|Year : 2021 | Volume
| Issue : 2 | Page : 160-169
Current status of in silico, preclinical and clinical study registries across the globe: A systematic review and meta-analysis
Hardeep Kaur1, Phulen Sarma1, Manpreet Kaur2, Manisha2, Anusuya Bhattacharya3, Manisha Prajapat1, Subodh Kumar1, Ashutosh Singh1, Rahul Singh4, Harish Kumar1, Prasad Thota1, Ajay Prakash1, Bikash Medhi1
1 Department of Pharmacology, Postgraduate Institute of Medical Education and Research, Rishikesh, Uttarakhand, India
2 Department of Nursing, AIIMS, Rishikesh, Uttarakhand, India
3 Department of Ophthalmology, GMCH-32, Chandigarh, Rishikesh, Uttarakhand, India
4 Department of Gastroenterology, Postgraduate Institute of Medical Education and Research, Rishikesh, Uttarakhand, India
|Date of Submission||10-Nov-2020|
|Date of Decision||11-Mar-2021|
|Date of Acceptance||07-May-2021|
|Date of Web Publication||26-May-2021|
Dr. Bikash Medhi
Department of Pharmacology, Postgraduate Institute of Medical Education and Research, Chandigarh
Source of Support: None, Conflict of Interest: None
Introduction: Registration of study protocols brings about transparency and traceability and the amount of publication bias can be estimated. In this study, we have collected and presented data regarding clinical study registries, preclinical, in vitro and in silico study registries across the globe.
Materials AND METHODS: We searched via Google Search Engine with appropriate keywords e.g. name of country (n = 198), name of continent (n = 7), registry, study registry, animal, in silico, virtual, simulation, preclinical, animal, clinical trial. The overall pooled prevalence of clinical study registries and WHO primary registries in per continent was calculated using Medcalc software.
Results: The overall pooled prevalence of clinical study registries were 13% in each continent. The prevalence of WHO primary study registries were 8.9% of the countries per continent. Overall, there are 17 primary registries associated with WHO ICTRP as primary registries, 2 partner registries and 6 registries are affiliated to ICMJE. However, the amount of preclinical animal study registry was quite less (n = 4). Regarding in vitro studies, only country specific in vitro fertilization registries were available, however, in other research domains, registries were absent. Only one simulation study registry was available.
Conclusion: At priori study registration is essential to deal with selective reporting. Comparison between study protocol and final report allows us to know the protocol deviations and allows us to evaluate risk of bias and internal validity of the research findings. Although trialists are responsible for the completeness of records, yet the registries must have some measures for their periodic update and quality control of the data.
Keywords: Study registry, in silico, preclinical, clinical study
|How to cite this article:|
Kaur H, Sarma P, Kaur M, Manisha, Bhattacharya A, Prajapat M, Kumar S, Singh A, Singh R, Kumar H, Thota P, Prakash A, Medhi B. Current status of in silico, preclinical and clinical study registries across the globe: A systematic review and meta-analysis. Indian J Pharmacol 2021;53:160-9
|How to cite this URL:|
Kaur H, Sarma P, Kaur M, Manisha, Bhattacharya A, Prajapat M, Kumar S, Singh A, Singh R, Kumar H, Thota P, Prakash A, Medhi B. Current status of in silico, preclinical and clinical study registries across the globe: A systematic review and meta-analysis. Indian J Pharmacol [serial online] 2021 [cited 2021 Sep 23];53:160-9. Available from: https://www.ijp-online.com/text.asp?2021/53/2/160/316943
| » Introduction|| |
Registration of clinical trials is broadly considered as the scientific and ethical responsibility. Records of the registered trials serve as a resource for gaining insight into the field of health research and development. The notion of trial registration was initially revealed by Simes RJ in 1986. In 2008, as per review of Declaration of Helsinki, the WMA declared that “Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject.” PACTA, a WHO initiative aimed at helping the member countries for the development and harmonization of clinical trials at par with international standards. The group held its first meeting in November, 2010. Clinical trials have been described by the WHO as “any research study that allocates human beings or group of individuals to one or more health-related interventions to evaluate the consequences on health.” Clinical trials have immense potential to improve medicinal practice. Obligatory prospective registration of trials and open access to findings through databases are required to be initiated globally. It will not only allow independent appraisal of research data but also ensure an informed decision making in the medical field. US FDA Act, 2007 making clinical trials registration mandatory except phase 1 drug trials under Section 801, failing which not only the grant money will be lost but also penalty up to US$ 10 000 a day be imposed. For the meta-analysis, evidence-based medicine needs access to negative results to overcome the overestimation of positive results.
