RECAP: RESEARCH CAPACITY for PAKISTAN

I am a US Board certified Internist/ Nephrologist and educator-researcher who has contributed as an instrument of change over the past 33 years in the following roles:

a) Coordinated a new /innovative modular integrated curriculum  at Shifa College of Medicine which set into motion a nationwide movement (2004-2008)

b) Have served as Chair Medicine in Saudi Arabia and Pakistan and developed nearly 40 multidisciplinary clinical pathways that helped in JCIA accreditation in three diverse institutions.

c) Served as inaugural Clinical  Research Director/ Dean/Chair in three Islamabad based institutions : Shifa International Hospital, National University of Medical Sciences and Maroof International Hospital and trained nearly 400 early to mid career gender -balanced multidisciplinary health professionals over 5 years as NIH USA Introduction to Principles and practice of clinical research (IPPCR) remote site chair.

d) Developed  15 year vision for research and academic development at National University of Medical sciences, Pakistan 2016-2019

1. I aim to solve the problem of poor quality clinical research and manuscripts emanating from health professionals in Pakistan.

2. I propose a series of web based intense 2 monthly courses using NIH USA IPPCR 39 lecture course,  on a Monday to Friday schedule between November1, 2020- June 30, 2021 and repeating the process between Nov 1 2021- June 30, 2022 . Each cohort would have 75 online participants for 90 minute sessions using a flipped classroom format further split into 15 member mentored sub groups and weekly office hours .  450  health professionals  will be trained over two years.

3. By enhancing  capacity for critical appraisal of literature, formulating novel, ethical , relevant questions , supported by valid study designs, Pakistan with a 220 M population can more meaningfully contribute to solving national and global health problems exemplified by extended drug resistant Tuberculosis, Malaria and now Covid -19.

It is the poor capacity to do clinical research that is a barrier to the globalization of clinical research ( Ethical and scientific implications of the globalization of clinical research NEJM: Feb 19, 2009)

On an average, Pakistan produces one Pubmed referenced paper every year per over 100 physicians compared with Canada where 4 physicians on an average produce a PubMed referenced manuscript ( Quadri, KHM : Paper presented at First Evidence based healthcare international conference in New Delhi, 2011). Scientific literature relevant to clinical research which in turn impacts evidence based care delivery is not adequately representative of South Asian health problems as the US, UK, Canada, China and European Union contribute principally. A country of 220 Million is thus languishing at the bottom and healthcare is not evidence informed as most international research is not generalizable to the distinct Pakistani population. Our genetic polymorphism dictates a varied pharmacogenomics response and hence studies done in ethnically diverse populations are required to be conducted in this distinct population.

Our Medical colleges do not address clinical research methodology as mentors  themselves are ill- informed.  Our postgraduate certification body  does 3 day research methodology workshops for supervisors and trainees,  exacerbating the problem.

The NIH IPPCR course is a 39 lecture course over 5 modules that is an online  course. Registrants are from a worldwide audience. There is a  certification exam at the end of the course.

I have been leading this course  since 2015 and have trained Doctors, Nurses, Pharmacists, Physical therapists, epidemiologists, biostatisticians, biological scientists, educationists as well as A level students, medical students, residents and fellows.

As a site mentor, I have coordinators who send the online 60-90 minute video and powerpoint presentations, book chapters ahead of time and  participants are expected to be prepared for the sessions which have been live and zoom based in 2020.

At each session, I pose queries serially to most participants regarding concepts such as hypothesis testing, Type I error, Type 11 error, study designs, internal and external validity, reliability of measures, randomization, blinding, allocation concealment and intention to treat analyses as relevant to Randomized controlled trials or corresponding observational study designs respectively.

Since the feedback has been positive from the online participants and usually 95 percent are successful in certifying, I believe the efforts at capacity building have translated into multiple research proposals that our IRBs at three centers in Islamabad have  received.

