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

Biography:

Ajay Francis Christopher, MSc (Molecular Biology & Biochemistry from Guru Nanak Dev University, India) served as PV Scientist, Senior Quality PV Scientist, Trainer cum Mentor and Subject Matter Expert-QAPV for Blue Chip pharmaceutical companies at premier CRO in India. He has over 12 years of experience in Clinical Research and Development and has one Young Scientist Award and various appreciation awards to his credit. He has coded over 5000 ICSRs (SUSAR, serious, non-serious reports) and reviewed over 3000 ICSRs, narratives and SSUR. He successfully led various international projects (global transition in narrative writing for regulatory submission, customization and validation of Oracle Argus Safety 5.0.2, etc).

Abstract:

An adverse event (AE) for an investigational product could be generated during the clinical phase or reported spontaneously by a healthcare professional (HCP) or consumer via phone, fax, mail, literature or any social media. The ICH E2A has laid guidelines for the reporting of AE during clinical trials. Hence, pharmaceutical companies collect thousands of Serious Adverse Events (SAE) reports from a trial and individual case safety reports (ICSRs) from post marketing across many countries. An efficient way to manage the high load of safety reports is via adopting a process flow approach which consists of four basic steps: Case intake, case processing, case review and case reporting. The case intake from a clinical trial is done via SAE reports which are a part of case report form (CRF). The information is provided by a trained HCP and hence requires minimal handing before processing. Whereas, ICSRs are generated from the data mostly collected from non-medical personnel and hence the information is non-standardized and sometimes incomplete. During the second step i.e. case processing, the data is validated against four minimal criteria established by ICH i.e. identifiable patient, reporter, AE and suspected drug. In addition, the data is checked for possible duplication, entered onto safety database with case narratives and AE coded in compliance with the internationally defined standards. The third step i.e. the case processing is of great importance as the ICSRs are evaluated using the three standardized criteria: seriousness (death, life threatening, hospitalization, etc.), expectedness (whether the AE was expected under investigator brochure in a clinical trial or the product label for marketed product and causality assessment (degree of casual relationship between the AE and drug. These three criteria are essential for the establishment of expedited reporting of a safety report. The final step is the case reporting to the regulatory authorities within the timelines defined in the regulations. Hence, the importance of handling safety reports cannot compromised as it help to protect both patient safety and value of product assets of a pharmaceutical company.

Biography:

Petra Bagdi is a psychologist working in the Psychotherapy Department and Outpatient Clinic of the National Centre for Spinal Disorders Budapest in Hungary since 2010. She has being conducted her PhD in Health and Personality Psychology at the University of Pécs’s Doctoral School of Psychology since 2012. She becomes Clinical Psychologist and Hypnotherapist this year. Her research work includes: Pain management, psycho-education for chronic pain patients, assessments of psychological risk factors before surgery, psychological preparation for surgery, and effects of suggestive recordings during general anaesthesia.

Abstract:

There are different types of psychological interventions (e.g. psycho-education, behavioral therapy, cognitive therapies, supportive therapies) applied as part of comprehensive cardiac rehabilitation programs. The purposes of psychological interventions are to (1) screen psychological predictors of risk, such as anxiety, depression; (2) facilitate a return to normal living; (3) encourage patients to make lifestyle changes in order to prevent further events. A meta-analysis of 8,988 patients in 37 trials found that cardiac rehabilitation programs including psychological interventions resulted in a 34% reduction in cardiac mortality and a 29% reduction in recurrent MI at 1-10 years follow up.
Psychological interventions seem to be effective enhancing recovery rate. These findings emphasize the roll of psychologists in the prevention and rehabilitation of cardiac diseases.

Biography:

Margaret Kweku completed PhD in 2007 from the London School of Hygiene and Tropical Medicine (LSHTM) London UK. She is a senior Lecturer at the School of Public Health of the University of Health and Allied Sciences, Volta Region, Ho, Ghana. She has published more than 17 papers in reputed journals. She is currently involved in conduction field interventions trials and evaluation of health intervention programmes. She is also involved in drug and vaccine trials.