Need of study registry
Concealment, manipulation, and misinterpretation of clinical trial data eroded the confidence of the public in the past. Various attempts to achieve global registration of trials have not achieved much success probably because of a lack of stringent laws of enforcement. Under-reporting is research misconduct and may have serious consequences. It may lead to overestimation of treatment benefits or underestimation of their harmful effects, thereby putting the patients at risk and wastage of healthcare resources. However, the major concern is the protection of subjects participating in trials. Registration of trials not only provide access to favorable outcomes but also provide information on trials that have negative results or discontinued, thereby helping investigators having vested interest in research by enabling them to explore the clinical evidence to make informed decisions. It may help the patients to find trials for which they are eligible. It also helps in the planning and design of clinical trials and reduces publication bias. Registries facilitate the execution of systematic reviews and meta-analysis by helping in making an informed decision. Selective Outcome Reporting (SOR) and Selective Analysis Reporting (SAR) can significantly influence the direction, magnitude, and accuracy of pooled-effect estimates and inferences related to harms as well as benefits. Trial registration can not only reduce publication bias but also promote transparency. Public registration of trials is of fundamental importance for the integrity of the development process of medical devices. Apart from fulfilling the responsibilities toward the study participants, documentation of the trial outcomes offers the general public, the medical community as well as medical device manufacturers with more precise understanding on the usage of specific therapeutic devices.
Although there are many articles regarding different clinical study registries, a global evaluation of clinical, preclinical, in vitro and in silico studies are lacking. In this regard, this is the first systematic review and meta-analysis to address this issue.
| » Materials and Methods|| |
We searched google search engine with appropriate keywords, for example, name of the country (n = 198 countries), name of continent (n = 7), registry, study registry, animal, in silico, virtual, simulation, preclinical, animal, clinical, clinical trial. The registries were searched country-wise and continent-wise as well as according to various trial types including human, preclinical, in in vitro studies, and in silico.
Data extraction was done by two evaluators (HK and PS) independently and in case of any conflict BM was contacted and the issue was resolved.
As the result was dichotomous data, we presented the results in either descriptive format or in percentages. The pooled prevalence of clinical study registries and WHO primary registries per continent was calculated using random-effects model using Medcalc software.
| » Results|| |
The different types of components of the WHO registry network are shown in [Figure 1] and details of study registries are shown in [Figure 2]. The pooled prevalence of clinical study registry is 13% (95% confidence interval [CI] 6–21. Data are shown in [Figure 3]. The pooled prevalence of WHO primary registry is 8% (95% CI 4–14) per continent. Data are shown in [Figure 4]. Overall, there are 17 primary registries associated with WHO ICTRP as primary registries, 2 partner registries, and 6 registries are affiliated to ICMJE. However, the amount of preclinical animal study registry was quite less (n = 4). Regarding in vitro studies, only country specific in vitro fertilization registries were available, however, in other research domains, registries were absent. Only one simulation study registry was available. The details of all the clinical study registries are shown in [Table 1]. The details of preclinical/animal, in vitro, in silico and other study registries are shown in [Table 2] and [supplementary Table 1].
|Figure 3: Forest plot showing pooled prevalence of clinical study registries per continent|
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|Figure 4: Forest plot showing pooled prevalence of WHO primary registries per continent|
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|Table 2: Animal study registry, in vitro, in silico and other study registries|
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Clinical trial/clinical study registry
Out of the total of 27 registries screened; all the registries favored prospective registration of trials while the retrospective registration was allowed only 13 registries. While all 31 registries only register the trials involving human participants, only 15 registries prefer the registration of interventional trials and 11 registries also extended registration to register observational trials. Out of all registries screened 9 requires ethical approval before the registration of trial while 8 registries did not require registration for registering a trial. Out of seven continents, six continents have registries except Antarctica. Out of 49 countries (3 dependent) of Asia, 14 countries had registries. Apart from these, the clinical trial registry for Nepal is also under development by India. 0ut of 54 African countries, (4 dependent) 3 Countries had clinical trial registries. 3 out of 51 European countries (4 dependency) had individual trial registries. Further1 out of 23 and 2 out of 12 countries had individual trial registries for North America (with 22 dependencies) and South America (with 4 dependency) respectively. In the case of the Australian continent, consisting of 14 countries with 12 dependency or territories, only one clinical trial registry is available.
