Supporting Ethical Research

Ethical research is research that:

  • Upholds the core ethical principles of respect for persons, beneficence and justice
  • Protects the rights, safety and the well-being of human subjects
  • Is compliant with all applicable statutory regulations and guidelines

The Malaysian Good Clinical Practice and Code of Responsible Conduct in Research guides researchers in upholding ethical standards in their work.
 
Individuals who undertake research at RSDH facilities must adhere to these guidelines and all other applicable statutory regulations.

 Criteria for approval of a given research study 

 In order to be approved for a clinical study at one of SJMC’s exceptional research hospitals, the following criteria must be met in full: 

  • Scientific design and method of the study – research is ethically acceptable only if it relies on valid scientific methods
  • Risks and potential benefits – risks are minimised, and are reasonable in relation to anticipated benefits
  • Appropriate selection of study population and recruitment of research participants
  • Inducements, financial benefits, and financial costs – the amount and method of payment to subjects are such as to assure them, neither present problems of coercion or undue influence on the trial subjects
  • Protection of research participants’ privacy and confidentiality
  • Includes an informed consent process
  • Respects community considerations

Research Output:

These are some of the latest research publications from our centre. For a full list of publications, you may refer to this link.

Study Title Journal Link Month of Publication

Treatment Patterns In Patients With Mantle Cell Lymphoma: Updated Report Of The Asia‐pacific Multinational Retrospective Registry Study

Hematological Oncology DOI:10.1002/hon.3165_604
June 2023

Asia-Pacific Leukemia Consortium: An innovative and collaborative initiative to improve care of leukemia and related diseases in the Asia-Pacific region

Asia-Pacific Journal of Clinical Oncology
DOI:10.1111/ajco.13970
June 2023

TP53 somatic mutations in Asian breast cancer are associated with subtype-specific effects

Breast Cancer Research
DOI:10.1186/s13058-023-01635-2
April 2023

Expert consensus on the management of chronic lymphocytic leukaemia in Asia

Clinical and Experimental Medicine
DOI:10.1007/s10238-023-01007-2
February 2023

Mutational Profiling of Lung Cancer Using Next Generation Sequencing: A Malaysian Real-World Clinical Diagnostic Experience

Journal of Molecular Pathology
DOI:10.3390/jmp4010004
January 2023

Real World Treatment Outcomes for Patients with Multiple Myeloma Undergoing Autologous Stem Cell Transplant in Different Income Countries within Asia Pacific Region

Blood – Published by American Society of Hematology
DOI:10.1182/blood-2022-164888
November 2022


Ongoing Clinical Trials:

You may reach out to our Clinical Trial Unit if you are interested to find out more about the criteria or participate in an active clinical trial.

Study Title Target Group Current Status

A Phase 3 Randomized Study Comparing Teclistamab Monotherapy versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma who have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide (Majestec-9).

Relapsed or Refractory Multiple Myeloma
Actively Recruiting

A phase 3 randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to eltrombopag in patients with primary immune thrombocytopenia (ITP) who had an insufficient response or relapsed after first line steroid treatment (VAYHIT2).

Primary Immune Thrombocytopenia (ITP) with insufficient response / relapse after first line treatment
Recruitment closed. 
Patients under treatment phase.

A phase III, multi-center, open-label, randomized study of oral asciminib versus Investigator selected TKI in patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase.

Chronic Myelogenous Leukemia
Treatment Phase

A phase 3, multicenter, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of tafasitamab plus lenalidomide in addition to R-CHOP versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed diffuse large B-cell lymphoma (DLBCL) [frontMIND].

Diffuse Large B-Cell Lymphoma (DLBCL)
Follow up Phase

A Phase 3, Open label, Randomized Study Comparing the Efficacy and Safety of Odronextamab, an anti CD20 × anti-CD3 bispecific antibody, in Combination with CHOP (O-CHOP) versus Rituximab in combination with CHOP (R-CHOP) in Previously Untreated Participants with Diffuse Large B-cell Lymphoma (DLBCL) (OLYMPIA-3).

Diffuse Large B-Cell Lymphoma
Actively Recruiting

Site 458-405 A Phase 3, Randomized, Open Label Study Evaluating the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, versus Standard of Care Therapy in Participants with Relapsed/Refractory Aggressive B-cell non-Hodgkin Lymphoma (OLYMPIA-4).

Relapsed/Refractory Aggressive B-cell non-Hodgkin Lymphoma
Actively Recruiting

Site 458-505 A Phase 3, Open Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Combination with Lenalidomide Versus Rituximab in Combination with Lenalidomide in Relapsed/Refractory Participants with Follicular Lymphoma and Marginal Zone Lymphoma (OLYMPIA-5).

Relapsed/Refractory Participants with Follicular Lymphoma and Marginal Zone Lymphoma
Actively Recruiting