International Conference on Clinical Trials July 27-29, 2015 Orlando-FL, USA

Hoyoku Nishino has completed his Ph.D at the age of 28 years from Kyoto Prefectural University of Medicine. He is the director of Cancer Control Center at Kyoto Prefectural University of Medicine. He has published 456 papers in the field of "Preventive Medicine".

β-Cryptoxanthin has been shown various aspects of health promoting activities; such as prevention of metabolic syndrome, improvement of liver function, cancer prevention, prevention of osteoporosis, and so on. Cancer preventive activity of β-cryptoxanthin is one of the important aspects. Since the incidence of liver cancer is increasing in the world, it is valuable to develop an effective method for its prevention. We have conducted a clinical trial for liver cancer prevention using natural carotenoids, including β-cryptoxanthin, and other food factors. Combinational use of carotenoids and myo-inositol was found to prevent hepatocellular carcinoma development in patients with chronic viral hepatitis and cirrhosis, significantly. Although the precise mechanism of β-cryptoxanthin on health promoting activities is not known yet, anti-oxidative activity might be important. Further studies on action mechanism of β-cryptoxanthin should be continued.

Helen Snooks is the Professor of Health Services Research in the Swansea University Medical School, UK. She is the Interim Director of the Swansea Trials Unit (STU) and leads the Patient and Population Health and Informatics (PPHI) research stream at Swansea University. Helen’s main research interests and expertise lie in the fields of Emergency Pre-hospital and Unscheduled Care, Clinical Audit and Effectiveness, and research support. The focus of her work is to plan, design and carry out evaluations of health technologies and new models of service delivery. Helen has a Bsc (Hons) Economics, Sociology, Statistics from University of Surrey with a PhD in Health Services Research ‘Post Traumatic Stress Disorder in seriously injured accident victims’ at the University of Sheffield in 2000.

Background: The rise in availability, quality and use of routine health data has resulted in well-developed methods for anonymised linkage of data from multiple sources. However methods for combining identifiable data (e.g. patient-reported questionnaires) with routine anonymised data are not yet tried-and-tested. Linking these data presents opportunities to improve the feasibility and effectiveness of observational and experimental studies, but emerging data linkage processes must address the appropriate balance between data security and usability. Objectives: • To present an efficient privacy-protecting model for linking routine and identifiable patient-reported research data. Methods: The Process for Routine and Identifiable Data Linkage (PRIDaL) was devised to efficiently link routine hospital data and patient-reported quality of life and quality of care questionnaire data as part of the PRISMATIC trial (2) – a mixed methods cluster randomised trial of the efficacy of an emergency admission risk tool in primary care. PRIDAL was conceived by a group of specialists in e-trials, health informatics, information governance and process mapping who reviewed data sources, flows, owners, and security to develop a practical and intuitive process model. Results: We will present the PRIDAL process model for the first time and use PRISMATIC findings from data matching of 2,400 questionnaire responses to patients in an overall study dataset of over 200,000. (Data matching will complete in April 2015). We will demonstrate that the model achieves high matching rate, and consider the lessons learnt in its application. Conclusions: The linking of routine health and patient self-reported data presents valuable research opportunities, but clear, replicable models, are needed to support ethical and practical data linkage. We present the PRIDAL model as a potential solution.

Su-Hui Chen after completing her basic nursing education, she worked for ten years as a staff nurse in a medical center and held joint positions as an Associate Professor at the Chang Gung University of Science and Technology since 2007 in Taiwan. She earned Doctoral degree in nursing at The University of Texas at Austin, USA, in 2007. Her specialty is interesting in gerontology nursing.

