A comparison of regulatory approval of clinical trial protocol with different countries

<p class="abstract">In present scenario, different countries must follow different regulatory requirements for protocol approval process of new drug application. Present study, we studied the regulatory requirements, timelines of approval and guidelines according to central drug standard control organization (CDSCO), therapeutic goods administration (TGA), food and drug administration (FDA) and European medical agency (EMA). The objective was to compare the regulatory approval of clinical trial protocol process. A comparative observational study was undertaken among the clinical trials and regulatory bodies of India (CDSCO), Australia (TGA), US (USFDA), Europe (EMA). The study specified various regulatory guidelines and safety requirements for conduct and inspection of clinical trial. Clinical trial protocol guidelines the essential documents are determined, and various timelines are being identified. And compared with the fees with other countries. Indian payments were compared with other countries. Timelines with safety reporting were compared with other 3 countries (Europe, Australia and US). The regulatory guidelines in the clinical trial different between countries. There is different timelines and requirements of clinical trial application approval process for each regulatory body. This study methodology has enabled comparisons to be made both within agencies and between different authorities and has identified differences in the timelines that applications spend in different stages of the review.</p><p> </p>

Ethical and procedural issues for applying researcher-driven multi-national paediatric clinical trials in and outside the European Union: the challenging experience of the DEEP project

Background We describe our experience from a multi-national application of a European Union-funded research-driven paediatric trial (DEEP-2, EudraCT 2012-000353-31; NCT01825512). This paper aims to evaluate the impact of the local and national rules on the trial authorisation process in European and non-European countries. National/local provisions and procedures, number of Ethics Committees and Competent Authorities to be addressed, documentation required, special provisions for the paediatric population, timelines for completing the authorisation process and queries received were collected; compliance with the European provisions were evaluated. Descriptive analysis, Wilcoxon Rank-Sum test and General Linear Model analysis were used to determine factors potentially influencing the timelines. The Cluster Analysis procedure was used to identify homogenous groups of cases. Result The authorisation process was completed in 7.7 to 53.8 months in European countries and in 17.1 to 27.1 months in non-European countries. The main factors influencing these timelines were the requests for changes/clarifications in European countries and the different national legislations in non-European countries. Conclusion This work confirms that the procedures and requirements for the clinical trial application of a paediatric trial are different. In the European Union, the timeframes for submission were generally harmonised but longer. In non-European countries, delays were caused by national dispositions but the entire authorisation process resulted faster with less requests from ECs/CAs. The upcoming application of Regulation (EU) 536/2014 is expected to harmonise practices in Europe and possibly outside. Networks on paediatric research acting at international level will be crucial in this effort.

Pre-clinical study of IRDye800CW-nimotuzumab formulation, stability, pharmacokinetics, and safety

Background Epidermal growth factor receptor (EGFR) is a target for cancer therapy as it is overexpressed in a wide variety of cancers. Therapeutic antibodies that bind EGFR are being evaluated in clinical trials as imaging agents for positron emission tomography and image-guided surgery. However, some of these antibodies have safety concerns such as infusion reactions, limiting their use in imaging applications. Nimotuzumab is a therapeutic monoclonal antibody that is specific for EGFR and has been used as a therapy in a number of countries. Methods Formulation of IRDye800CW-nimotuzumab for a clinical trial application was prepared. The physical, chemical, and pharmaceutical properties were tested to develop the specifications to determine stability of the product. The acute and delayed toxicities were tested and IRDye800CW-nimotuzumab was determined to be non-toxic. Non-compartmental pharmacokinetics analysis was used to determine the half-life of IRDye800CW-nimotuzumab. Results IRDye800CW-nimotuzumab was determined to be non-toxic from the acute and delayed toxicity study. The half-life of IRDye800CW-nimotuzumab was determined to be 38 ± 1.5 h. A bi-exponential analysis was also used which gave a t1/2 alpha of 1.5 h and t1/2 beta of 40.8 h. Conclusions Here, we show preclinical studies demonstrating that nimotuzumab conjugated to IRDye800CW is safe and does not exhibit toxicities commonly associated with EGFR targeting antibodies.

Ethical and Procedural Issues For Applying Researcher-Driven Multi-National Paediatric Clinical Trials in and Outside The European Union: The Challenging Experience of The DEEP Project

Background. We describe our experience from a multi-national application of a European Union-funded research-driven paediatric trial (DEEP-2, EudraCT 2012-000353-31; NCT01825512).This paper aims to evaluate the impact of the local and national rules on the trial authorisation process in European and non-European countries. National/local provisions and procedures, number of Ethics Committees and Competent Authorities to be addressed, documentation required, special provisions for the paediatric population, timelines for completing the authorisation process and queries received were collected; compliance with the European provisions were evaluated.Descriptive analysis, Wilcoxon Rank-Sum test and General Linear Model analysis were used to determine factors potentially influencing the timelines. The Cluster Analysis procedure was used to identify homogenous groups of cases.Result. The authorisation process was completed in 7,7 to 53,8 months in European countries and in 17,1 to 27,1 months in non-European countries. The main factors influencing these timelines resulted the requests for changes/clarifications in European countries and the different national legislations in non-European countries.Conclusion. This work confirms that the procedures and requirements for the clinical trial application of a paediatric trial are different. In the European Union, the timeframes for submission were generally harmonised but longer. In non-EU countries, delays were caused by national dispositions but the entire authorisation process resulted faster with less requests from ECs/CAs. The upcoming application of Regulation (EU) 536/2014 is expected to harmonise practices in Europe and possibly outside. Networks on paediatric research acting at international level will be crucial in this effort.

EYE ON CHINA

Prof. Tu Youyou receives 2015 Warren Alpert Foundation Prize China Biologic announced Pricing of Public Offering of Common Stock CASI Files new Drug Clinical Trial Application with China FDA to expand U.S Development of ENMD–2076 in Fibrolamellar Carcinoma Cleantech Solutions International to Showcase New Air-fluid, Dual-use Dyeing Machines at ShanghaiTex 2015 Pfizer Consumer Healthcare to Expand Caltrate and Centrum Production in China Huazhang Technology Entered into Letter of Intent in Relation to Possible Acquisition of the Construction of Wastewater Treatment Projects in the PRC MERS-CoV Antibodies and Polypeptide identified by Researchers in Fudan University: m336 & HR2P-M2 Ecolab acquires Water Treatment Provider in China 2nd Guangdong-Canada Biological Psychiatry Symposium held in Shantou Guangdong Technion-Israel Institute of Technology a new Learning and Research Project approved by the Ministry of Education The Sixth China Cell Therapy Conference, 2015

CLINICAL TRIAL IN INDIA: RISE AND FALL

Fight with the disease is the ever evolving frontier for human beings. Discovery of new drugs and devices throughclinical research are the armory to help in the fight with the affliction of mankind. Clinical trials, test potentialtreatments in human volunteers to see whether they should be approved for wider use in the general population. Atreatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy. India stoodas a global hub for clinical trials in past years. Later, the amendments made in Indian regulations paved for the declineof clinical trials. The aim of this article is to provide the details about the Indian clinical trial application filingprocess, the amendments made in its regulations and the challenges faced by Indian clinical trial industry.