CLINICAL TRIALS REGISTRY-INDIA.pptx

The mission of the Clinical Trials Registry-India (CTRI) is to ensure that all clinical trials conducted in India are prospectively registered, i.e. before the enrolment of the first participant. Additionally, post-marketing surveillance studies, BA/BE studies as well as clinical studies as part of PG thesis are also expected to be registered in the CTRI. The vision of the CTRI is to ensure that every clinical trial conducted in the region is prospectively registered with full disclosure of the trial data set items. While this register is meant primarily for trials conducted in India, the CTRI will also accept registration of trials conducted in other countries in the region, which do not have a Primary Registry of its own, provided ethics approval (in English) is available and the study has not begun enrolling. The Clinical Trials Registry- India (CTRI), hosted at the ICMR's National Institute of Medical Statistics (http://icmr-nims.nic.in), is a free and online public record system for registration of clinical trials being conducted in India that was launched on 20th July 2007 (www.ctri.nic.in). Initiated as a voluntary measure, since 15th June 2009, trial registration in the CTRI has been made mandatory by the Drugs Controller General (India) (DCGI) (www.cdsco.nic.in). Moreover, Editors of Biomedical Journals of 11 major journals of India declared that only registered trials would be considered for publication1, 2.

Today, any researcher who plans to conduct a trial involving human participants, of any intervention such as drugs, surgical procedures, preventive measures, lifestyle modifications, devices, educational or behavioral treatment, rehabilitation strategies as well as trials being conducted in the purview of the Department of AYUSH (http://indianmedicine.nic.in/) is expected to register the trial in the CTRI before enrollment of the first participant. Trial registration involves public declaration and identification of trial investigators, sponsors, interventions, patient population etc before the enrollment of the first patient. Submission of Ethics approval and DCGI approval (if applicable) is essential for trial registration in the CTRI. Multi-country trials, where India is a participating country, which have been registered in an international registry, are also expected to be registered in the CTRI. In the CTRI, details of Indian investigators, trial sites, Indian target sample size and date of enrollment are captured. After a trial is registered, trialists are expected to regularly update the trial status or other aspects as the case may be. After a trial is registered, all updates and changes will be recorded and available for public display.
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1. CLINICAL TRIALS REGISTRY-INDIA Manasi dhamal Akshata chandak Aarti yadgire

2. OVERVIEW Siro Clinical Reaserch Institute www.siroinstitute.com

3. CLINICAL RESEARCH Clinical research is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease . Siro Clinical Reaserch Institute www.siroinstitute.com

4. CLINICAL TRIAL Siro Clinical Reaserch Institute www.siroinstitute.com Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy is known as Clinical Trial.

5. PHASES IN CLINICAL TRIALS Siro Clinical Reaserch Institute www.siroinstitute.com

6. CLINICAL TRIALS REGISTRY-INDIA (CTRI) The Clinical Trial Registry of India ( CTRI ) – is an online system developed by National Institute of Medical Statistics , under Indian Council for Medical Research (ICMR), New Delhi . The Clinical Trials Registry – India (CTRI), is a free, searchable online platform for registration of clinical trials being conducted in India and as well as countries which do not have a Primary Registry of their own. The registered trials are freely searchable not only through CTRI but also from the International Clinical Trials Registry Platform (ICTRP). At present the Government of India has made registration of Clinical trials in this CTRI registry as mandatory and is notified by Drug Controller General of India (DCGI). Siro Clinical Reaserch Institute www.siroinstitute.com

7. INTRODUCTION The Clinical Trials Registry – India (CTRI) is a free, online platform ( www.ctri.nic.in ) for registering clinical trials being conducted in India and countries which do not have a Primary Registry of their own. From its inconspicuous and humble beginnings on July 20, 2007, with just 11 trials registered in the first 6 months, after a decade, the CTRI now has >12,000 trials registered. Currently, the CTRI registers all types of clinical studies including interventional trials (73%) , observational (24%) , bioavailability/bioequivalence , and post marketing surveillance studies (3%) . All registered trials are freely searchable and viewable by the public from the CTRI homepage using appropriate and relevant keywords. In 2005, the International Committee of Medical Journal Editors took the lead in listing minimum requirements for protocol-related data to be published in publicly available registries before trial initiation, without which manuscripts would not be considered for publication. Apart from transparency, setting up of the CTRI is expected to help remove publication bias by bringing in all the trial results, positive or negative, in the public domain and also prevent duplicate research  Siro Clinical Reaserch Institute www.siroinstitute.com