Background: Rheumatoid arthritis (RA) is a persistent systemic disease, and patients will live with the disease longer because the increase of the life expectancy. WHO commented that a crucial goal of treatment for RA is prevention of loss of daily function by patients’ self-management (SM) skills. In Taiwan, the treatment of RA is often focuses on the biomedical aspects and patient education is mainly through brief and infrequent interactions with the healthcare system. A comprehensive self-management strategy for patients’ day-to-day self-management is limited.
Aims: The primary objective is to determine the feasibility and acceptability of the SM for patients with RA especially focus on joint activity and joint protection. The secondary objective is to determine the effectiveness and appropriateness of the program with a focus on physical function and patient reported measurements over a 12 months follow-up.
Methods: To achieve the research goal, the three years of this proposal will be divided into two phases. The phase-1 will conduct to develop the program and psychometric test of the instruments and to pilot test the feasibility of the research protocol. Regarding the phase-2 study, the main purpose is to implement the SM intervention for people with RA using experimental design. A medical center in northern Taiwan will be selected as the research setting and the permission to recruit participants will be obtained from the director of the medical center before data collection. Patients who visited the rheumatology departments of the medical center will be eligible for the study. The inclusion criteria show as follows: (1) diagnosed with RA, (2) age of 20 years or over, (3) disease considered by the treating rheumatologist to have been stable for at least 3 months, (4) no surgery planned in the 12 months from study baseline and (5) able to understand and comply with the study treatment. Patients will be excluded if they are suffering from other terminal illnesses, severe dementia or another debilitating psychiatric disorder, living in a long-term care facility and participation in another research protocol. After completion of baseline measurements, patients will be randomly allocated to the intervention or control group using a computerized allocation procedure. The sample size estimation will based on the Generalized Estimating Equations (GEE) analysis. After analysis, the minimum participants for each group will be 130 persons yield a 15% dropout rate. Control patients received usual care, consisting of regular checkups with the rheumatologists. Patients allocated to the intervention group received the 8-week SM in addition to usual care. The program focuses on joint activity and joint protection SM based on Bandura’s self-efficacy theory. The independent variable of the SM intervention is based on four information sources of efficacy expectations include mastery experience, social modeling, social persuasion and physical and emotional states. The strategies using to enhance SM behavior involve education, goal setting and attainment, self-monitoring, home visit and telephones delivered. All participants will follow up for 12 months and the data will be collected in the baseline and 2, 3, 6 and 12 months. The descriptive and inferential statistics with the GEE analysis will be used to evaluate the intervention outcomes such as the Disease Activity Score-28 (DAS-28), arthritis self-efficacy scale, health assessment questionnaire, quality of life measure (SF-36), self-management behaviors and health care utilization. And, in the end of the study, the satisfaction with the self-management will also be evaluated for the experimental group. The results of this project would benefit for RA patients and health care professionals to generate an effective SM model.

Ramandeep Kaur Romana, completed her graduation in Nursing (from Malwa College of Nursing, Kotkapura, India) in year 2011. Subsequently, she had about one and half years of extensive experience as bedside nurse. Currently, she is doing M.Sc in clinical research from (University centre of excellence in research, Baba Farid University of Health & Sciences, Faridkot).

Ramandeep Kaur Romana, completed her graduation in Nursing (from Malwa College of Nursing, Kotkapura, India) in year 2011. Subsequently, she had about one and half years of extensive experience as bedside nurse. Currently, she is doing M.Sc in clinical research from (University centre of excellence in research, Baba Farid University of Health & Sciences, Faridkot).

Ibrahim Khalil AL Ibrahim is a 4th year dental student at College of Dentistry in the University of Hail. He is a strong advocate for volunteer work and sharing happiness with everyone. He is a good reader and a weekly opinion writer at Makkah newspaper. He is involved in students activity since early childhood school. He was a President of Student Activity Club in both intermediate and high schools. He is now a Vice President of “Together for a Beautiful Smile Club” at college of dentistry and an ambassador of “Traffic Safety volunteer Group” in Hail city. He involved last year in many activities such as Hail Rally, Dessert Festival and Traffic Safety week. His professional interests focus on increasing awareness and good oral hygiene among the community. His current project “High Rates of Discoloration and Dental Caries among the Smokers of Hail Region and Inheritance of PTC Gene” which won the first prize in medical research field at the University of Hail. He recently received an excellence prize for his outstanding academic performance from the University of Hail

