CLINICAL TRIAL REGISTRATION: CAN WE ESTABLISH NATIONAL CLINICAL TRIAL REGISTRY OF PAKISTAN?

Abstract

International Committee of Medical Journal Editors(ICMJE), previously known as Vancouver Group, is aselected group of editors from leading international medicaljournals like New England Journal of Medicine, TheLancet, British Medical Journal, Journal of AmericanMedical Association etc. ICMJE is working hard for theimprovement of published medical research and hasdeveloped Uniform Requirements for Manuscripts (URM)submitted to biomedical journals which are regularlyupdated and are adopted by majority of medical journalsacross the globe1. Besides developing guidelinesfor authors regarding preparation and submission ofmanuscripts, ICMJE is deeply concerned with the issuesrelated to publication ethics like authorship, contributorship,editorship, peer review, conflicts of interest, privacy,confidentiality and protection of human subjects andanimals in research.A major issue in publishing medical research is thepublication bias2. The researchers and editors are moreinterested in publishing the studies with positive results,published more frequently and quickly than trials withnegative outcomes3. Selective publication is unscientificand unethical as the hidden results may alter the clinicalevidence and the clinical practice. To confront the publicationbias, Simes RJ4 proposed to establish an internationalregistry of clinical trials where the objectives andendpoints of every clinical trial may be recorded in theregister. In September 2004, ICMJE proposed a comprehensivetrials registration policy as a possible solutionto the publication bias5. This policy was implementedin July 2005 on 12 member journals of ICMJE and registrationin a public trial registry was made a prequisite forpublication of all clinical trials.For registration purposes, ICMJE is endorsing theWorld Health Organization (WHO) definition of a clinicaltrial as “any research study that prospectively assignshuman participants or groups of humans to one or morehealth-related interventions to evaluate the effects onhealth outcomes”6. Health-related interventions includedrugs, surgical and radiological procedures, devices, behavioraltreatments, dietary interventions etc. All clinicaltrials meeting the above mentioned definition (includingphase I to phase IV trials) are required to be registeredat or before the enrollment of patients in the trial. Howeverpurely observational studies are exempted from registration7.World Medical Association Declaration ofHelsinki also stressed upon registering every clinical trialin a publically accessible database before recruitmentof the first subject8. The database where standardizedinformation about administration and scientific contentsof clinical trials are stored is called as Clinical trial register.The clinical trial register is maintained by clinical trialsregistry which is responsible for ensuring the validityand accuracy of the trial information and disseminationof these information to health care decision making authorities6.To ensure that all clinical trials are not only registeredbut are publically available and clearly identifiable,WHO has established International Clinical Trials RegistryPlatform (ICTRP)9. To facilitate the unambiguous identificationof clinical trials, every trial is allotted a uniqueUniversal Trial Number (UTN) which is not a registrationnumber but it identifies the individual trial and is used inthe trial protocol and all the communications about thetrial. WHO Registry Network for prospective trial registriesfacilitates the exchange of information and workingrelationship among all the registries. The WHO RegistryNetwork has laid down specific criteria based on content,quality and validity, accessibility, unique identification,technical capacity and administration for the trialsregistries. Depending upon the eligibility criteria, trialsare categorized as Primary Registries, Partner Registriesand Registries working with the ICTRP towards becomingPrimary Registries. Primary Registries meet all thecriteria of ICTRP and are run by nonprofit organizations10.ICMJE does not favour any particular registry and all PrimaryRegistries designated by WHO ICTRP are acceptableto ICMJE7. Clinicaltrials.gov developed in the year2000 is the first and the largest clinical trials registry inthe world11,12.Unfortunately there is no trial registration authorityin Pakistan and many local researchers get their trialsregistered with international registries before publishingtheir research in international journals of repute. Due tonon-availability of national trial registry, Pakistani journalsare experiencing problems in accepting articles withoutUTNs. The regulatory authorities of health care, medicaleducation and medical research in Pakistan like PakistanMedical & Dental Council (PMDC), Higher EducationCommission (HEC), College of Physicians and surgeonsPakistan (CPSP) and Pakistan Medical ResearchCouncil (PMRC) need to take an initiative to establish astandard trial registry which should meet the WHO criteriaof primary registries. When Iran13, India14 and SriLanka15 can establish their own trial registries and getthem recognized from WHO as primary registries, whynot Pakistan can do it?KMUJ 2012; Vol. 4, No. 2: 36-37 37CKCKCKCKREFERENCES1. International Committee of Medical Journal Editors(ICMJE): Journals Following Uniform Requirementsfor Manuscripts. http://www.icmje.org/journals.htmlaccessed on March 23, 2012.2. Simes RJ. Publication bias: the case for an internationalregistry of clinical trials. J Clin Oncol 1986; 4:1529-41.3. Hopewell S, Loudon K, Clarke MJ, Oxman AD,Dickersin K. Publication bias in clinical trials due tostatistical significance or direction of trial results.Cochrane Database Syst Rev 2009 Jan 21; (1):MR000006.4. Simes RJ. Confronting publication bias: A cohort designfor meta-analysis. Stat Med 1987; 6(1): 11-29.5. Clinical Trial Registration: A Statement from the InternationalCommittee of Medical Journal Editors. Editorial.2004. Available on: http://www.icmje.org/clin_trial.pdf accessed on March 23, 2012.6. World Health Organization: Frequently Asked Questions.http://www.who.int/ictrp/faq/en/index.html#faq3accessed on March 23, 2012.7. Clinical Trial Registration: Looking Back and MovingAhead. Editorial June 2007. Available on: http://www.icmje.org/update_june07.html accessed onMarch 23, 2012.8. World Medical Association Declaration of Helsinki -Ethical Principles for Medical Research Involving HumanSubjects. October 2008. Available on: http://www.wma.net/en/30publications/10policies/b3/17c.pdf accessed on March 23, 2012.9. World Health Organization. International Clinical TrialsRegistry Platform. Available at http://www.who.int/ictrp/about/details/en/index.html10. World Health Organization: About Registries. http://www.who.int/ictrp/network/primary/en/index.html accessedon March 23, 2012.11. McCray AT, Ide NC. Design and implementation of anational clinical trials registry. J Am Med Inform Assoc2000; 7(3): 313-23.12. National Institutes of Health LaunchesClinicalTrials.gov Results Database. http://www.nlm.nih.gov/news/expanded_clinicaltrials.htmlaccessed on March 23, 2012.13. Iranian Registry of Clinical Trials (IRCT) Available at.http://www.irct.ir/14. Clinical Trials Registry - India (CTRI) Available at http://www.ctri.in/15. Sri Lanka Clinical Trials Registry (SLCTR). Availableat http://www.slctr.lk/

Dr. Akhtar SherinManaging EditorKhyber Medical University Journal (KMUJ)Khyber Medical University Institute of Medical SciencesDHQ Teaching Hospital, KDA Kohat, PakistanEmail: akhtarsherin@yahoo.com; kmuj@kmu.edu.pk