8. HISTORY The CTRI, an online trial registry portal, was launched on July 20, 2007 . The CTRI is hosted and managed by ICMR-National Institute of Medical Statistics, New Delhi . In February 2008 , editors of 11 Indian biomedical journals came out in support of clinical trial registration. They published a joint statement stating their support for trial registration with a pledge not to accept any unregistered clinical trial for publication in their journal from 2010 onward. In December 2008 ,the World Health Organization (WHO) recognized CTRI as a Primary Registry and since then, every month, data from the CTRI is transferred to the International Clinical Trials Registry Platform, which is a one-stop portal for all registered clinical trials being conducted all over in the world. The CTRI continued to actively promote and advocate prospective trial registration and made specific efforts to rope in major stakeholders. These efforts paid off and in 2009, the Central Drugs Standard Control Organization (CDSCO) gave a major boost to the mission of CTRI by making it mandatory for all regulatory trials to be prospectively registered in the CTRI. Siro Clinical Reaserch Institute www.siroinstitute.com

9. HISTORY The CTRI software was upgraded and the revised software application with its previously registered data intact was implemented on March 15, 2011 . The new application helped CTRI become an entirely paperless portal as electronic copies of ethics and regulatory approvals could be uploaded into the system. Further, the revised software included more drop-down options, better search as well as audit trail facilities. The CTRI organized a series of workshops , including that for ethics committee members , to garner their support for trial registration. This further enhanced trial registration in CTRI, as several ethics committees made trial registration mandatory. In addition, as a direct result of CTRI advocacy efforts, AYUSH (Ayurveda, Yoga, Unani, Siddha, and Homeopathy) studies were also brought under the umbrella of registration. In 2015, an e-tutorial of the CTRI was launched . This tutorial guides the interested stakeholder through the entire process of trial registration and search facilities offered by the CTRI. Siro Clinical Reaserch Institute www.siroinstitute.com

10. OBJECTIVE, MISSION & VISION OF CTRI Objective of CTRI: The main objective of this CTRI is to ensure transparency, accountability and accessibility of all the clinical trials that are being conducted in India. Mission of CTRI: The mission of CTRI is to encourage all clinical trials conducted in India to be prospectively registered. i.e. before the enrollment of first participant. Vision of CTRI: The vision of CTRI is to ensure every clinical trial conducted in the region is prospectively registered with full disclosure of the trial data set times. Though this register is primarily meant for trials conducted in India, the CTRI will also accept registration of trials conducted in other countries in the region, which do not have a primary registry of its own. Siro Clinical Reaserch Institute www.siroinstitute.com

11. Why is Trial Registration Important? Prevent selective reporting and publication of positive results Prevent unnecessary duplication of research efforts Empower patients and the public about planned or ongoing trials and if necessary enroll in them. Give ethics committees and researchers access to studies being conducted and compare them to research that is under their consideration or is being planned. Siro Clinical Reaserch Institute www.siroinstitute.com

12. Signatories to Joint Statement Indian Council of Medical Research (ICMR) Research Council of Norway UK Medical Research Council Medicines' Sans Frontier's Epicenters CEPI (Coalition for Epidemic Preparedness Innovations) PATH (Program for Appropriate Technology in Health) Institute Pasteur Bill and Melinda Gates Foundation Welcome Trust Siro Clinical Reaserch Institute www.siroinstitute.com

13. TYPES OF TRIAL REGISTRATION Siro Clinical Reaserch Institute www.siroinstitute.com

14. IMPACT OF CTRI Information base for stakeholders A learning tool Impact on ethics of research Siro Clinical Reaserch Institute www.siroinstitute.com