Background: Smoking has been a global problem for decades. Globally there are one billion smokers. On an average a smoker dies about 10 years earlier than a non smoker. According to WHO, every 6.2 seconds one current or an Ex smoker dies (more than 5 million deaths per year). WHO also estimates that yearly more than 600,000 people die due to second hand smoke (one death every 51.4 seconds). If this trend continues the WHO estimates the death toll among tobacco users will rise to about eight million (one every 3.9 seconds) per year by 2030. Objectives: Due to this alarming forecast we decided to estimate the number of smokers in our community (youths and the senior citizens), assess their oral health and to raise awareness about dangers of smoking. Methods: Since smoking is global problem and smokers are found in every gender and age group, we decided to estimate the number of smokers in Hail community and the state of their general and dental health. A questionnaire was distributed among the community members and their responses were analyzed. In addition to the distributed questionnaires more than 200 members (age range 15-75) were directly interviewed and their oral cavity was thoroughly checked for tooth decay. Results: Based on our data analysis (n=200) we found 34.5% smokers. We found 22.5% of the parents to be smokers also. There was no statistical difference in the number of smokers between the educated and the non educated community members. Incidences of dental caries, oral cancers and fluorosis were significantly higher among the smokers. We then interviewed oral surgeons in the area. According to the area dentists at an average about 81% of their patients were smokers and 39% of their patients had diabetes. Most of these dentists (60%) reported seeing Dental caries as most prevalent followed by periodontitis and periapical abscess cases in the Hail community. 50% of dentists also reported seeing adenocarcinoma cases among their patients. Conclusion: The number of smokers is shockingly high among our youths and the senior citizens of this area. The government should ban smoking in all government buildings, schools and other common public places.

Jung-Hua Shao during her PhD degree greatly improved her research skills. After starting her career, she is interested in self-management program, especially for elderly people with chronic disease. She got two research grants from government in Taiwan that support her to process the self-management program for elderly people with heart failure and osteoarthritis. Moreover, she has published research results in different journals already. Those experiences led her to think about continuing to do research into quality of life for elderly peoples, it also builds up his research practice ability.

Background: Heart failure (HF) is a chronic, disabling disorder which is mainly found in older people is one of the leading causes of hospitalization and readmission around the world. Self-management (SM) is an approach to care of those with chronic illness and therefore has potential to decrease HF patients’ hospitalization and costs and also to enhance these patients’ quality of life, self-care and self-efficacy.
Aim: The study aims are to develop, implement and examine the effects of a SM intervention in older people with HF, over a 12 months follow-up.
Methods: An experimental design will be used. One hundred and fifty subjects from two medical centers of Taiwan will be randomly assigned to the intervention and control groups. In order to examine the effects of SM, data collection at baseline, three months, six months and twelve months will include the following instruments: Self-efficacy for salt and fluid control, HF SM behavior, HF-related symptoms, depressive symptoms, HF-related quality of life, daily weight monitoring and HF-related health services utilization. An individualized self-management training program will be implemented for the intervention group. Furthermore, this program will emphasize self-monitoring of diet control for heart failure. The aim is to improve patients’ self-efficacy for their diet control behavior. The “diet control” in this study will focus on sodium and fluid restriction. Outcome measures of this study will be analyzed using descriptive and inferential statistics with the generalized estimating equations (GEE) analysis. The findings of this study would generate an effective SM model for health professional to facilitate HF patients the development of self-care capability and improvement of health-related outcomes.