I have been engaged with multidisciplinary health professions during the past five years. The major benefit is that a continuing inter-health professional learning environment has been seeded in three major centers. Learning to collaborate in teams, critical appraisal of literature and understanding the need for nationally relevant translational research projects have been  key outcomes. Our doctoral scientists are often from non-medical backgrounds and have been used to working in silos on problems that are frequently aligned with work done in overseas labs ,not directly applicable to Pakistan's needs. At the National University of Medical sciences, as the inaugural Dean  I along with the  Research Director put together several research priorities. Once the NIH IPPCR was delivered, I focused on NIH Principles of Clinical Pharmacology and subsequently NIH Bioethics. The result was that we put together the concept for a 200, 000 square feet Nums institute of advanced studies and research and eight core translational research projects. At Maroof International Hospital, a community based academic center where I practice Consultative Nephrology, as their Research Chair, I have identified gaps in critical appraisal through journal clubs, which subsequently resulted in delivering NIH IPPCR to a diverse group,  thus directly seeding this proposal.

The capacity enhancement in clinical trials will help strengthen the tripod of clinical research, quality of care and education that are the hallmarks of academic medical centers.

By utilizing my research department platform and combining it with Information technology tools and a cohort of mentors from diverse health professions background, I hope to seed a nation wide effort to educate health professionals in clinical research methodology.

I intend to use examples related to the current global covid 19 pandemic including articles, case studies and local disease patterns to help develop a sense of urgency in combating this challenging global crisis.

I was not  trained as a clinical researcher myself, during my formative years . However as a Fellow and faculty member at University of Pittsburgh, I had a good mentored experience and this was enhanced through team based clinical research projects in KSA as a Nephrologist working in an academic setup.  I was exposed to Evidence based Medicine workshops at the mid-career stage in 2005 . The facilitator was Professor Gordon Guyatt, whose brilliant teaching methodology was a major inspiration. Subsequently I enrolled in the Harvard Principles and practice of clinical research intense 9 month postgraduate certification course in 2011 and Professor Felipe Fregni and team reinforced my clinical research education capacity . I have conducted workshops as a co-facilitator with both Professor Guyatt and Professor Fregni on two occasions each and realize my innate potential to continue this work. The experience as an NIH remote site IPPCR Chair past 5 years has tooled and motivated me to share my experience and understanding of clinical research methodology, using adult learning principles and flipped class room team based learning formats. Having recently applied for a Canadian CFLI grant to seed a clinical research center,  this MIT Solve project assumes great relevance.

I have been mentored by icons such as Professor Gordon Guyatt, the 'father of EBM' and Professor Felipe Fregni ( HSPH) internationally and late Professors Naeem Jafarey  and Muhammad Amin nationally. These personalities have shaped health professions educational transformation, globally and nationally respectively. The spirit of inquiry, critical reasoning and appraisal has been seeded during my 30 plus year association with these intellectual giants.

On a personal note, I have been recognized internationally as a teacher and facilitator. Whereas Clinical Nephrology is very much a profession, Evidence based healthcare and clinical research is a passion. Through repeated facilitation of seemingly difficult concepts, I have realized that there is a 'famine' in Pakistan as far as research endeavors are concerned, which directly impacts patient care. I believe, it is simply a "fear of the unknown" phenomenon that often used to challenge me during my Internal Medicine Residency journal clubs.

Having overcome this personal challenge , I believe I am now well positioned to motivate early and mid career professionals myself.

Since the global covid-19 crisis started, I have contributed to public opinion newspaper articles ( Naya Daur: Dr Mujtaba Quadri)  including  on a mandatory need for capacity building in clinical research.

I am a practicing clinician who works with a multidisciplinary Nephrology team and understands the importance of team-based care.

As an educator, I have mentored students, residents and fellows and understand the gaps in their training. I also have seen that once concepts are understood, research proposal quantity and quality goes up significantly. This was my experience as inaugural Director, Shifa Clinical Research Center

As an inaugural Dean, Research, at our National University of Medical sciences, I have seen the benefits of delivering the NIH IPPCR Course to 140 translational researchers

As a Harvard certified clinical researcher, I have an in-depth understanding of clinical research methodology.