The WHO ICTRP launched in August 2005, consisting of Primary and Partner Registries; providing an international platform to enable researchers, health practitioners, journal editors consumers, and reporters to search regarding the information on clinical trials. It further includes data providers and registries working with ICTRP towards becoming primary registries. The aim was to create a single access point of information on clinical trials globally, but ICTRP being a voluntary system still faces the problem of compliance as far as registration of trials is concerned. A summit on health research was held in Mexico in November 2004 intended for the WHO to ensure the explicit identification of trials and facilitate the setting up of network of international clinical trial registries with solo point of access. The Data Set for trial registration consists of 24 items and requires separate registration of the public and scientific contact details.
It is the world's largest CTR launched by NIH in 1997 following FDAMA under Section-113 (FDAMA 113), a law passed by FDA requiring listing trials for conditions that are serious as well as life-threatening conditions. It was established by NIH and FDA together via NLM in 2000 and became functional by 2002. Initially, the registration was invited for trials for such conditions in Phase 2–4 for IND which was later extended to include phase 1 trials in 2007 after ICMJE extended its policy and broadened its definition to include all health-related interventions. Currently, it is the most widely used registry across the world. It represents 75% of the registrations of those available with WHO ICTRP. It accepts all research studies regardless of their study design related to human volunteers and meeting the criteria of ACT (Applicable Clinical Trial). It is mandatory to submit the trial results within 12 months following the primary date of completion. Although no retrospective registration is allowed, the principal investigator can submit the trial information within 21 days of enrolling the first patient. It does not accept animal studies.
Cuban public registry of clinical trials (RPCEC)
RPCEC is a bilingual registry, in Spanish and English, managed by CENCEC (National Center for Clinical Trials Coordination) in collaboration with INFOMED, backed by the Ministry of Sci. and Tech. of MINSAP. The registry was launched in the year 2007 and was recognized as the WHO primary registry in the year 2011. It offers both prospective and retrospective registration for interventional or observational trials. Ethical clearance is not required for registration in the registry.
CenterWatch was set up in 1994, a database that provides information about clinical trials to both researchers and patients. It also provides information regarding the trials in terms of patient recruitment and the site of trial conduction. Situated in Boston, it was one of the first internet sites to provide and publish information regarding active clinical trials to the patients. Here, patients can easily search information regarding ongoing trials in terms of location, disease type, recruitment status as well as details regarding sponsor, duration of trial, remuneration, etc. As compared to other databases that are more research-oriented CenterWatch is more towards being patient oriented.
The Peruvian Registry for Clinical Trials-REPEC is an online information system developed in 2007 by the National Institute of Health, a nonprofit organization. It is a prospective registry, of public access with an objective to provide information about the clinical trials that are being executed in Peru. The REPEC in turn contains the Registry of research centers, institutional committees of research ethics, sponsors, and research organizations by contract. It comprises a registry of clinical trials since 1995. The REPEC information fields meet the minimum requirements of the WHO trial record data set and are available in two versions: Spanish and English.
The Brazilian registry (ReBEC)
The registry became operational in December 2010 and incorporated as WHO ICTRP primary network in April 2011. It is multilingual, free open portal managed by Oswaldo Cruz Foundation. In association with the Cuban Public Clinical Trials Registry, it offers trial registration across Latin America and the Caribbean in languages such as Portuguese, Spanish, and English. It registers both experimental and nonexperimental trials on humans to be carried out in Brazil.
Clinical Trials Registry-India
The registry was launched on July 20, 2007, and was made obligatory by DCGI in June 2009. The registry is hosted by NIMS. It is free open-access portal funded jointly by ICMR, WHO, and Department of Science and Technology. Currently, it offers registration to all types of trials including observational, interventional, bioavailability/bioequivalence, or postmarketing surveillance studies. Prospective registration of trials has been made mandatory by DCGI.