Abstract:

Background: Intermittent preventive treatment for malaria in children (IPTc) is a promising intervention to reduce the burden of malaria in sub-Saharan Africa. Artemisinin-based combinations are judged the best treatments for multi-drug resistance P. falciparum malaria. Some of these combinations could also be used for IPTc if they have some prophylactic effect. We investigated the therapeutic efficacy, tolerability and ease of administration of dihydroarthemisinin plus piperaquine (DHA+PQ) and artesunate plus sulfamethoxypyrazine plus pyrimethamine (Co-Arinate) compared with SP in asymptomatic malaria children. Methods: Five hundred and ninety (590) children aged 6 to 59 months with asymptomatic P. falciparum malaria were randomly allocated to the SP arm as single dose (n=150), Co-Arinate daily for three days (n=143), Co-Arinate 12-hourly for 24hours (n=149) and DHA+PQ daily for three days (n=148) arms. The children were followed up on post treatment days 1, 2, 3, 7, 14, 28, 42 and 63. Results: Day 42 PCR-uncorrected parasitological failure rate was higher in the SP arm than in the Co-Arinate daily, Co-Arinate 12-hourly and DHA+PQ arms [40.0% vs. 26.6%; RR 0.7; 95% CI: 0.54, 0.95; p= 0.015], [40 vs. 34.9%; RR 0.9; 95% CI: 0.70, 1.14; p=0.362] and [40% vs. 16.2% RR 0.5; 95% CI: 0.35, 0.70; p<0.000]. The difference was statistically significant in the Co-Arinate daily and DHA+PQ arms but not in the Co-Arinate 12-hourly arm. Co-Arinate daily reduced the incidence of malaria by 41.5% (95% CI: 15.3%, 59.5%; p=0.004), Co-Arinate 12-hourly by 10.3% (95% CI: -25.0%, 35.6%; p=0.521) and DHA+PQ by 61.1% (95% CI: 41.0%, 74.4%; p<0.000) compared to SP. Interpretation: Three days dose regimens are safer, more efficacious and provide longer protection compared to single dose or divided doses administered within 24 hours. Therefore, DHA+PQ and Co-Arinate daily for three days can be used for IPTc in Ghana.

Biography:

Arun Aggarwal received his Ph.D. in 2004 from the University of Sydney. He is currently working as a Visiting Neurologist at Concord Hhospital, a Chronic Pain Specialist at the RPAH Pain Clinic and a Rehabilitation Specialist at Balmain hospital. He is a member of the Royal Australasian College of Physicians, Australasian Faculty of Rehabilitation Medicine and the Australasian Faculty of Pain Medicine. His research has included Electrophysiological Studies in Familial Amyotrophic Lateral Sclerosis with his primary paper, “Detection of pre-clinical motor neuron loss in SOD1 mutation carriers using motor unit number estimation” being widely cited in the international literature. He was awarded the Australian Association of Neurologists Young Investigator Award for his presentation of this paper in 1999 and was nominated for the Delsys Prize in 2012. He has written 3 book chapters on this subject and has also published widely on a number of different topics. He currently has a number of research projects in the areas of Chronic Pain and Parkinson ’s disease. He is on the Editorial board of the Journal of Clinical Trials. He is the current Chairman of Australian & NZ Association of Neurologists Neuro-Rehabilitation Sub-Committee and on the Medical Advisory Board of Trigeminal Neuralgia Association (Australia).

Abstract:

Background: Ketamine is a non-competitive antagonist of N-Methyl-D- Aspertate (NMDA) receptors. It reduces NMDA-mediated nociceptive responses in dorsal horn neurons by binding to the phencyclidine (PCP) site of the NMDA receptor-gated ion channel. Chronic noxious input to the dorsal horn cells (mediated mainly by C-fibres) results in the removal of magnesium from the NDMA receptors and their activation by glutamate. This causes prolonged depolarization spinal neurons, which leads to central desensitization that may result in hyperalgesia (an excessive response to a painful stimulus and allodynia (a painful response to a normally non-painful stimulus). Ketamine helps to minimise excessively painful responses. Studies have also proven that antagonizing these receptors improves opioid receptors sensitivity, reduces opioid tolerance and suppresses opioid-induced hyperalgesia. Currently, there is no evidence on the long-term effectiveness of ketamine infusions in the setting of chronic pain.
Methodology: We performed a prospective study on 100 patients in the RPAH Pain Management Centre, to evaluate the long-term effect of a 3-7 day sub-anesthetics ketamine infusion with refractory chronic, non-cancer between 2007 and 2012. A proportion of patients who responded to the infusion were commenced on lozenges to see if the improvement could be maintained. The assessment was based on the evaluation of a standardized questionnaire performed over a telephone conversation. We sought to determine whether ketamine provides long-term benefit to:
-Reduce pain levels
-Reduce opioid requirements
Results: Our study showed that there was a significant reduction in pain intensity measured by VAS reducing from a mean of 6.38 before ketamine to 4.60 after ketamine infusion (p<0.005). There was also a significant reduction in opioid use from a mean morphine equivalent dose of 216 mg/day before ketamine to 89 mg/day after ketamine infusion (p<0.005). Current preliminary data suggests that around 35% of patients are able to maintain these opioid dose reductions with similar or reduced VAS scores, when placed on ketamine lozenges. This study answers several unresolved issues regarding the ketamine infusion. The most clinically important is whether it will be possible to maintain the ketamine induced pain relief for long-term, what the percentage of relapse is and what the response to ketamine lozenges is after a ketamine inpatient infusion.
Conclusion: The preliminary results of this prospective study suggest that a sub-anesthetic inpatient infusion of ketamine may offer a promising therapeutic option for long-term relief of chronic refractory non-cancer pain. The study also establishes the safety and efficacy of this novel approach and strongly supports ketamine being a useful and safe long-term analgesic option.

Biography:

Abstract:

In response to an increase in conduction of clinical trials, Egypt has established many research ethics committees (RECs) during the last few years. Egyptian Ministry of health established REC since 2007 and it has been acting since this time to review all clinical trials undertaken in Egypt in addition to all Master and Doctorate theses conducted in the governmental hospitals. This REC has created its own Standard Operating Procedures (SOPs) as well all the guidelines needed to be followed by the Egyptian researchers in their submission to the REC. In addition the ministry initiated a project to create "clinicaltrial.mohp.gov.eg" to register all the clinical trials conducted in Egypt. In order to control and supervise the Contract research organizations (CRO’s), we register all the CRO’s acting in Egypt. The total number of CRO’s registered in MOH till date are 16, the first CRO was registered in 2013. Although we are doing a lot of effort still many steps has to be taken to reach the standard we are aiming to: we undergo many training courses in the fields of research ethics, good clinical practice, research methodology and biostatistics to build the capacities of our health researchers to be able to conduct more clinical trials and to have Egypt as an attracting sites for them. We aim to have several clinical research centers with the needed qualified staff to conduct such trials.

Biography:

Dr. Jules Clement Nguedia Assob completed his PhD in Medical Biochemistry at the age of 31 years from the University of Yaoundé I in Cameroon. He is the Head of Department of Medical Laboratory Sciences of the Faculty of Health Sciences at the University of Buea. He has published over 70 papers in reputed journals and serving as Editorial Board member in many journals. He is the Treasurer of the Cameroon Society for Toxicological Sciences and a fellow of the International Foundation for Sciences since 2007. His fields of research are: Chemotherapy of infectious diseases; clinical biochemistry and Public health.

Abstract:

Clinical trials are experiments done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. Clinical trials are usually done on single products like antibiotics and antiretroviral drugs ; the combination of drugs in several therapeutics protocols like in Highly Active Anti-Retroviral drugs; anti-tuberculosis regimens and in the treatment of pathologies due to multidrug resistance germs are not usually considered. Various studies have shown that although individual compounds proven to be safe at clinical trials level tend to present adverse effects when introduce in therapeutic regimens involving more than one drug. The rationalization of the new strategies, however, requires great efforts in: standardization of mono- and multi-drugs preparations using all available high-tech methods. This paper presents present results of our various works on the “Incidence and Risk Factors of Anti-tuberculosis Drugs Induced Hepatotoxicity in HIV/AIDS Patients” and “on the “Variation of CD4+T-Lymphocyte Counts and Transaminases in HIV and HIV/HBV Co-infected Patients” advocating for prior clinical trials in similar diseases conditions.