I have secured clinical research grants of 344, 000 SR in KSA as a direct benefit of my Harvard research certification.

As NIH remote site IPPCR course chair, I have trained 400 health professionals in early to mid career phases.

As an inaugural research Chair, seeking to seed a clinical research center in my current institute through Canadian CFLI grants, to be announced shortly, I believe I have a competitive chance .

This project on a nationwide basis carries weight, as I was recently appointed Chair for a Ministry of Science and Technology, Pakistan  clinical trial standing committee. I helped develop a proposal under consideration for a capacity building national clinical research institute and a 250 bed National Clinical research hospital on the pattern of NIH clinical Center, USA.

Thus,I believe I am well positioned to lead a national clinical research capacity enhancement project.

I contributed to the concept of Nums institute of advanced studies and research at the National University of Medical Sciences. Because of my passion for this project, I set aside for three years my career as a US Board certified Nephrologist, since this was a full time appointment. The project was unusually delayed having initially been set for construction by 2018 and initiation of clinical trials by 2019. Because of structural delays, it was very difficult for me to motivate the University clinical research team. The NIH IPPCR over two years in 2018 and 2019 provided me the opportunity to keep both the clinical research team as well as the basic scientists actively engaged around a collaborative 6 month learning experience. Add to that, NIH principles of clinical pharmacology and NIH Bioethics, which kept the entire cohort of 40 basic scientists and 15 initial clinical researchers motivated and built their translational research capacity in the process.

After completing my inaugural Deanship term of three years, I felt the need to resume clinical Nephrology, another deficiency in Pakistan, but have not given up my goals for research capacity enhancement. I continue to collaborate  with the National University of Medical sciences.

I have served as an instrument of change in Pakistan in medical education, seeding the spiral modular integrated curriculum at Shifa College of Medicine.  Additionally I have introduced evidence based Medicine in several institutions, inclusive of Shifa. I have had a transformational influence on Clinical research education and enjoy a successful nationwide reputation as an academic Nephrologist.

 As a service to the young health professionals, I have put together a book entitled :" Discover the Ibne Sina within" This is a roadmap for young medical students that maps out their expected roles as they negotiate five years of medical schooling with a particular emphasis on translational research. I have alluded to the polymath Avicenna as a role model, so that students may uncover their full innate potential. The book is available online and on my Linkedin account and being published by the National University of Medical sciences.

I  developed a 15 year research vision for the National University of Medical sciences for Pakistan, as inaugural Dean and seeded a culture of critical thinking at this high impact university.

I have an established track record as Chair Medicine, Chair Research, Dean research and academic development internationally/nationally as  my additional testimonials.

I aim to employ a novel Inter-health professional clinical research education format using a Zoom based flipped classroom and collaborative learning model using contemporary case studies , research articles,  satire, humor and role-play.I have had considerable success on the international health professions education stage as a five time performer at the AMEE (Association of Medical Education in Europe)Annual Meeting Fringe sessions which present out of the box approaches to learning and teaching.(See as an example:AMEE Fringe: Cricket, OSCE and portfolios Dr Mujtaba Quadri on Youtube). On another occasion at AMEE Fringe, I taught the research informed consent process by actively enrolling the audience in a clinical trial, to find a cure for their diagnosis "ITTARIC" (inability to take a research informed consent) 

Smaller groups of 15 members with a mentor shall facilitate collaborative learning.

A course normally done once over a 6-8 month period will be delivered 3 times sequentially with a group of research mentees, I have personally previously supervised, as guest facilitators from my previous affiliations

Online strategic celebrations after every module will be done on weekends.

Program evaluation will include online satisfaction surveys

To incentivize application of learning, competitive seed grants of 3000 USD each will be budgeted for 6 well conceived team-based research projects by each successive course cohort,  that will be evaluated by an independent grants committee.

