General Queries

What is a Clinical Trial?

clinical trial is a type of research that studies a test or treatment given to people.

  • Clinical trials study how safe and helpful tests and treatments are
  • When found to be safe and helpful
What is a Clinical Trials Registry?

A registry is defined as an organization or website that either:

  • lists clinical trials being conducted (or that have recently been conducted)
  • provides a mechanism for patients or others to register their interest in participating in a clinical trial
  • provides a link between potential participants and clinical trials.
What is the history of clinical trial registry?

Following the Ministerial Summit on Health Research that took place in Mexico City, Mexico, in November 2004, participants called for the WHO to facilitate the establishment of: "a network of international clinical trial registers to ensure a single point of access and the unambiguous identification of trials".

This was further expanded on during the 58th World Health Assembly in Resolution WHA58.22 that called on the global scientific community, international partners, the private sector, civil society, and other relevant stakeholders to: "establish 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 enhancing access to information by patients, families, patient groups and others".

 

Who can access the NPCTR?

NPCTR is a web-based registry with worldwide free and open access to researchers, clinicians and the general public.

Who can register a clinical trial with the NPCTR?

Any investigator from Nepal or overseas can register a clinical trial with the NPCTR. The responsibility for registering a trial lies with the principal investigator or principal sponsor of the trial. For multi-center trials, the principal investigator or sponsor should take responsibility for registration.

Requirement of clinical trial registry in Nepal

WHO/ICTRP mandate to establish a trial registry at the convenient places for a researcher.

[Note: Drug Act 2035 mentioned any person who intends to carry out a clinical trial of any new drug shall obtain a license from the department, as prescribed, for such trial. For conducting the clinical trial in Nepal, medicine registration guidance (Issued under Drug Registration Regulation 2038) section 2.18 mentions the approval of the Nepal Health Research Council (NHRC) and other government-approved agencies are required.]

What is required to register in clinical trial registry?
  • Trail Protocol (Proposal)
  • Approved ethical clearance letter
  • Agreement letter from a study site
  • Researcher profile
How the investigator will register their trial at NPCTR?
  • Go through the online portal (https://​​npctr.nhrc.gov.np).
  • Registration, login
  • Fulfill all data set.