Helen Snooks is the Professor of Health Services Research in the Swansea University Medical School, UK. She is the Interim Director of the Swansea Trials Unit (STU) and leads the Patient and Population Health and Informatics (PPHI) research stream at Swansea University. Helen’s main research interests and expertise lie in the fields of Emergency Pre-hospital and Unscheduled Care, Clinical Audit and Effectiveness, and research support. The focus of her work is to plan, design and carry out evaluations of health technologies and new models of service delivery. Helen has a Bsc (Hons) Economics, Sociology, Statistics from University of Surrey with a PhD in Health Services Research ‘Post Traumatic Stress Disorder in seriously injured accident victims’ at the University of Sheffield in 2000.

Background: Primary care doctors are encouraged to use predictive risk tools to identify patients who might benefit from community-based interventions and so avoid inappropriate emergency admissions. Objectives: As part of a trial of the Prism predictive risk tool in Wales, UK, we aimed to understand how and why it might, or might not, be adopted by practitioners. Methods: Before practices received Prism, we held focus groups with 31 doctors and colleagues, and interviewed a further 11. We asked about expectations of Prism use and impact, and any concerns. Three months after implementation, we interviewed 28 doctors and colleagues about their experiences of Prism. We recorded all groups and interviews. We analysed transcripts thematically, informed by Normalisation Process Theory (NPT). Results: Before implementation, respondents were generally supportive of the principle of identifying at-risk patients, already familiar with risk prediction from using condition-specific tools, and willing to trial Prism. It fitted with policy imperatives. There were anxieties about raising patient expectations, and about implications in terms of performance management. Three months after implementation, respondents had found a range of ways of using Prism, and then selecting patients amenable to new interventions. Contractual changes requiring doctors to identify and plan care for 'at risk' patients had been a very strong driver to adoption.

Dr. Supreet Kaur Gill, BDS (Bachelor of Dental Surgery from Adesh institute of Dental Sciences and Research, Bathinda under Baba Farid University of Health Sciences, Faridkot, India). At present she is pursuing her post-graduation in Clinical Research (M.Sc clinical research from University Centre of Excellence in Research, Baba Farid University of Health sciences, Faridkot, India). One paper to be published in Asian journal of pharmaceutical sciences and clinical research. I want to pursue my career in dental product industry as clinical research associate.

Unique eCRF is an electronic platform which maintains and integrates clinical trial subject’s lifetime health care and financial records. Unique eCRF could route authorized person to a private and secure environment to confidentially access, manage and share the health information of a subject. Unique e-CRF has potential of integrating various domains of clinical trial to a unifocal point like data capture, data cleaning, data mining hence significantly contribute in trial management. Unique eCRF helps both in reducing risk and improving efficiency throughout a study by eliminating the need for data reconciliation and the expenses of managing separate systems. Thus, it also contributes in huge saving of a pharmaceutical company in terms of cost and time. Unique eCRF make clinical trial more transparent by allowing real time data asses to all involved parties (clinical trial manager, investigator, sponsor, licensee, regulatory auditors, etc) simultaneously. The other potential advantages include integrated patient’s health and financial data, audit trial capabilities, identifying eligible patients for clinical trials from patient’s records, trial randomisation, agile data transfer, follow patient outcomes, in creating patient registries, monitoring adverse drug reactions and pharmacovigilance reporting. The auto-alerts and correction feature of eCRF will improvise data collection, faster database lock and hence a smart way for data management and quick statistical analysis. However, unique eCRF should be featured in compliance with 21 CFR part 11 requirements which impose extra pressure and a challenge in its design. In addition, the initial cost of adopting this model is quiet heavy.