Inter-health professions education will seed mutual respect for diversity and  take root in a country, where class related disparities are often observed amongst genders and various  health professions.

The change anticipated will be a classic logic model delineating outcomes, inputs and processes that inform outcomes. The expected change is facilitated through a snow-balling or Domino effect whereby a series of well trained researchers in the short term are expected to team up in the intermediate time frame to develop competitive research projects for which specified seed grants will be set aside.

The granted projects shall be funded and secondary outputs such as manuscripts and one national meeting presentation shall also have  funding incorporated within the seed grants. 

The certified candidates shall vote for the team player of the group and this certified candidate shall be offered teaching assistantship and mentorship in each subsequent course delivered for a maximum of five opportunities at mentorship after the first course and a minimum of one for the second last cohort trained. In the event, the project is self sustainable, all outstanding participants shall have opportunities to self assess their facilitation skills.

The entire exercise  in turn is expected to lead to multi- institutional seeding of clinical research centers and generation of high quality clinical trials subsequently, which is the definitive output that this project seeks to achieve.

A five year and ten year impact will be measured through alumni affairs in terms of meaningful clinical research projects generated, funded, grants secured , manuscripts and conference presentations.

I have trained nearly 400 researchers thus far over 5 years

With the proposed format, in year one I should be able to train 225 researchers. It is expected that 10-11 institutions shall contribute 20 participants each. This is expected to double in year 2 to 450 researchers

In year five , if sustainable funding is secured, I should be able to cumulatively train 1125 researchers . It is expected that roughly 50 institutions nationwide shall contribute an average of 20 plus participants each.

Year one: Training 225 researchers

Program evaluation:

Number of cumulative Pubmed referenced manuscripts in subsequent five years

Number of cumulative grants in subsequent five years

Number of international conference presentations in subsequent five years

Year five : Training 1125 researchers cumulatively

Number of cumulative Pubmed referenced manuscripts in subsequent five years

Number of cumulative grants in subsequent five years

Number of international conference presentations in subsequent five years

NB : Each cohort will encourage 10 percent participation from regional SAARC countries and neighboring countries thus leading to a transformative change and pluralism in South Asia and allied regions.

Financial: Funding the required teaching assistants and course material inclusive of course textbook NIH IPPCR: Gallin et al in a developing country, particularly for women an minorities from economically challenged backgrounds who make up a significant Nursing and allied health professions workforce

Technical: ZOOM based technology may not be available where internet facilities in certain areas of the country or regionally are unavailable

Legal: Regional regulatory bodies in neighboring SAARC countries approval could be a challenge for securing the stated goals of regional participation

Cultural: National and regional language barriers will need to be overcome through carefully selected group formation with multilingual mentor requirements as English may need to be supplemented by further regional language explanations to clarify difficult concepts.

Market: Competitive research education programs already making an international impact

Financial barriers: Partially through self generated funding like course fee and alternate Canadian CFLI grants applied for

Technical : Using alternate supplementary modalities like Whatsapp groups in areas without DSL technology using prepaid subscriptions to internet packages

Legal: Through SAARC secretariat endorsements to enable participation of regional countries

Cultural : Preferred language based group formation and matching linguistically endowed facilitators

Market : Through the provision of competitive seed grants which most other programs are not offering, to course participants 

NIH USA through NIH IPPCR course as an overseas registered remote site for research capacity building

Harvard School of Public Health: Principles and practice of clinical research through their Alumni Facebook closed group by referring selected candidates for enrollment

National University of Medical Sciences for collaborative projects inclusive of clinical research projects at Maroof international hospital

Rawalpindi Medical University for collaborative research projects such as plasma therapy in covid 19 patients

Each institution served is likely to have 20 plus clinical researchers trained and may be able to host 3 clinical trials year one with expected funding of 40, 000 USD per trial ( cumulative 120, 000 USD)

In year 5  up to 20 clinical trials at a cumulative funding of  800, 000 USD are proposed as a  business proposition.

