What is the purpose of the South Asian Database of Controlled Clinical Trials (SADCCT)?
The SADCCT aims to: Provide a comprehensive source in the public domain of all controlled clinical interventional trials involving humans conducted in the listed South Asian countries • Contribute information about these trials to the Cochrane Central Register of Controlled Clinical Trials (CENTRAL), the largest collection of clinical trials in the world that is published in The Cochrane Library • Make information about clinical trials done in the listed South Asian countries available to those undertaking systematic reviews and meta-analyses of health care interventions and developers of evidence-based treatment guidelines • Reduce unnecessary effort in identifying clinical trials done in the listed South Asian countries • Contribute to evidence-based treatment, practice, and health care.
Why is the SADCCT important?
The SADCCT will provide information about clinical trials done in the listed South Asian countries that may otherwise not be readily available. Many journals from the region are not indexed in PubMed or other international databases that are commonly searched. Locating these non-indexed journals is time consuming and finding the relevant clinical trials provides additional difficulties. Authors of systematic reviews and developers of treatment guidelines may not be easily able to locate these trials and their exclusion from consideration and inclusion in the evidence base creates the possibility of biased and unreliable results and results that may not be applicable to health care in the region.
What is the difference between the SADCCT and the Indian Medlars Centre?
The Indian Medlars Centre is a bibliographic database of Indian biomedical journals maintained by the National Informatics Centre and the ICMR, and MedInd provides a one point resource of searchable full text contents of 38 peer reviewed Indian biomedical journals. The SADCCT is restricted to only providing limited information about controlled clinical trials and their sources, not about other types of research, but includes many more journals and sources of trials and covers countries in South Asia other than India.
What is the difference between trials in the SADCCT and the Clinical Trials Registry- India?
The Clinical Trials Registry-India (CTRI) is a source of information about interventional clinical trials in humans involving participants in India that are being planned (or are ongoing but not completed at the time of registration) and that are prospectively registered and made available in the public domain. The CTRI is a Primary Register of the WHO International Clinical Trials Registry Platform (WHO-ICTRP) that, together with the International Committee of Medical Journal Editors (ICMJE) and many other organizations and individuals, are attempting to ensure that a complete record of research on clinical interventions is accessible to all those involved in health care decision making, in order to improve research transparency and ultimately strengthen the validity and value of the scientific evidence base. The prospective registration of clinical trials is considered an ethical and scientific imperative by the WHO and many other organizations and countries worldwide. Clause 19 of the revised Declaration of Helsinki, released in October 2008, now states that "Every clinical trial must be registered in a publicly accessible data base before recruitment of the first subject." The ICMR and the Drug Controller General of India have also endorsed prospective trials registration in the CTRI of all interventional trials done in humans in India. The editors of many Indian medical journals have also endorsed the need for prospective trials registration as a pre-requisite for submitting manuscripts of trial reports for publication. The SADCCT contains information about interventional clinical trials in countries in South Asia that have been completed (or are in progress but have interim or follow up results). The SADCCT will provide complementary regional efforts to those of the CTRI and the WHO-ICTRP, and the Cochrane Collaboration, in ensuring that that all the evidence from clinical trials are made publically available to inform evidence-based practice and health care.
What are the sources of trials in the SADCCT?
The SADCCT is currently in a continual process of development and evolution. It will ultimately contain records of trials retrieved by careful searching for all journals published in the countries listed, that publish the protocols and/or results of clinical trials; and checking each available issue of each journal (online and print versions) from the internet or from library holdings for controlled clinical trials in humans. In addition, it will contain records of trials obtained from searching conference proceedings, dissertations, and other unpublished sources. Records from the listed countries are also obtained by searching Pubmed To begin with, 55 Indian biomedical journals (See list) are being regularly searched and the identified trials transferred to CENTRAL. This list will be expanded rapidly to include other journals from India and from other listed countries in the region and from other sources.
What additional input is provided to the identified trial records before inclusion in the SADCCT?
Each potential trial record is scrutinised by Centre staff to ensure that it is a controlled clinical trial involving human participants for a health condition or to prevent a health-related disorder or condition or improve health that was conducted in any of the listed South Asian Countries.
What information is provided in the SADCCT?
The SADCCT currently provides information about the title, authors and contact details, source of report, and country of the trial; publication details including journal or other citation and web address (if available); type of trial (controlled clinical trial or randomized controlled trial); and (if permission is granted) the abstract and key words (if available). The SADCCT currently only contains records of trials with two or more groups of participants allotted to interventions by random allocation or an allocation procedure that is not randomized. Hence the SADCCT does not usually contain records of trials without a control group and will not have records of phase I or many Phase II trials that have only one interventional arm. Wherever possible, the SADCCT will provide links to the original article (if available) from which the full text article may be obtained, provided the journal is open access or one has a subscription or other provision to access the article. The SADCCT does not provide electronic or hard copies of full texts of the articles. These records are downloaded into reference manager software (EndNote) and formatted. Trials are coded as RCT (if the abstract or full text reports that participants were allocated using some form of randomization; note: some of these records may not be properly randomized even if coded as RCTs since allocation may not have been concealed adequately); or CCT (controlled clinical trials if allocation is not mentioned as randomized). All records are then imported into MeerKat (an MS-Access relational database developed by Update Software for the Cochrane Collaboration) and duplicate records identified. Web-links are double checked before the database is uploaded into the public domain.
How can one locate trials in the SADCCT?
At present, a simple search function is provided that will search the database using free-text terms. The SADCCT is a searchable database that will, when fully developed, will have the functionality of similar databases and clinical trials registers.
How often will the SADCCT be updated?
Trial records will up-dated and made available in SADCCT on the 1st of each month. Trial records will be uploaded into CENTRAL every quarter . Disclaimer Contents This database is meant for research purposes only. While every attempt is made to ensure the accuracy of the contents of the SADCCT, the South Asian Cochrane Network & Centre, The Christian Medical College, Vellore, the ICMR and no one associated with this database can be held liable for inaccuracies in the information provided and in no case will be held responsible for decisions made based on the information found in this site. Decisions regarding your health should always involve the assistance of a trusted health care practitioner. The information provided in each report is the property of the publisher of the journal/author(s) of the trial. You are requested to directly contact authors/publishers for any clarifications or comments/feedback. External Links Although each external link on the SADCCT website has been carefully selected, the SADCCT does not (nor does anyone associated with this database) take any responsibility for the content of websites to which the SADCCT website links or failure of web-links. If you discover a link that does not work, please contact us. If or have any other concerns that have not been addressed by the above information, please contact The South Asian Cochrane Network and Centre at:firstname.lastname@example.org