Biography:

Abbas Alnaji was born in Baghdad 1962 and he had the Degree in Neurosurgery FICMS NS from University of Baghdad 1999. He is interested in research work and has eleven papers published in the field of surgical pathology causations.

Abstract:

Illnesses treated symptomatically had got causes! categorizing them as of not known etiology is for a while! One of the main pillars to disclose these causes is the clinical trial treatment CTT; it may exceed the other means, where it works when they are depleted. CTT has its civilization to be applied. It is the link among philosophy, clinical practice and applied sciences. Starts by looking for the truth, maintained by the perseverance and end by the smart perception. A wise man once said ‘’ the admiration prevents from increment’’ this is the philosophy. It refers to the satisfaction in what if we are on, will stop further discovery of diseases causation. The route is paved with difficulties, so needs insistence. Results of CTT are the meticulous harvest of each step of the route. For that, in my career, by applying the above three basis, I can say, good gain was obtained through; chronic low back pain, carpal tunnel syndrome, MRI signs had been satisfactorily knew their reality. and several others will be discussed in more reality in near future, the ignition for that was the clinical trials.

Biography:

Abstract:

Soya bean meal (SMB) and Soya bean protein lsolate (SOPI) were prepared from soya bean seeds. Based on the crude protein content, infant weaner foods was formulated on the substitution of SMB with SOPI and compared with three different commercial infant brand CFF, CFN and CFC, using weight gain, food conversion efficiency, relative organ weight and blood (haematological) constituents as response criteria. The result showed that 100% substitution of SMB with SOPI had the highest crude protein 16.6±0.1 g/100 g dry matter (DM), while among the commercial weaner foods CFC had the highest 16.2±0.1g/100 g DM. Infant weaner formulation of SMB or SPOI showed highest growth rate of 3.4±0.2 g/rat/day, was in the rats fed diet in which 75%of dietary SMB was replaced with SOPI. The least growth (1.1±0.2 g/rat/day) was in the rat fed commercial foods coded CFN or CFF. The relative organ weight (g/kg body weight) of the liver, kidney, spleen and heart of the rats were within normal ranges irrespective of whether they are fed SMB/SOPI or commercial foods. Haematological assessment showed no significant differences (p≥ 0.05) between the rat fed SMB/SPOI based diets and commercial brands with regards to the packed cell volume (PCV), red blood cell (RBC), white blood cell (WBC) and haemoglobin concentration (Hbc). Gross pathological observation of organs using such vital signs as colour, size, edge, and lesions revealed no abnormalities when compared with the controls.

Biography:

Abstract:

Thiamine deficiency has been documented to be prevalent in patients with diabetes mellitus, and correction of thiamine deficiency in this population may provide beneficial effects in the improvement of several cardiometabolic parameters, including prevention of impending complications secondary to chronic hyperglycemia. In this interventional study, we aim to determine whether thiamine supplementation is associated with cardiometabolic improvements in patients with diabetes mellitus type 2 (DMT2). A total of 86subjects (60 DMT2 and 26 age- and BMI-matched controls) were included and were given thiamine supplements (100mg/day) for 6 months. Anthropometrics and metabolic profiles were measured routinely. Serum thiamine and its derivatives were measured using high performance liquid chromatography. In all groups there was a significant decrease in total cholesterol after 3 months (p = 0.03) as well as HDL-cholesterol after 6 month thiamine supplementation (p = 0.009). Significant improvements were also observed in the mean serum levels of creatinine (p = 0.001), as well as thiamine and its derivatives in both serum and urinary thiamine levels across follow-up visits (p-values 0.002 and < 0.001, respectively). In the DMT2 group, improvements were observed in lipid profile [mean serum LDL- and total cholesterol with p-values 0.008 and 0.006, respectively], serum thiamine (p < 0.001), TMP (p < 0.001), TDP (p < 0.001), urinary thiamine (p < 0.001) and serum creatinine (p < 0.001). Thiamine supplementation is a promising adjuvant therapy for patients with DMT2. Longer clinical trials are needed to determine its protective effect in DMT2 complications.