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. 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 workforces for research in the country. The Clinical Trials Unit (CTU) is a dedicated area for clinical trial activities, started working in Sep 2024. In addition to the CTU, the hospital provides a range of other essential services to support clinical trials, including, but not limited to, the main pharmacy (which has a dedicated and controlled space for IMP storage), radiology, pathology laboratory, emergency assessment room, ICU, and both inpatient and outpatient services. All operations are governed by Research Guidelines, and well-established SOPs ensuring patient safety and data integrity. 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.
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:
Pakistan Country Centre • The Global Health Network Asia (tghn.org)
Patient information brochure for research is available (Patient Information Brochure English | Urdu ). It is also available on OPD counters and in the Clinical Research office. A number of research studies, in diverse areas related primarily to the diagnosis and treatment of cancer, are underway in our Hospitals at any given time. Clinical Research officers and study teams actively approach potential participants for participation in research and provide them comprehensive information to help them make fully informed decision about their participation in research. This include information about purpose and scope of research, procedures involved, risks, benefits, alternatives to participation, right to refuse participation in research and their right to privacy, confidentiality, and safety.