Universities and national clinical trials consortia and Contract research organizations are likely to be established nationwide.

Pakistani pharmaceutical product exports are barely 250 M USD annually and can be scaled up to 3 B USD annually as a result of seeding of translational research through capacity building inclusive of Phase 1 to 1V clinical trials subsequently.

The program evaluation in terms of number of researchers trained, international manuscripts produced, conference presentations and especially  grants secured and clinical trials conducted shall provide self sustainability to the project long term. 

The Universities and academic medical centers are then likely to take sustained ownership and set aside mandatory R and D funds in their annual budgets .These in turn would be endorsed and funded by Higher Education commission recurring annual Research funding . Follow-up grants would thus be competitive.

Contract research organizations shall be engaged to develop a consortium of nation wide and regional clinical trial sites which shall bring in international academic and industry sponsored clinical trials and sustainability to the entire venture.

For the Maroof Clinical research center project, I have requested 30,000 Can Dollar grant through CFLI local funds specific for Pakistan and expect to hear back soon as the deadline for submission was June 14, 2020 and project shall potentially fund in part the first 6 months . 

Seed grants in kind for establishing a clinical research center inclusive of space, human resource, Information technology facilities have been committed by Maroof International Hospital to the tune of 5,000 dollars.

Course fee at PKR 16000 equivalent to 100 USD per participant and 200 USD for regional participants shall be invested in further capacity building and human resource hiring .

Thus for any cohort of 75 participants excluding subsidies and scholarships for 25 financially challenged Nursing and allied professionals to the tune of 2500 dollars maximum, 50 paying participants enrollment is expected to generate 5000 to 6000 dollars assuming 10 percent regional countries enrollment.

This is in addition to the potential MIT SOLVE PRIZE which would help to pay for course directors, faculty, mentors and course material (textbook)

July -Dec 2020               

HR/  Salaries                                      38,000 USD

Physical Infrastructure :                      15, 000 USD

IT and consumables:                             5,000 USD

Legal issues :                                        2,000 USD

Seed grants :                                       10, 000 USD

Scholarships :                                        5, 000 USD

Cumulative:                                         75, 000 USD

The Elevate Prize would serve as a catalyst for change in the 6th most populous country of the world by creating a learning community of multidisciplinary health professionals, tooled with the art and science of clinical research. 

My efforts over 5 years that have trained 400 researchers can be scaled up several fold and lead to knowledge translation ,through this NIH IPPCR course using a web based platform. 

Incentivizing the course directors, faculty, group facilitators, course coordinators, administrative staff, providing the physical infrastructure, and supporting seed grants and legal cover shall overcome several financial, cultural and legal barriers that potential researchers face in the developing world.

The global recognition shall motivate a lot of younger health professionals nationally and regionally to value 'creation of knowledge' and take up clinical research as a prestigious career with sustainable economic benefits on a personal and national level through multi-center clinical trials.

Last but not the least as pointed out in the NEJM article of 2009 referenced earlier, the ethical and scientific barriers to the globalization of clinical research can be overcome through the key aspect identified, which is the capacity to perform high quality research.

The Elevate Prize has the potential to be truly transformative in this highly talented but under-performing community of health professionals.

Funding and revenue model: Financial modeling and revenue generation to ensure long term sustainability with particular reference to risk mitigation strategies would be welcomed.

Legal or regulatory models: Awareness of working models at NIH USA, FDA regulations for drugs and devices would help course directors with the practical regulatory issues in international drug development and conduct of  Phase 1 to 1V clinical trials

NIH (USA): Mid Career clinical research sabbatical opportunities for 4 weeks at NIH clinical center may help key future Maroof Research center leaders/directors learn the tools of clinical research management.

FDA (USA) : A visit of the facility and its regulatory affairs divisions can help in the understanding of legal aspects of clinical drug development.

Harvard School of Public Health PPCR program : Some outstanding candidates may be sponsored for the Harvard PPCR 9 month intense post graduation course through scholarships