Objective: To understand patients’ perspectives on clinical research in India Design: A questionnaire based survey was conducted in different parts of India, covering all kind of population. Questionnaires were filled with the help of investigators, physicians, social workers, freelancers, research professionals, etc. Methods: India is said to be the hub of clinical research. It is also equivalently important that the population in India is well aware about the basics of clinical research so that individuals are not treated as “guinea pigs” and the research is conducted with full ethics and good clinical practice. The study was undertaken to analyze the perspective and awareness of clinical research amongst Indian population. Results: There were 20 different parameters/data points for which the data was collected from 6122 patients across the country. As the available data is dichotomous a dynamic analysis was done using a percentile method. Conclusion: Clinical trials in India are conducted in ethical manner but still the understanding of patients remains ambiguous. The data concludes that awareness about clinical research remains low. Awareness will help us bring new therapies to the market. Key Words: Clinical trials, Indian Scenario, Awareness, Patients Perspective, Ethics, Subjects Confidentiality

Ramandeep Kaur completed her Bachelors in Pharmacy (Pandit J.R. Govt. Polytechnic, Hoshiarpur, Punjab India) in 2012. Presently she is pursuing her second year of Masters of Science in Clinical Research from University Centre of Excellence in Research (Baba Farid University of Health Sciences, Faridkot). She has one international publication in Integrative Medicine Research Journal.

Herbal products have always been an important part of the public healthcare across the globe. A report by WHO revealed, that approximately 65-80% of world’s population living in developing countries because of poverty and lack of access to modern medicine depends essentially on plants for their primary healthcare because of being economical, long history of traditional use, better compatibility with human body, minimal side effects, enhanced tolerance and more protection. Herbal products are also prevalent in developed countries like Germany, France, Italy and U.S where required guidelines for registration of herbal medicines exits. Approximately about 25% of all modern medicines are directly or indirectly derived from plant sources. The current market size of herbal medicine is estimated about $80-250 billion in Europe and USA whereas in China is about $650 million. However, the contribution of developing countries in global herbal business is very poor due to the lack of quality control and standardization measures, difficulty in preparing isolated compounds, lack of sufficient safety data including drug interaction, poor information about the composition of herbal preparation, difficulty in selection of dosage regimen, lack of drug delivery platforms, adulteration, difficulty in conducting randomized clinical trials, patient selection, patient motivation, comparative placebo and end point selection, high protocol non-compliance, methodological shortcomings etc. Therefore, these pitfalls in herbal clinical trials must be addressed to generate a sustainable natural source which could cater the ever needing demand of new and safer treatments and in renewing the interest of pharmaceutical companies in herbal medicine research.

Objective: To compare the cytotoxic effect of anticancer drugs OR-2011 on lyophilized liposomal formulation (LLF) and substance on human melanoma cells Mel Kor and Mel Ibr. A new lyophilized liposomal formulation (LLF) OR-2011 was developed for specialized and profound studies in I.M. Sechenov First Moscow State Medical University and in N.N. Blokhin Russian Cancer Research Center. Materials & Methods: A comparison of cytotoxicity of liposomal drugs were performed using the MTT assay based on the restoration of dehydrogenases of metabolically active of living cells yellow salt 3-[4,5-dimethylthiazol-2]-2,5-diphenyltetrazolium bromide (MTT) to form a purple crystals of formazan. The amount of formazan obtained depends of the number of cells and their viability and were determined by photometrically. Cytotoxic effect characterizes the IC50-(concentration of substances that are caused by the death of 50% of the cells) liposomal formulation OR- 2011 and substances OR-2011 were studied in concentrations of 1 mg/ml; 0.5 mg/ml; 0.25 mg/ml; 0.125 mg/ml; 0.062 mg/ml; 0.031 mg/mL and 0.015 mg/ml. Cell lines were cultured in a RPMI-1640 medium containing 10% fetal calf serum (FCS), 10 mM HEPES (Sigma, USA), 2 mM L-glutamine (Sigma, USA), 40 ng/ml gentamicin (ICN, USA) 0.1% 1000-fold solution of amino acid and 0.1% 1000-fold rastvorara vitamins (PanE-Co., Russia) at 37˚ C in an atmosphere of 5% CO2 and 0.1% 1000-fold vitamin solution (PanEco, Russia), at 37˚ C in an atmosphere of 5% CO2. The cells were maintained in logarithmic growth phase of constant reseeding human culture within 3-4 days. For cell detachment with plastic was used versen solution. Cells were washed with serum-free pure RPMI-1640 medium and transplanted in a 96-well flat-bottomed plates (Costar, USA) at 4×103 cells 180 µl of complete medium RPMI-1640 per well. To evaluate the cytotoxic effect of liposomal drugs was added into each well of 20 microliters of various concentrations of drug and incubated with the cells for 24; 48 and 72 hours at 5 %-CO2 incubator at 37˚ C. Results & Conclusions: Cytotoxic effect of OR-2011 was most expressed especially the liposomal forms; After incubating the cells with the drug for 24 hours, the IC50 for liposomal form has been 0.025 mg/ml and for OR-2011 substances-0.125 mg/ml. Further at incubation, 48 and 72 hours IC50 for liposomal formulation remained same values and for the OR-2011 substance has reached 0.062 mg/ml. Thus, study of lyophilized liposomal formulation LLF OR-2011 cytotoxic activity showed more effectively kills neoplastic cells in comparison with the substance OR-2011.