Clinical trials in Japan
Japan owns “Japan Primary Registries Network (JPRN)” which is a network of three registries. The search portal for these registries is hosted by the JNIPH. The search portal is bilingual (both Japanese and English). The three registries are.
JMACCT is devoted for stimulating clinical trials in Japan founded in the year 2003. JMACCT is funded and supported by MHLW.
UMIN founded in the year 1989 was declared as acceptable registry by ICMJE in the year 2006. It serves as a database for the clinical and academic research being carried out in Japan. Other services offered by UMIN include serving as database for news, University hospital management and providing clinical and medical education. Registration of clinical trials requires user registration and it accepts all types of trials involving human be it interventional or observational. Although preference is given to prospective registration, it also accepts retrospective registration.
Japan Pharmaceutical Information Centre-Clinical Trials Information
Japan Pharmaceutical Information Centre-Clinical Trials Information was founded in July 2005 and it basically serves as a data provider. The site is available only in Japanese. It provides information about pharmaceutical literature and products pertaining to humans and animals.
Iranian Registry (IRCT)
IRCT was launched in the year 2008 and was incorporated as a part of the WHO primary registry network on December 4, 2008. The registry is backed by MOHME and hosted by IUMS (Iran University of Medical Sciences). It offers prospective as well as retrospective registration for interventional trials and also requires ethical approval for registration.
Thai Clinical Trials Registry
Thai Clinical Trials Registry (TCTR) was formed by university academicians in 2009 in compliance with the ICMJE declaration. It can be accessed via WHO ICTRP. The registry has been endorsed by the Ministry of Public Health since 2010 and funded by Thailand Centre of Excellence for Life Sciences, a self-governing organization founded in 2004 under the royal decree issued by the Thai government. The non-profit organizations Medical Research Foundation and CRCN provide core facilities, staff, and administrative support for TCTR. In order to minimize the publication bias and selective reporting, it only accepts the prospective registration of trials.
Clinical Research Information Service
Clinical Research Information Service is an online platform for the prospective registration of clinical trials to be conducted in Korea. It is backed by MOHW and started at KCDC (Korea Centre for Disease Control and Prevention). Registration of trials in Korea is recommended but not legally required. Being an 11th member of WHO ICTRP, it accepts the prospective registration of trials involving humans and is available publicly.
Sri Lanka Clinical Trials Registry
Sri Lanka Clinical Trials Registry is a nonprofit, Internet-based registry developed out of the efforts of the Sri Lanka Medical Association. It was launched in November 2006 and became the first Clinical trials registry of South Asia which was further incorporated as WHO primary registry in March 2008. It accepts only prospective registrations of clinical trials and does not offer retrospective registration of trials. Furthermore, registration of observational studies is also not allowed.
Chinese Clinical Trials Registry)
The registry was launched in October 2005, 1 week after the Indian Clinical Trial registry was launched and was incorporated as the primary registry of ICTRP in 2007. The registry accepts registrations from China and around the world. It requires registration to be done both in Chinese (Mandarin) and English. It emphasizes on the prospective registration of trials while retrospective registration is also accepted. It accepts both prospective and retrospective registration of clinical trials involving humans. However, the registration for prospective trials is free of charge while the retrospective registration requires payment of RMB 3000 CNY for the assessment and evaluation of data.
Acupuncture-Moxibustion Clinical Trial Registry
Acupuncture-Moxibustion Clinical Trial Registry is the partner registry of Chinese Clinical Trials Registry, launched in the year 2014 provides registration for acupuncture and moxibustion trials being conducted in all countries.
Philippine Health Research Registry
Philippine Health Research Registry is a database for clinical trials and health research being carried out in the country and is publicly accessible. The Department of Sci. and Tech. and the Philippine council for health research and Development jointly support the registry. It registers both clinical and nonclinical trials. It requires the research to be registered within 30 days of granting permission to conduct trials. Only Philippine nationals can upload and manage the information related to trials.
Lebanon Clinical Trials Registry
Lebanon Clinical Trials Registry is a trial registry owned by the Lebanon Ministry of Health, is a WHO primary registry aimed at the registration of trials involving human beings. It was officially recognized as the primary registry in July 2019. It allows only the prospective registration of trials. However, if provided a reasonable justification then the retrospective registration can also be accepted. It is mandatory to register all interventional trials while registration of observational studies is still mandatory.
