HKUCTR

What is HKU Clinical Trials Registry?

HKU Clinical Trials Registry (HKUCTR) is a public online registry established at the Clinical Trials Centre, The University of Hong Kong (HKU-CTC) in June 2005, with management support from the Li Ka Shing Faculty of Medicine, The University of Hong Kong. HKUCTR’s primary objective is to serve as a clinical trials information platform, which is freely accessible by the public from local and overseas. HKUCTR constitutes clinical trials (either conducted at The University of Hong Kong/Hospital Authority Hong Kong West Cluster (HKU/HA HKWC) or elsewhere outside HKU/HA HKWC) of various types of intervention, including pharmaceutical products, traditional/proprietary Chinese medicines, herbal medicines, medical devices, surgical procedures, dentistry, complementary medicines, preventive measures, nursing procedures/services, other treatment and rehabilitation strategies as well as from full-spectrum of therapeutic areas, e.g. oncology, cardiovasculogy, endocrinology etc.

Why is Clinical Trials Registration Necessary?

Background:

Clinical trials registration is an international requirement at current, which had first drawn the attention of the researchers since the implementation of the policy by the International Committee of Medical Journal Editors (ICMJE) in July 2005. The U.S. Food and Drug Administration later revised its regulations and included those requirements in the Food and Drug Administration Amendment Act (FDAAA) in September 2007, where the requirement of clinical trials registration further arouse the global awareness when the World Medical Association adopted the principle in the version of Declaration of Helsinki in 2008.

Key objectives of public clinical trials registration:

1. Avoiding publication bias through selective reporting of clinical trials with positive results.
2. Preventing unnecessary duplication of research effort.
3. Increasing the awareness of clinical trials activities by the general public.
4. Facilitating recruitment of clinical trials subjects.

Prerequisite for scientific publication:

Prospective registration^[1] of clinical trials with any of the Primary Registries recognized by the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) or with the U.S.-based registry (www.ClinicalTrials.gov) before trial initiation^[2] is a prerequisite for a manuscript of clinical trials^[3] to be considered for publication by the ICMJE member journals or other peer-reviewed scientific journals which adopted the same policy.

Why Register with HKUCTR?

Although HKUCTR is not a Primary Registry under WHO ICTRP, nevertheless investigators and/or sponsors are still recommended to register their clinical trials for the following purposes:

1. Increasing the awareness of clinical trials activities in Hong Kong by the Hong Kong local society.
2. Serving as an extra channel for recruitment of clinical trials subjects, in particular for local Chinese population.
3. Contributing to the HKU clinical trials database required for securing and maintaining relevant insurance coverage.

What Information Can I Find on HKUCTR?

Each study record registered with HKUCTR outlines a summary of the study protocol which includes the following key areas:

• Study registration and background information
• Study type, design and methodology
• Study contact information
• Study funding support
• Study results (if available)

HKUCTR complies with the minimum 20-item trial registration dataset requirements set out by the ICMJE and WHO. Once the trial is successfully published on HKUCTR, a unique “Study Identifier” will be allocated for reference.