Rudiments on ICTRP (International Clinical Trials Registry Platform)- Pius Augustine Ph.D,

Clinical trial and trial registration is to make available various research results on a particular medical issue to all those who are in need and in a way to assist the health care officials in decision making. This will make the research more scientific, ethical, transparent and dependable. It is the moral responsibility of the scientists to ensure that the research they carried out is ethically valid and reported to the authorized agency.

The clinical trial is a research study in which human participants or group of humans are involved in, to understand or establish a response to health-related interventions. Here intervention is a broad term: may include but not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioral treatments, process-of-care changes, preventive care, etc.

Established or Internationally acceptable results of a clinical trial will be made available to the health workers or hospital staff to practice through a process called trial registration. This trial registration ensures that the pieces of evidence of the clinical trial are accessible and there is no bias or selective reporting in the publication process. ie. trial registration confirms the Declaration of Helsinki which states that "Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject". Wastage of time and money on the duplication of the established or ongoing research will be checked/minimized and also the research collaborations can be facilitated through the process of trial registration. Also, the registration process attests to the quality of the clinical trials and locates the potential problems, if any in the research progress. 

Registration is not carried out with WHO or WHO ICTRP, but with anyone of the Primary Registries in the WHO registry network or International Committee of Medical Journal Editors (ICMJE)  approved registry. Clinical trial and registration formalities would vary from one country to the other and the entire process is expected to strictly abide by the regulations stipulated by the respective countries. The record of the registered clinical trial would be stored and managed using a database.  However, more than a database, broader terminology is ‘clinical trial registry’ which is an entity that houses the complete and accurate information of the registered clinical trials and is used for health care decision making.  

When the registration process is initiated, a trial number (early in the history of the trial) called UTN (Universal Trial Number) will be given to facilitate unambiguously identification of clinical trials. However, if the trial is not fully developed or does not recruit participants, UTN may not appear attached to a registered trial.

ICTRP is a global initiative which makes publicaly available all the clinical trials involving human beings. ICTRP was established in 2006 on demand by the countries to the World Health Assembly for: "a voluntary platform to link clinical trials registers in order to ensure a single point of access and the unambiguous identification of trials with a view to enhance the access to information by patients, families, patient groups and others"  Reference: WHO official site

 Assistant Professor,  Sacred Heart College, Thevara, Kochi.