Clinical Research Office
Clinical Research Office (CRO) is involved in a spectrum of key tasks involving research. With close supervision of leadership, CRO is involved in development and dissemination of research guidelines which define the scientific standards and code of ethical conduct of research involving human subjects, which should be followed by all researchers. See guidelines for research
To ensure that all research conducted at the Hospital is in accordance with internationally recognized guidelines; our research guidelines include a well-defined selection and review process for all research activities. This process calls for a review of the study by the Scientific Review Committee for scientific validity followed by a review by the Institutional Review Board which safeguards the well-being and rights of human subjects who participate in the research. The Institutional Review Board is composed of members from various walks of life with both external and internal members; the chairperson is always a non-SKMCH&RC individual to ensure an unbiased review of research. To further the awareness of ethical conduct of research amongst our physician researchers, the CRO conducts a number of educational activities many of which are accredited by AACME including continuing medical education sessions and sessions during the annual Shaukat Khanum Cancer Symposium The office also runs a research oversight programme which involves education for investigators, especially those without prior research experience, to promote compliance to ethics review standards and responsible research conduct
The Clinical Research Office (CRO) is actively involved in several research studies in collaboration with both national and international leading research institutes. It acts as liaison between institution and other national and international research groups thus helping in project coordination and grants management. It also facilitates investigator initiated research studies at the Hospital.
A key function of CRO is coordination of clinical trials. Over the years, CRO has facilitated clinical trials in different phases and diverse therapeutic areas. Clinical trials are considered amongst the most sophisticated research designs producing evidence of the highest authority. A clinical trial is the process through which a drug is licensed to be marketed for clinical use and hence is subject to highest regulatory oversight. With the clinical specialist serving as main clinical lead, clinical research office plays a central role in clinical trials, throughout the research life cycle. Clinical research officers, well trained in good clinical practice guidelines and trial operations, are the main advocates of patients who participate in clinical trials and also liaise with clinical staff, funding bodies and regulatory bodies. Over time, CRO has established an efficient infrastructure to recruit research participants in clinical trials. We have trained a large pool of clinical team members from various departments in the international standards and SOPs for the conduct of clinical trials, making us a site with one of the largest trained workforce for research in the country. SKMCH&RC is involved in international multicentre investigational drug trials as well as pragmatic trials with academic research groups. CRO has effectively met the targets in these trials and this performance has established SKMCH&RC as a preferred destination for clinical trials in the region. The quality of our research output in clinical trials has also been formally evaluated via third party independent audits, regulatory inspections and monitoring audits by research sponsor teams and has been found to be at par with international standards.
Physician investigators of SKMCH&RC are enthusiastic to perform research into causes and treatments of cancer hence a large number of prospective studies were initiated this year in the hospital. In addition, the existing data has also been increasingly utilized to collect evidence to answer certain research questions in the form of retrospective studies. Research scientists at SKMCH&RC, specialized in the field of genetics and proteomics, are contributing results unique to Pakistani population; clinical research office has also been involved in coordination of these projects.
Expertise, infrastructure and research culture at SKMCH&RC has attracted new national and international collaborations. These collaborations are focusing on oncology (such as role of HPV in cervical cancer and oral cancer) as well as at areas other than cancer like infectious diseases, diabetes and cardiovascular disease, high priority research areas for Pakistan. During the current pandemic the focus of research efforts also included research into prevention and treatment for COVID -19. As new collaborations are established, the ones from past have matured and are producing exciting results which are being published. We regularly publish results from these collaborations in peer reviewed journals and present these at local and international research meetings and symposia.
The research office is also involved in teaching and training activities related to research and research ethics both within and outside the Hospital. During recent years members of our team presented our work at the World conferences on research integrity, WCRI (Bangkok 2019 and Cape Town , 2022) , APPNA Merit webinar series on clinical research landscape in Pakistan , The Global Health Network (TGHN) annual conference in Cape Town , November 2022 and London Global Cancer Week (LGCW) in 2020 and 2022 . As part of our commitment to work towards health research capacity building in Pakistan, we have also set up a coordinating centre with The Global Health Network (TGHN), University of Oxford, UK. The goal of this new collaboration is to work towards enabling research in every healthcare setting by sharing knowledge and methods. TGHN is a vast community of practice (https://tghn.org/), with more than a decade of experience and which aims to embed research in every healthcare setting. Details of the network activities and updates from Pakistan are available from the link below
Research office has also been involved in scholarly activities of the global ‘Preparedness Planning for Clinical Research during Public Health Emergencies (PREP)’ coalition and its continuation as the Global Forum for Research Ethics and Integrity [GFREI]. The Global Forum for Research Ethics and Integrity [GFREI] is an open, global, collaborative forum of individuals from 30+ countries focused on research ethics and research integrity, primarily in biomedical research and clinical practice.
CRO also serves as the main link between research and patients. Information for patient related research can be found at Patient Information Guides.