European Union Clinical Trials Register
EMA manages the EudraCT, a database meant for the registration of trials. The trial results are available to the public via European Union Clinical Trials Register. It became WHO primary registry in September 2011. The registry is prone to selective bias as it does not provide information on various types of trials, for example, noninterventional trials, trials related to medical devices or surgical procedures, etc. The retrospective registration of trials is permitted only after discussion with the ethics committee with the national competent authorities.
German Clinical Trials Register (DRKS)
DRKS was launched in August 2008 and after 2 months, it became the part of WHO primary registry. The registry provides a bilingual platform to its users and is backed by the Federal Ministry of Health and Education. It accepts registrations for all kinds of trials (including interventional, observational, and prognostic studies). Although preference is given to the prospective registration, it also accepts the retrospective registration of ongoing and finished trials.
ISRCTN was launched in the year 2000 is an open-access peer-reviewed journal maintained by BioMed Central (publisher of Springer Science + Business Media). The abbreviation ISRCTN means “International Standard Registered Clinical/social study Number.” It is a part of BPG (Best Practice for Clinical Trials Registers) by the WHO. It offers registration of interventional as well as observational trials involving only humans. Being a part of Best Practice for Clinical Trials Registers (BPG) by the WHO, it promotes transparency in clinical research. It currently accepts both prospective as well as retrospective registrations. ISRCTN charges registration fee for the registration of trials. Although the emphasis is laid on the prospective registration of trials, the study can be registered at any stage.
The Netherlands Trial Register
The Netherlands Trial Register is an open access prospective trial register that registers the studies to be carried out in the Netherlands or by the Dutch researchers. It is a primary registry participating with the WHO and does not allow the retrospective registration of trials. However, it does require ethical approval for the registration process.
Swiss National Clinical Trials Portal
The Swiss National Clinical Trials Portal (SNCTP) is the portal where clinical trials in Switzerland are published. It contains data from two sources: from BASEC, the national platform for submitting applications for research projects to ethics committees, and from the ICTRP, which covers the 17 primary registries worldwide. The ICTRP clinical trials shown on the SNCTP are limited to those conducted in Switzerland; there is also an option to display trials conducted in one of Switzerland's neighboring countries.
Italian Registry of Clinical Trials
AIFA-IMA serves as a public repository of information related to clinical trials conducted on humans using medicines. Although it is a public portal, it is not operational since January 2013 due to some technical reasons.
Pan African Clinical Trials Registry
The ATM Registry founded in 2007 by the South African Cochrane Centre is a prospective trials registry. The registry was supported by the member states of theAVAREF, WHO and funded by the European and Developing Country Clinical Trial Partnership. ATM registry was later established as Pan African Clinical Trials Registry (PACTR). In September 2009, it was formally incorporated as WHO primary registry. PACTR delivered a platform for the prospective registration of clinical trials irrespective of the disease type. Currently, 22 African countries are represented by the registry. It offers registration via Internet, E-mail, post, and even by facsimile owing to Internet problems in most African countries. It offers retrospective registration of interventional trials and also encourages the registration of pilot studies.
South African Clinical Trials Registry
South African Clinical Trials Registry (SANCTR) launched in 2005 backed by the Department of Health and managed by the Medicines Control Council. All trials to be conducted in South Africa are required to be registered in SANCTR. However, SANCTR does not meet the requirements of the WHO; therefore, the trials are required to be registered both on SANCTR and WHO compliant registry to meet the publication requirements. It accepts prospective registration of trials.
Nigeria Clinical trials Registry
Nigeria Clinical trials Registry (NCTR) is a joint initiative of the NAFDAC, backed by the National Health Research Ethics Committee and the Federal Ministry of Health. Owing to the limited and unreliable access to the Internet experienced by individuals in several African countries, trials could be registered online, (via the Internet if access is sufficiently reliable) or by E-mail, postal mail, or facsimile. NCTR accepts registration for interventional randomized controlled trials and controlled clinical trials, pharmacokinetic/pharmacodynamic studies.
Tanzania Clinical Trial Registry
Clinical trials in Tanzania are governed by the Tanzania Food, Drugs and Cosmetics Act 2003. Registration of the trials requires the registration form to be filled along with a prescribed fee after ethical approval as per TFDA. A single Investigator can apply for an account, but she/he must have an organization as Tanzania Clinical Trial Registry recognize an organization and not a person. However, the account applied by the single investigator would be individual account. It mandates the prospective registration of trials to be conducted on humans.
