Clinical research Archives - Page 2 of 3

Ethics committees-clinical research

In India, The concept of ethics committees were in 1980 by ICMR. Indian council of medical research (ICMR) provided the guidelines for the formation of Ethics committee. Ethics committee (EC) formed as a group of members including medical or scientific professionals along with non-medical or non-scientific professionals/persons. EC can also be called as Review Board (RB). Ethics committee (EC) is designated for the purpose of protecting the rights, safety and well-being of the subjects (humans) participating in the clinical research. This board is responsible for reviewing and approving the clinical research study protocols or its amendments in an unbiased manner. No study will be conducted in humans anywhere in India without having prior Ethics committee approval.

Types of Ethics committees-clinical research:

Two types of Ethics Committees available in India. One is Institutional Ethics Committee, another one is Independent Ethics Committee. Sometimes both ethics committees written as “ICE” in the short form in India. But both ethics committees are completely different. Institutional Ethics Committee works similar to Institutional Review Board (IRB)in other countries.

Institutional Ethics Committee:

It is formed by a hospital/Research centre. It reviews the documents/protocols submitted by that institution for conducting clinical trials (BA/BE studies or Clinical trials). It provides an unbiased opinion/approval about the proposed study from the research subjects point of view. It also performs ongoing review of the approved study at regular time intervals. Ethics committee consist of minimum of seven members and maximum of 15 members including chairman and member secretary. Ethics committee chairman should be from outside the institution.

Apart from the Ethics committee members, subject experts can also be invited for the EC meetings for their advice but they won’t voting rights for taking the decision about the proposed study protocol. It is mandatory to obtain EC approval letter before initiating the study.

Independent Ethics Committees (IEC):

It is not a part of any institution or hospital or research centre. It is an independent body without having any relationship with the institution. It reviews the submitted protocols from institutions and give the approvals to conducting the studies. Most important point is, at present IEC can only give approvals to the Bio availability/ Bio equivalence (BA/BE) studies of approved drugs. Except from these two things, ICE will act as same as Institutional Ethics Committee.

At present, nearly 660 Ethics committees registered with Central Drugs Standard Control Organisation (CDSCO) in India. From this, approximately 530 are Institutional Ethics Committees and remaining (130) are Independent Ethics Committees.

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List of clinical trial registries:

Clinical trial registries list provided here with the website urls.

Clinical trial registry is an official website that allows us to registering the clinical trials. Any body can register the clinical trails in the registry who will sponsor the study or by any organisation who is conducting the study. Usually Pharmaceutical or medical or biotech companies or research institutes will register the trials in the clinical trial registries.

Two types of registries available. They are primary registry and partner registry.

Primary registry:

Primary registries are developed according to the specific criteria given by World Health Organisation (WHO) International Clinical trial registry platform (ICTRP) This specific criteria include these 6 categories. That is Content, quality &validity, Accessibility, Unambiguous Identification, Technical capacity, Administration &governance. Primary registry meets the requirements of International committee of medical journal editors (ICMJE). Registration of trial in the clinical trial primary registry in the WHO network or USA Clinical trial registry (Clinicaltrials.gov) is mandatory for publishing the study in international biomedical journals. ICMJE announced this statement 15 years back and applicable from July 1^st 2005 onwards. All these primary registries are linked to the WHO- ICTRP. ICTRP can directly receive the data from these primary registries.

Related: Clinical trials overview

A total number of 16 registries recognized as primary registries in the WHO registry network. Along with these 16 registries Clinical trials.gov (USA) recognized by ICMJE. Along with USA registry Clinicaltrials.gov, these 16 primary registries act as data providers to WHO. This data available in the WHO ICTRP search portal. WHO ICTRP search portal is technically not considered as a clinical trial registry.

For eg: If you register a clinical trial in any of these 17 clinical trial registries, you can find that trial in WHO ICTRP search portal. Registries registered trail data upload to ICTRP search portal periodically.

