistan
Posted by: ymkhan Posts: 4 :: 23-08-2002 :: | Reply to this Message
Re: Multi-National Clinical Trials
ymkhan:
Sir, PakMediNet is a non funded voluntary effort started 1 year back. Aims of its creation as you have stated are to promote biomedical research of Pakistan. Idea is to include all researches that were or are going in Pakistan. However, due to unavailability of funds and support, work on PakMediNet is slow and will take a lot of time.
There are currently 33 online journals available, still 5-6 to go. Issues of included journals are not completed yet due to lack of voluntary support. Idea was to include all previous issues of all journals but big problem is that most of the journal editors themselves do not have the issues. So, i am in continued search to locate previous issues and include them on the website.
2ndly, next phase is to include published public health surveys, researches done by various Govt and non-govt organizations in Pakistan. This also is indeed a hard job.
I am soon going to add "Pakistan Health Survey 1996" under the Research in Pakistan area of PakMediNet. This section will be expanded later on.
If you are willing to cooperate, then we'll meet you in Pakistan and discuss the future issues and ideas.
Posted by: docosama Posts: 333 :: 23-08-2002 :: | Reply to this Message
Re: Re: Multi-National Clinical Trials
Dear dr Osama,
I am very impressed by the hard work done by you and your colleagues. If you can mention the missing issue's details at the website may be some of the raeders like me will donate the issues if they have.
Also to enquire about the journals published from Peshawar. There are two journals presently published from Peshawar
1) JPMI journal of postgraduate medical institute { Hayat abad Medical complex/ Lady Reading Hospital Peshawar }
2) JMS " Journal Of Medical Sciences" published from Khyber Medical college Peshawar,
If you would like to include these journals in your list for the display on website I may be able help you in this regard
Thanks
Dr Akhtar Sherin Lachvi
quote:
docosama wrote:
ymkhan:
Sir, PakMediNet is a non funded voluntary effort started 1 year back. Aims of its creation as you have stated are to promote biomedical research of Pakistan. Idea is to include all researches that were or are going in Pakistan. However, due to unavailability of funds and support, work on PakMediNet is slow and will take a lot of time.
There are currently 33 online journals available, still 5-6 to go. Issues of included journals are not completed yet due to lack of voluntary support. Idea was to include all previous issues of all journals but big problem is that most of the journal editors themselves do not have the issues. So, i am in continued search to locate previous issues and include them on the website.
2ndly, next phase is to include published public health surveys, researches done by various Govt and non-govt organizations in Pakistan. This also is indeed a hard job.
I am soon going to add "Pakistan Health Survey 1996" under the Research in Pakistan area of PakMediNet. This section will be expanded later on.
If you are willing to cooperate, then we'll meet you in Pakistan and discuss the future issues and ideas.
Posted by: lachvi Posts: 47 :: 27-08-2002 :: | Reply to this Message
Re: Multi-National Clinical Trials
Dr. Akhtar
It would be excellent if you arrange these 2 journals for PakMediNet. Unfortunately, both of them have not replied to the mails we have sent them.
Thank you for your encouragement.
Posted by: docosama Posts: 333 :: 27-08-2002 :: | Reply to this Message
Re: Multi-National Clinical Trials
Dear Dr. Y.M.Khan,
There is no problems in conducting any type of research including clinical trial in Pakistan. You will get everything here.
In case you face any difficulty, you can contact me.You can email me and get my contact numbers. All services will be complimentary.
Posted by: nrehan Posts: 6 :: 30-08-2002 :: | Reply to this Message
Re: Re: Multi-National Clinical Trials
Dear Osama,
to whom and how should I send the journals. Whatever in record is available will be sent to you.
Akhtar Sherin
quote:
docosama wrote:
Dr. Akhtar
It would be excellent if you arrange these 2 journals for PakMediNet. Unfortunately, both of them have not replied to the mails we have sent them.
Thank you for your encouragement.
Posted by: lachvi Posts: 47 :: 04-09-2002 :: | Reply to this Message
Re: Multi-National Clinical Trials
If you have talked to the editors of the journals then please send us the issues at the address: 30 Westrige 1, Rawalpindi Phone: 5475907
I do not put journals on PakMediNet without permission from the Editors.
Posted by: docosama Posts: 333 :: 05-09-2002 :: | Reply to this Message
Re: Re: Multi-National Clinical Trials
Thanks for the information. I have already discussed it with the editor oF JPMI but yet to discuss with the editor of JMS.
soon you will get the copies of JPMI.
Thanks
akhtar
quote:
docosama wrote:
If you have talked to the editors of the journals then please send us the issues at the address: 30 Westrige 1, Rawalpindi Phone: 5475907
I do not put journals on PakMediNet without permission from the Editors.
