Sheraz Ali has completed his MPH degree on scholarship from University of Eastern Finland and PharmD from Baqai Medical University. He is currently working as a Researcher at Pharmaceutical Care Services, King Saud Medical City, Ministry of Health, Saudi Arabia, and involved in several clinical research projects. He also worked as a Clinical Research Associate in CRO and pharmaceutical industry and was a part of local and international clinical trials. He is a registered researcher in Saudi Arabia and also a member of International Society for Disease Surveillance (ISDS).
The clinical trial is an important type of research design in the spectrum of translational research. The extent to which clinical trials are conducted is a reflection of the level of advancement that exists within a healthcare system – a single provider, an organization (e.g. a hospital), or a national healthcare system. This study aims at describing the clinical trial activity within the Kingdom of Saudi Arabia since 2000 through reviewing those trials that have been registered with ClinicalTrials.gov in that time period. Since February 2000, 405 trials have been registered with ClinicalTrials.gov. These trials fall into one of 22 different ICD-10 codes, and with the top four being neoplasms (92), diseases of the circulatory system (57), endocrine, nutritional and metabolic diseases (46), and diseases of the respiratory system (25). Among the 405 trials, about half (200) were classified as trials with both safety and efficacy endpoints. Fifty-two percent were phase IV trials and 28% were phase III. About 64% were randomized, and with about equal numbers of those trials coming from industry (86) and university sponsors (85), and smaller numbers coming from hospitals (51) and other sponsors. Among the 185 university- or hospital-sponsored trials, the most common was a phase IV neoplasm trial (11) and next being a phase IV trial of diseases of the circulatory system (9). A total of 24 phase III university- or hospital-sponsored trials have been registered during the 15-year time period. With a population approaching 30 million and very large annual healthcare expenses, it would appear that the level of clinical trial activity within the Kingdom during the past 15 years has been rather paltry. The emphasis has been on post-marketing phase IV trials. The academic setting (i.e. universities and hospitals) has seen a new trial registered every 11 months on average. This study is solely based upon the information as registered in ClinicalTrials.gov. There is the possibility that other trials not registered could exist. However, it is thought that the resource would include those trials of a higher quality and more rigorous.
Ramandeep Kaur Brar has completed her B.Pharm and currently pursuing MSc in Clinical Research at University Center of Excellence in Research, Baba Farid University of Health Sciences, India. She has published one chapter in book and one Paper “Scope and Bottlenecks in Clinical Trials of Herbal Drugs” in the Journal of Pharmaceutical Research.
Ethics committee is supposed to play a great role in safe human research. It is mandatory that all research projects related to health sciences with involvement of patients/subjects should be approved by IEC before commencement. The data available reflects the low percentage of awareness amongst the routine project investigator. Being inclined towards medical education only, awareness amongst faculty members of medical colleges towards ethics committee is also expected not up to the mark. Indian Council of Medical Research has launched and funded development of Multidisciplinary Research Unit (MRU), a scheme for igniting research component in various medical colleges of India. Keeping in view the above situation, a study was designed to check the awareness about the composition, review procedure and functioning of IEC amongst the research scholars/teachers in government medical colleges of Punjab. The information was sought in form of a questionnaire from a total of 50 participants. From the study it was observed that only 10% had undergone ICH-GCP training. A few participants (6%) served as member of IEC and demonstrated a very poor knowledge index about IEC. Only 68.5% participants were aware about its composition and majority of respondents (86%) felt that there was a need of training before becoming a member of IEC. From the data it is very clear that there is strong need of training to faculty of medical colleges towards institutional ethical committee. There is a need to inculcate the IEC-ICH guideline in curriculum of post-graduates medical students and medical teachers.