Varley Dias Sousa is Pharmacist (2003) Post-Graduated on Health Surveillance (2007) and International Health Systems (2006) and has completed his MSc (2010). Currently is performing PhD studies at the University of Brasilia. He is a senior Auditor on Brazilian Health Surveillance (ANVISA) since 2005, he has been certified in Good Manufacturing Practices (inspecting international facilities in almost 10 different countries) and Good Clinical and Laboratory Practices (Inspecting more 30 international CROs). He has evaluated more than 150 bioavailability and bioequivalence (BA/BE) studies and more than 150 Medicine Applications. Also, he is the member of the commission in charge of confidentiality classification on Medicine Dossier.

Brazil is 5th biggest pharmaceutical market in the world and the Brazilian Heath Surveillance Agency (ANVISA) isresponsible to evaluate the products quality and safety. The process of expanding access to data on the regulatory framework was highlighted by publication of Federal Law 12.527/2011. Hence, in the field of health regulation, the wide access to data of drugs and related technical documents, especially clinical trials data, is in the expansionat FDA, EMA and ANVISA. A fact to be evaluated is how disclosure policies are built, emphasizing the regulatory impact analysis and detecting the risks and benefits involved. Therefore, is essential the analysis of the legal, technical and ethical aspects involved in the publicity of data, such as: Patent rights, confidentiality of commercial information, privacy of research subjects, rules of engagement for accessing, clinical trials registers, electronic application, as well as defining the limits of access and disclosure. The openness will enable public scrutiny and secondary analysis probably resulting in improvement of the products quality and public health development as well as the social accountability but some boundaries should be respect in order to not frustrate investments on bio-pharmaceutical research and development (R&D) along with not to bias the Agency's decision-making process, hereafter, disclosures policies has substantial impact over Regulatory Environment. Clinical Study Report is essentially significant as contain vital information regard new products, methods and formulations over and above is the primary source of information about the product efficacy.

Ameloblastoma is the most frequently encountered neoplasm arising from the odontogenic epithelium. Beclin 1 protein plays a critical role in autophagy as a tumor suppressor gene. Whereas, the Murine Double Minute 2 (MDM 2) is a cellular proto-oncogene capable, if amplified, of causing tumor-genesis. The expression & prognostic significance of both genes are largely unexplored, yet, in this neoplasia. Therefore, the present investigation aimed to assess their possible biological role in ameloblastomas. Methods: This study was done among 35 studied cases: 29 cases of benign ameloblastomas, and 6 cases of ameloblastic carcinomas. Labeled Streptavidin Biotin (LSAB + Dako) immunohistochemical method, utilizing monoclonal antibodies for Beclin 1 & MDM 2 genes, was used. Results: Most of the benign ameloblastomas showed intense total cell positivity for the Beclin 1, while, the ameloblastic carcinomas revealed mild to negative expression. Inversely, the MDM 2 oncoprotein demonstrated intense brown total cell reactivity in amelobastic carcinoma & loss of the reaction to mild brown stain in benign ameloblastoma. Conclusion: Based from these findings, one could conclude that, MDM 2 could be a specific marker to identify the proliferative activity, tumor aggressiveness & directly proportional with the degree of malignancy. In contrast, the high Beclin 1 expression could be a good indicator of prognosis in ameloblastomas. Hence, an overall comparison, both studied genes may be very promising molecular prognostic biomarkers