Posted by: lachvi Posts: 47 :: 06-09-2002 :: | Reply to this Message
Re: Multi-National Clinical Trials
Dear Sir,
I am associated with a mutinational pharmaceutical organization and have the project management responsibility regarding local & multinational clinical trials. With this discussion forum, I feel pleasure in having this opportunity to enlighten our readers with the following information: Atleast five of the leading hospitals in Lahore, three in Karachi, four in Rawalpindi & three in Peshawar have Medical Ethics Committees (or IRBs/IECs). I have first hand knowledge of at least more than half a dozen Phase III-B/Phase-IV and about a dozen and a half Phase-II & III multinational clinical trials sponsored by my company whose trial centres were also established here & which excellently contributed to the trials with fast & large patient recruitment as compared to other countries in the region. This involves all the essential steps which are required like: investigator & site screening & selection, IRB approval, Health Authority approval & import license approval (in case study drugs are to be imported), investigator meetings (involving investigator & research team ICH-GCP guidelines training & protocol and CRF discussion etc), site-initiation meetings, monitoring, pharmacovigilance, data-forwarding & data-query resolution, site closure & data-archiving etc etc.
Apart from this, I am also aware that other mutinational pharmaceuticals are also involved in the conduct of multinational trials here in Pakistan.
Nearly a decade ago, clinical research was indeed a big 'no no' for most of us, but thanks to the training & clinical resources being provided by a number of multinational pharmaceuticals in this regard, it has unleashed a great number of great clinical investigators here in our country who are furnishing quality patient data to these trials.
Infact, mine & other organizations are currently liaising with our health authorities to standardize & harmonize the research process & its requirements throughout the country to legally ensure compliance to local regulatory & ICH-GCP, to overcome the problems that sometimes occur due to the non-availability of country-wide applicable rules for this, which had to be dealt with individual efforts.
In the end I would like to state that with the huge patient pool involving diseases of all systems available here and vast talent of qualified doctors & postgraduate residents who can prove to be excellent investigators when adequately trained (and many of them 'are' now), all organizations including pharmaceuticals & CROs should be encouraged to further explore this area. I myself will be pleased to furnish with any more information to help achieve this objective.
Kind regards.
Posted by: Dr. Javed Posts: 3 :: 13-01-2003 :: | Reply to this Message
Re: Multi-National Clinical TrialsI wanted to know which clinical trials are sponsored by your company ? Are they related to internal medicine or not ? Are these trials are the part of some foreign clinical trial or they are generated from your self work ?
Posted by: docosama Posts: 333 :: 15-01-2003 :: | Reply to this Message
Re: Multi-National Clinical Trials
quote:
ymkhan wrote:
Salaam,
I work for a clinical research organisation in the UK and am responsible for expanding our clinical research activities to India and Pakistan. Most of you will already be aware that extensive research is being undertaken in India but we are exploring newer areas such as Pakistan.
Being a Pakistani myself I have a special interest in performing these studies there. However, I don't really have much idea of how clinical research is really conducted. What is the regulatory process? Do the major research hospitals/institutions have ethics committees? Are doctors aware of ICH-GCP / Declaration of Helsinki? Are there clinical research associates or monitors?
I hope you don't think i am being condescending/patronising but I just don't know - please forgive me ignorance - I just want simple, honest guidance.
Thank you for all your comments.
Yamin
Posted by: syeduzair Posts: 3 :: 24-09-2003 :: | Reply to this Message
Re: Multi-National Clinical TrialsCan you please describe about the company are talking about ? Users will be interested in that.
Posted by: docosama Posts: 333 :: 24-09-2003 :: | Reply to this Message
Re: Multi-National Clinical Trials
Assalam ALaikum
I am pakistani medical graduate , currently working in USA as a Resident PGY2 in internal medicine. Before joining this program i spent almost 2 years in medical research. I was involved in number of projects funded by NIH. Some of these projects were multi center and held at most notable institutions in USA naming a few such as, Mt Sinia medical center, Columbia University, Newark beth israel, University of california, UNiversity of oklahoma, Pennstate university PA, Temple university PA. Our most recent study ( Heart Allograft Rejection detection by Alkanes in Low levels) was very successful and was published in Journal of American college of cardiology. NOw this study is going to be published in more details in journal of Heart and Lung transplant.FDA recently approved this test for the survellance of cardian transplant patient. We were doing an other study to analyze the correlation between malaria and Oxidative strees. At the beginning i propsed to start this study in Pakistan which was accepted by the principal investigator. I attempted to contact my medical college in lahore and explained that money would go to the college plus the name of the college will be published in the international medical journals. BUT you know what happened ----- no one paid no mind to my offer and that study slipped to papua new guinee. I was upset for months for this loss.