15. Financial support and sponsorship The CTRI has been set up with financial support from :- The Department of Science and Technology (DST) The Government of India (GOI) The Indian Council of Medical Research (ICMR) The Ministry of Health and Family Welfare (MOHFW) World Health Organization (WHO) New Delhi, India NOTE - No funding has been received for the preparation of this manuscript. Siro Clinical Reaserch Institute www.siroinstitute.com

16. How to Register a Trial? Trial registration in the CTRI is an online process and free of cost. The trial registration dataset of the CTRI is given in the below picture. Process of trial registration is discussed in detail in the E- tutorial on the home page of CTRI. Siro Clinical Reaserch Institute www.siroinstitute.com

17. REGISTRATION PROCESS (1/2) Public declaration and Identification of Trial Investigators Sponsor details Intervention details Study details like Method and conduct of Study, Population, Study Place, Health condition/problem studied, Study type Trial sites IEC/DCGI approval Outcome of the study Recruitment status of the trial Siro Clinical Reaserch Institute www.siroinstitute.com

18. REGISTRATION PROCESS (2/2) Brief summary Estimated duration of the trial Recruitment status of the trial After registration of a trial, the trial lists and changes are updated regularly and are recorded. The details are available for public display. Being a Primary Register of the International Clinical Trials Registry Platform (ICTRP) ( http://www.who.int/ictrp/search/en/ ), registered trials are freely searchable both from the WHO’s search portal, the ICTRP as well as from the CTRI ( www.ctri.nic.in ) Siro Clinical Reaserch Institute www.siroinstitute.com

19. Registration Data Set of the CTRI (1/4) Registration Number Trial Registration Date Public Title of Study* Scientific Title of Study Acronym, if any* Secondary IDs, (UTN, Protocol No etc.)* Principal Investigator’s Name and Address Contact Person (Scientific Query)* Contact Person (Public Query)* Source/s of Material or Monetary Support* Primary Sponsor* Siro Clinical Reaserch Institute www.siroinstitute.com

20. Registration Data Set of the CTRI (2/4) Secondary Sponsor* Countries of Recruitment* Site/s of study* Name of Ethics Committee and approval status* Regulatory Clearance obtained from DCGI* Health Condition/Problem studied* Study Type* Intervention and Comparator agent* Key inclusion/Exclusion Criteria* Method of generating randomization sequence Siro Clinical Reaserch Institute www.siroinstitute.com

21. Registration Data Set of the CTRI (3/4) Method of allocation concealment Blinding and masking Primary Outcome/s* Secondary Outcome/s* Target sample size* Phase of Trial* Date of first enrollment* Estimated duration of trial Status of Trial* Publication Siro Clinical Reaserch Institute www.siroinstitute.com

22. Registration Data Set of the CTRI (4/4) Brief Summary* Date of actual study completion Final enrolment number achieved. NOTE - Underlined items are assigned by the CTRI software upon trial registration. Items marked with an (*) are mandatory items i.e. without these items the trial will not be submitted Items in Black are WHO Data Set items . Items in Green are additional requirements in the CTRI . Items in Red are New Data Set Items for Completed /Terminated trial . Siro Clinical Reaserch Institute www.siroinstitute.com

23. How to use CTRI Website? www.ctri.nic.in ICTRP search portal (who.int) Siro Clinical Reaserch Institute www.siroinstitute.com

24. What is Trial Verification? An email is sent from CTRI to all contact persons mentioned in the trial registration form (except to the trial registrant). Once all the trial contact persons respond, trial verification process is considered complete. Siro Clinical Reaserch Institute www.siroinstitute.com

25. References https://www.researchgate.net/publication/324758508_CTRI_-_CLINICAL_TRIAL_REGISTRY_-_INDIA http://ctri.nic.in/Clinicaltrials/news/NewsBulletin_2017.pdf https://www.ijp-online.com/article.asp?issn=0253-7613;year=2018;volume=50;issue=4;spage=208;epage=211;aulast=Vardhana Siro Clinical Reaserch Institute www.siroinstitute.com

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