Australia, China, UN, EU, Netherlands, USA registries uploaded Friday of the every week. Remaining registries data uploaded monthly basis.Types of clinical trial registries

List of clinical trial registries recognized by WHO network and ICMJE are follows.

List of clinical trial registries (Primary)

1. Australian New Zealand CTR (ANZ Clinical Trial Registry) – http://www.anzctr.org.au

2. Brazilian CTR (ReBec) – http://www.ensaiosclinicos.gov.br/

3. Chinese CTR (ChiCTR) – http://www.chictr.org.cn/

4. Republic of korea Clinical Research Information Service (CRiS), – https://www.who.int/ictrp/network/cris2/en/

5. CTR – India (CTRI) – http://ctri.nic.in

6. Cuban Public Registry of Clinical Trials (RPCEC) – http://registroclinico.sld.cu/

7. European Union CTR (EU-CTR) – https://www.clinicaltrialsregister.eu/

8. German CTR (DRKS) – https://www.drks.de

9. Iranian Registry of Clinical Trials (IRCT) – https://www.irct.ir/

10. United Kingdom for International Standard Registered Clinical/soCial sTudy Number (ISRCTN) – http://www.isrctn.com/

11. Japan Primary Registries Network (JPRN) – http://rctportal.niph.go.jp/ (It has four networks JapicCTI, JMACCT CTR, jRCT, UMIN CTR )

12. Thai CTR (TCTR) – http://www.clinicaltrials.in.th/

13. The Netherlands National Trial Register (NTR) – https://www.trialregister.nl/

14. Pan African CTR (PACTR) – https://pactr.samrc.ac.za/

15. Peruvian CTR (REPEC) – https://ensayosclinicos-repec.ins.gob.pe

16. Sri Lanka CTR (SLCTR) – http://www.slctr.lk/

USA – https://clinicaltrials.gov/ (Recognised by ICMJE, It is not in the list of WHO registry network but act as data provider to WHO ICTRP)

WHO ICTRP- http://apps.who.int/trialsearch/ (Technically not called as a clinical trial register)

Partner registry:

Partner registries does not meet the requirements of ICMJE. But partner registry meets the WHO ICTRP specific criteria as mentioned above. They are affiliated to ICMJE registered primary registry or Primary registry in WHO network. It is the responsibility of primary registry to make sure that the partner registry meets the WHO registry criteria. ICTRP directly will not have access to receive the data from these partner registries. Along with 16 primary registries two partner registers available. These two registries are affiliated to Chinese clinical trial registry (ChiCTR). Partner registries can also be called as secondary registries. They are as follows.

Centre for Clinical Trials, CTR – Chinese University of Hong Kong – http://www2.ccrb.cuhk.edu.hk/web/
The Acupuncture-Moxibustion Clinical Trial Registry (AMCTR) Beijing
Apart from these registries, other available registries are as follows.

List of clinical trail registries (Regional)

Canadian cancer trials – http://www.canadiancancertrials.ca/ ( Canadian based cancer registry –Only for cancer clinical trails in Canada)
Health Canada Clinical Trial Database – http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdonclin/index-eng.php (It is technically not called as a registry)
Hong Kong University clinical trials registry (HKUCTR)- http://www.hkuctr.com/
Indonesia clinical trial registry- https://ina-registry.org/
NBScience Clinical trial registry (NBSCTR)- Ukraine – http://www.nbscience.com/
Philippine Health Research Registry (PHRR) – http://registry.healthresearch.ph
Swiss National Clinical Trials Portal (SNCTP) – http://www.kofam.ch/en/swiss -clinical-trials-portal.html
South African National Clinical Trial Register (SANCTR) – http://www.sanctr.gov.za/
Spanish registry of Clinical trials (REec) – https://reec.aemps.es
Tanzania Clinical Trial Registry (TzCTR) – http://www.tzctr.or.tz/

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