Working here i developed good know how of how to conduct the research, i really want to utilize my experiance to do something in my own country , however i cant do this alone, i need toehrs to be part of it. We need to work at gross root level to educate our medical studants. THese young doctors are the ones who if trained well, will become research scientist to earn a good name for the country.But its so upsetting that in medical colleges studants are not provided enough guidance to do somehting. Professors are busy to make money in their private clinics and young doctors are striving to make the ends meet. This system is not allowing us to add something new to the field of medicine.
We have to work on self help basis as its useless to wait for the Govt. to start some project. Lets think about this.
Regards
Taseer Cheema, MD
quote:
ymkhan wrote:
Salaam,
I work for a clinical research organisation in the UK and am responsible for expanding our clinical research activities to India and Pakistan. Most of you will already be aware that extensive research is being undertaken in India but we are exploring newer areas such as Pakistan.
Being a Pakistani myself I have a special interest in performing these studies there. However, I don't really have much idea of how clinical research is really conducted. What is the regulatory process? Do the major research hospitals/institutions have ethics committees? Are doctors aware of ICH-GCP / Declaration of Helsinki? Are there clinical research associates or monitors?
I hope you don't think i am being condescending/patronising but I just don't know - please forgive me ignorance - I just want simple, honest guidance.
Thank you for all your comments.
Yamin
Posted by: drcheema Posts: 4 :: 28-09-2003 :: | Reply to this Message
Re: Multi-National Clinical TrialsYou are right, unfortunately, due to poor system, lack of interest of senior ones, dishonesty, corruption will never let our country progress. You can take an example of this website, it is online from last 3 years, without any funds or support, and it is run by a single person, who himself is a doctor doing postgraduation. Just imagine, how much talent our country has, and nobody is willing to support. The same is the case with medical research. Even our professors do not enough about research, and how will they tell students about the importance of research ?
Posted by: yasir Posts: 90 :: 29-09-2003 :: | Reply to this Message
Re: Multi-National Clinical Trials
mr yasir please e-mail me at mustafvi@aol.com and lets see what we can do.
taseer
Posted by: drcheema Posts: 4 :: 07-10-2003 :: | Reply to this Message
Re: Multi-National Clinical Trials
Dear Yamin
I am working as a Director Research, National Research institue of Fertility care,Karachi. Our Institue do conduct studies and Clinical Trial on Contraceptive products in Pakistan. NRIFC is one of the WHO Collaborative Research Institue in Reproductive Health Research for Pakistan. We also are working closely with UNFPA, USAID, FHI and other national orgnisations. Our staff is trained and we are capable in implimanting all required formalties as we are working with WHO on some of the Multicentre studies
Badar Abbasi
Posted by: Badar Abba Posts: 2 :: 11-04-2004 :: | Reply to this Message
Re: Multi-National Clinical Trials
Salaam,
It seems things are not as poor as some people have envisaged. It is refreshing to read that Pakistan is participating in international clinicla studies. Inshallah, things will improve further with time.
I will be looking to place potential future studies in Pakistan if possible. Of course, in the current circumstances it is difficult to persuade the larger pharma companies to go to Pakistan as they view it as an unstable part of the world.
However, I will keep trying.
Regards
Yamin
Posted by: ymkhan Posts: 4 :: 27-04-2004 :: | Reply to this Message
Re: Multi-National Clinical TrialsThe point is not the research - it is the ethics and honesty - and sorry to say in Pakistan both are lacking. The patients' rights are nonexistent, researchers falcify data and sometimes even invent data, and there is a culture of bureaucracy. Even if very lousy "paper" is written by a high up it is accepted for publication locally - giving a false perseption of research. unless there is a culture of honest research at the top, very strict regulatory bodies to safeguard patients' interests, thorough vetting of the research papers submitted and proper indexing of medical journals, there can never be authentic reliable research in Pakistan. It is in your own interest to promote all these things, so as to give credibility to the few people who do honest research
Posted by: nukedoc Posts: 6 :: 15-05-2004 :: | Reply to this Message
Re: Multi-National Clinical TrialsI am also interested in the same thing buz i work as an administrator of research in USA and been thinking about business plus ethical point of view. let see. and talk more about it. i have quiried some
Posted by: chakwal11 Posts: 2 :: 22-09-2009 :: | Reply to this Message
Re: Re: Multi-National Clinical Trials
salam
u are right, here our senior colleagues write a paper without collecting any data. i wonder from where they write article? they just copy others research paper and do thier job..
we should first stop this practice..
then we can do research and become reliable, so international journal will accept our research..the present conditions are very dissappointing..lets join hands to make our country a reliable and the best in this regard as well.
thanks
Posted by: tariq khan Posts: 5 :: 23-09-2009 :: | Reply to this Message
Re: Re: Re: Multi-National Clinical TrialsSir. at Karachi, AKU and SIUT have their ETHICAL REVIEW COMMETTES (ERC).