AUSTRALIA: Australian New Zealand Clinical Trials Registry
Australian New Zealand Clinical Trials Registry (ANZCTR) was launched in the year 2005 jointly by Australia and New Zealand. The registry is funded and sponsored by Australian National Health and Medical Research Council's Enabling Grant scheme with co-funding by the New Zealand Health Research Council. The registry accepts trials from Australia, New Zealand and from elsewhere in the world and housed at the University of Sydney's NHMRC Clinical Trials Centre. It allows both prospective as well as retrospective registration of trials.
The scientific research in Antarctica is done in collaboration with Scientific Committee on Antarctic Research (SCAR), an interdisciplinary committee formed by the International Science Council in the year 1958. The nations who are the signatory to the Antarctic treaty have established their respective research stations there and are actively involved in research across various disciplines. All the research to be carried out there should be benefit to Antarctica as well as in Interest globally. The research usually carried out here is the ones which cannot be conducted anywhere except Antarctica. SCAR has formed numerous committees governing the research across various disciplines. The Joint SCAR-COMNAP Expert Group on Human Biology and Medicine is the forum for the management of safe and effective strategies concerning scientific research in the field of healthcare. As per the treaty provisions, all the results and scientific findings of studies carried out in Antarctica will remain freely available.
Animal study registry/preclinical study registry
Apart from the International register of preclinical trial protocols, very few registries offer registration for animal studies.
- Registry of industrial toxicology animal-data is an initiative by various pharmaceutical laboratories aimed at collecting the historical data pertaining to rodents involved in the carcinogenicity studies
- Animal health studies database developed and maintained by the American Veterinary Medical Association launched in the year 2106 serves as a registry as well as the database for providing information about various trials. It also serves as a virtual tissue bank where researchers can request tissues and samples of animals with certain conditions
- VetAllTrials was an initiative launched in 2015 that aimed at promoting evidence-based research and for the development of trial registries dedicated to the veterinary population
- International register of preclinical trial protocols is a prospective registry of trials meant for the registration of animal study protocols. It aims at not only at promoting transparency in research but also helps in reducing bias such as p-hacking and HARKing. It also reduces the duplication of studies. Although the chief emphasis is toward cardiac regenerative therapy, it accepts registration from other fields related to biomedical science. The registration is open for all countries and continents.
In vitro study registry
After extensive search, we could not find even a single in vitro study registry that keeps a track or record of all such trials being conducted all over the world or the one that allows registration for such trials. As almost all of in vitro trials are mainly concerned toward the preclinical development of drugs, researchers are reluctant to share the results prior due to patent issues. However, country-specific in vitro fertilization registries do exist and keep a record of in vitro fertilization procedures being conducted.
In silico/Simulation Research Registry
With the advent of technology, tech-savvy researchers are making use of simulation in research whereby clinical trials are done on the virtual patient population. Simulation saves human lives from undue harm by evaluation in a virtual scenario. The technique holds equally good for educational purposes and for the evaluation of new therapies. International Simulation Data Registry is the registry primarily meant for the registration of simulation research and currently employs 32 centers all over the world.
| » Discussion|| |
Trial registries help us to avoid duplication of research and also allows us to assess reporting bias. Registration of trials helps in preventing duplication of research, which helps in avoiding duplication of research and resultant manpower and financial and time loss. They serve as a potential tool for the identification and minimization of selective reporting; however, they are least utilized for this purpose. The maintenance cost of these registries is very high as evident from the budget allocated for the clinicaltrials.gov was around $3 million. We have a total of 17 primary registries and the total number of clinical study registries is 27. Looking into the number of countries across the globe, this figure is very minimal.