Mr Anwar is pharmacist and pharmacologist which he is currently working as lecturer and clinical coordinator in Addis Ababa University. He has been involved in a number of community studies, and community activities which are the interest of the government and the community. As a young researcher he has so far three publications in reputable journal and has two publications in progress. He is applying for PhD study in Pharmacometrics and interested to pursue in this field.

Background: There is a developing consensus on the effectiveness of various interventions for 21 mental disorders in low and middle income countries, and it has been proposed that the main task 22 that remains is to scale up these interventions. In this context we aimed to look at the quality and 23 extent of intervention trials for selected priority mental and neurological disorders in sub- 24 Saharan Africa.
Methods: We used Medline, AJOL and Google scholar databases. Randomized 25 or non randomized clinical trials for the treatment of schizophrenia, depression, maternal 26 depression, bipolar disorder and epilepsy/seizure disorders that involve pharmacotherapy, 27 psychotherapy and physical therapy were included. Extensive list of search terms that identified 28 locations, disorders, interventions and study types were employed. The qualities of the trials 29 were appraised using the single component quality assessment of CONSORT-statement and the 30 Jadad scale.
Results: From 1136 studies identified, only 34 trials that fulfilled inclusion criteria 31 were used for quality analysis. Most studies were clinical trials of treatments for epilepsy and 32 conducted after 2006. In terms of region, South Africa had the lion’s share hosting 22 of the 34 33 studies. Pharmacotherapeutic interventions (71%), and conducted at a single center (53%) 34 predominated. In terms of methodological quality in relation to the Jadad scale, 82% fulfill 35 criteria for good methodological quality with a score of 3-5. However, the methodological 36 quality according to the CONSORT criteria was more mixed.
Conclusions: The overall quality 37 of clinical trials conducted in Sub-Saharan Africa is encouraging despite the limited number. 38 However, important quality limitations remain and have not improved over time. Establishing 39 clinical trial centers in these countries may be one approach to improve quality and quantity of 40 trials.

Saumell is a Clinical Trial Project Manager at the Clinical Research Direction in the Center of Molecular Immunology. Her responsibilities included directly the design and conducting of clinical trials. She has a Master of Science in Health´s Economy and another in Natural Medicine and Bioenergetics. She also attended graduate in Clinical Trials, Pharmacoepidemiology, Biometrics Research and Design, Good Clinical Practice and Monitoring of Clinical Research. She is doing a PhD in Pharmaceutical Sciences at the Havana´s University. She was providing training to various study sites.

Drug safety is investigated during different phases of clinical development, with the aim of establishing a risk-benefit ratio that allows registration and marketing. The management of drug safety during the conduct of clinical trials is considered a key to success and overall results of the pharmaceutical company sponsoring the product under study process, which has among its strategic goals registration and subsequent marketing of its products, based on the efficient collection of reliable data on efficacy and safety. This work constitutes the first stage of a project to implement a safety information management system from our pharmaceutical company. Starting with criteria of structure, process and outcome, 23 indicators with their respective standards were identified. From these, 9 instruments were designed and validated, to assess the management of safety information generated at the sites of research where clinical trials with Molecular Immunology´s Center products are conducted. The feasibility, internal consistency, and content validity of the instruments were investigated. Evaluation was based on statistical methods. As results, the 9 instruments are easy to use, and it produced low missing data. Cronbach’s alpha coefficient ranged from 0.79 to 0.89 for all of them. The 9 instruments demonstrated good psychometric properties and thus are reliable tools for examining drug safety management during the conduct of clinical trials.