Posted by: BVHOSPITAL Posts: 131 :: 24-09-2009 :: | Reply to this Message
Re: Re: Re: Multi-National Clinical Trials
Salaam.
It is okay to use previous research findings to formulate a new research paper. It’s actually called “pooling of data” OR META-ANALYSIS. I have been in the clinical research industry for over 5 years now in the US and the question of Pakistan's participation in clinical trials has been discussed on several occasions.
Most of the glitches/weaknesses being unveiled on this forum with respect to the conduct of medical research in Pakistan are the same issues faced by China and India. The question is "what makes our neighbors different and attractive to pharmaceutical companies around the world?" and the answers are straightforward:
1. Link China and India, we as Pakistanis need to seek resolve as opposed keep soliciting the flaws within our country.
2. We need to believe that we can do it and move forward with a positive attitude.
3. There isn't a better advocate of Ethics than ISLAM, alhamhulillah, and we can easily use our religion to our advantage and make the necessary changes needed to cultivate the clinical trials arena at the global level. These changes will take time, but taking initiative is the first step.
We need to MARKET our services and quality rather than discredit them. This is exactly what China and India did it. We have to build investor confidence, not just expect it to come on a silver platter.
My fellow friends, Pakistan houses some of the most robust medical knowledge/talent. We need to take advantage of this strength by taking a positive stance and, inshallah, we will be no less than India or China in becoming a major contributor in the area of medical research & drug development.
I urge everyone to visit the www.fda.gov and http://www.reg-info.com/ct_directive.htm websites as many have used this indispensable source to learn and teach clinical trials as a science and to learn/teach the ethical principles of clinical trials.
[Edited by msyed786 on 11-11-2009 at 12:28 AM GMT]
Posted by: msyed786 Posts: 2 :: 11-11-2009 :: | Reply to this Message
Re: Multi-National Clinical Trials
Dear Dr Syed
Thank you very much for an excellent post and the links you mentioned at the end. I agree with you that we don't have any dearth of talent but we do lack a resolve to do honest and genuine research..
I hope that you will keep on sharing your knowledge with us on this ( most active medical) forum in Pakistan
Regards and Thanks again
Farooq
[Edited by drrathore on 11-11-2009 at 11:36 AM GMT]
Posted by: drrathore Posts: 428 :: 11-11-2009 :: | Reply to this Message
Re: Re: Multi-National Clinical TrialsUS based doctors would like to conduct clinical trials in Karachi. We need to recruit doctors trained in this field. Also we need someone to work as a manager( to look at all the aspects of clinical trials, regulatory, etc and to setup everything). regards
Posted by: globalone Posts: 3 :: 27-12-2009 :: | Reply to this Message
Re: Multi-National Clinical Trials
Salam,
I have worked for a local CRO, for 2 studies sponsered by Bayer.
The studies are completed now and if you
are starting some new studies, kindly consider me for that.
Regards
Dr. Ali
Posted by: zaidiali Posts: 2 :: 20-04-2010 :: | Reply to this Message
Re: Re: Multi-National Clinical Trials
Dear Yamin I am the owner of Pakistan leading CRO and SMO by the name dimension Research in fact I have initiated the CRO&SMO business in Pakistan back in 2005.I am also working as an advisor in the R&D committee ministry of health. We are invovled in the conduct of Phase II to Phase IV multinational registration studies as well as preclinical research in collabroation with our US and UK partners. Please send me a mail on my e-mail address kzk@drcro.com so I could let you know proper and up to date details regarding the clinical research market in Pakistan.
with regards,
Khurram.
Posted by: Dimension Posts: 4 :: 03-08-2010 :: | Reply to this Message
Re: Re: Re: Multi-National Clinical Trials
Sir allow me to introduce myself i am Khurram Zaki Khan the CEO of Dimension Research the leading CRO&SMo of Pakistan. I like to know more abut your plans to involve Pakistan in clinical trials please send me a mail on my address kzk@drcro.com and do visit our web site www.drcro.com for details.
With regards,
Khurram
Posted by: Dimension Posts: 4 :: 03-08-2010 :: | Reply to this Message