However, the current study registries lack comprehensive tracking system for reporting the results of all registered trials. To improve the scenario, a uniform strategy should be maintained and reporting of results should be mandatory. In case the trial is discontinued, the registry should be updated with the reason of discontinuation. Another negative point of the present system is that it is not mandatory to register the observational studies, so, in many cases obtaining a registered protocol for an observational study may be difficult. Another issue is that most of these clinical study registries don't register study protocols retrospectively. The indirect consequence of this fact is that, if the research work do not get published anywhere, there will not be any record of the existence of the research work and traceability won't be possible. The problem of retrospective registration may be solved by the inclusion of few parameters in the registry, for example, date of ethical permission, date of starting of the research work, date of application for registration in the trial registry, and date of grant of registration. This will allow the authors a detailed analysis of timelines of registration and will allow inferring regarding selective reporting bias. Another issue is the inconsistency of many registries regarding updating/nonupdate of the study details at real time or definitive time intervals. The quality clinical trial registry records have previously been identified as inconsistent.,
Coming to preclinical study registries, only few registries were found. However, the acceptability of preclinical study registries among researchers is a matter of debate. Many fears to register preclinical studies owing to the fear of loss of novelty (which may affect patent acquisition process). Another pole of this issue is issues related to confidentiality. Researchers or companies involved may consider the information related to the study to be proprietary (especially in case of in silico studies) and publication of the structural details of the ligands or targets may lead to competitive disadvantage and disadvantage in case of intellectual property rights.
| » Conclusion|| |
The study registry platforms are landmark initiatives which allow us to decide about the transparency and accountability of research work. However, nonexistence of research study registry in some countries may place the research participants in a trap as it will not allow regulatory access and may lead to nontransparency and exploitation. To update with the principles of accountability and transparency, the research registries should also update themselves. However, many a times, a diligent nonupdating of the status research work is seen in registries. In this regard, suitable bounding legislation can be of help, for the establishment of mandatory updating of the status of research into the registry by either the investigator or the sponsor. Although retrospective registration of studies nullifies many benefits of registration of studies, a detailed display of different timelines of the study may help in understanding the risk of selective reporting bias by analyzing the timelines. In this regard, a uniform global reporting/registration guideline may be of help. The establishment of a quality control/assurance department of the registry may prove helpful in this regard.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| » References|| |
Simes RJ. Publication bias: The case for an international registry of clinical trials. J Clin Oncol 1986;4:1529-41.
Chalmers I. Underreporting research is scientific misconduct. JAMA 1990;263:1405-8.
Dickersin K, Rennie D. Registering clinical trials. JAMA 2003;290:516-23.
Ghersi D, Pang T. En route to international clinical trial transparency. Lancet 2008;372:1531-2.
Chinese Clinical Trial Register (ChiCTR)-The world Health Organization International Clinical Trials Registered Organization Registered Platform. Available from: http://www.chictr.org.cn/abouten.aspx
. [Last accessed on 2019 Aug 19].
Acupuncture Clinical Trial Registration Center site-The World Health Organization International Clinical Trials Registered Organization Registered Platform. Available from: http://www.acmctr.org/enIndex.aspx
. [Last accessed on 2019 Dec 26].
Chan AW, Altman DG. Epidemiology and reporting of randomised trials published in PubMed journals. Lancet 2005;365:1159-62.
DRKS-Deutsches Register Klinischer Studien (German Clinical Trials Register). Available from: https://www.drks.de/drks_web/
. [Last accessed on 2019 Aug 19].
Nolte T, Rittinghausen S, Kellner R, Karbe E, Kittel B, Rinke M, et al
. RITA—Registry of Industrial Toxicology Animal data: The application of historical control data for Leydig cell tumors in rats. Exp Toxicol Pathol 2011;63:645-56.
Informatics L. Veterinary All Trials Initiative. Veterinary All Trials Initiative; Available from: http://vetalltrials.org/
. [Last accessed on 2019 Sep 22].
National Registry of Assisted Reproductive Technology (ART) Clinics and Banks in India | Indian Council of Medical Research | Government of India. Available from: https://www.icmr.nic.in/national-registry-of-art
. [Last accessed on 2020 Jan 24].
Zarin DA, Ide NC, Tse T, Harlan WR, West JC, Lindberg DA. Issues in the registration of clinical trials. JAMA 2007;297:2112-20.
Ross JS, Tse T, Zarin DA, Xu H, Zhou L, Krumholz HM. Publication of NIH funded trials registered in ClinicalTrials.gov: Cross sectional analysis. BMJ 2012;344:d7292.
Viergever RF, Ghersi D. The quality of registration of clinical trials. PLoS One 2011;6:e14701.
Viergever RF, Karam G, Reis A, Ghersi D. The quality of registration of clinical trials: Still a problem. PLoS One 2014;9:e84727.
[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2]