2^nd International Conference on Clinical Trials August 22-24, 2016 Philadelphia, Pennsylvania, USA

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.

Supreet Kaur Gill has completed her Bachelor of Dental Surgery from Adesh Institute of Dental Sciences and Research, Baba Farid University of Health Sciences, India. Currently she is pursuing her Post-graduation (MSc) in Clinical Research from University Centre of Excellence in Research, Baba Farid University of Health Sciences, India. She has published one paper in Asian Journal of Pharmaceutics and Clinical Research.

Clinical research is making toiling efforts for promotion and wellbeing of the health status of the people. There is a rapid increase in number and severity of diseases like cancer, hepatitis, HIV etc., resulting in high morbidity and mortality. Clinical research involves drug discovery and development whereas clinical trials are performed to establish safety and efficacy of drugs. Drug discovery is a long process starting with the target identification, validation and lead optimization. This is followed by the preclinical trials, intensive clinical trials and eventually post marketing vigilance for drug safety. Softwares and the bioinformatics tools play a great role not only in the drug discovery but also in drug development. It involves the use of informatics in the development of new knowledge pertaining to health and disease, data management during clinical trials and to use clinical data for secondary research. In addition, new technology likes molecular docking, molecular dynamics simulation, proteomics and quantitative structure activity relationship in clinical research results in faster and easier drug discovery process. During the preclinical trials, the software is used for randomization to remove bias and to plan study design. In clinical trials software like electronic data capture, Remote data capture and electronic case report form (eCRF) is used to store the data. The eClinical, Oracle clinical are softwares used for clinical data management and for statistical analysis of the data. After the drug is marketed the safety of a drug could be monitored by drug safety software like Oracle Argus or ARISg. Therefore, softwares are used from the very early stages of drug designing to drug development, clinical trials and during pharmacovigilance. This review describes different aspects related to application of computers and bioinformatics in drug designing, discovery and development, formulation designing and clinical research.