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Adventist Clinical Research Centre

ACRC started officially in 2012 and is actively participating in clinical trials. ACRC is a one-stop centre that supports high quality research which contributes to the improvement of patient care and health outcomes, while adopting the highest scientific and ethical standards expected of international trials, guided by the Good Clinical Practice (GCP) guidelines.

ACRC has been established to:

  • Offer state-of-the-art facilities to pharmaceutical companies to conduct their research studies.
  • Assist potential investigators to conduct clinical trials.
  • Assist investigator to screen and match patients with ongoing or upcoming clinical trials that are most suitable to their medical condition(s) and health status.
  • Connect professionals who are conducting clinical research studies with eligible candidates.

Clinical Trial Services:

ACRC serves as a coordinating centre for clinical trial. We have the expertise and capability to conduct clinical trials at our fully-equipped site. We offer a full range of services for studies in phase III. We offer experience, commitment, and creative resources to diverse therapeutic areas, thus acquiring a comprehensive scope of clinical services.

Clinical trials and their ensuing positive outcomes can impact the health of people around the world by bringing these advancements to the marketplace and making them readily available to those in need. There are many advantages to conducting clinical trials, including:

  • Offering patients medical treatment that might not otherwise be available.
  • Being on the cutting edge of your therapeutic area of expertise.
  • Collaborating with the brightest minds of our time.
  • Gaining familiarity with medications and therapies before they reach the market.
  • Adding supplementary revenue to your medical practice for the time spent conducting clinical trials.

Ongoing Clinical Trials:

1.  Nasopharyngeal carcinoma (Phase III)
(Status: Recruiting)

Joint-Penang Independent Ethics Committee (JPEC) approval number for the study: 01-0005
Joint-Penang Independent Ethics Committee (JPEC) approval date for the study: 03 Feb 2014

Patient with metastatic or locally recurrent EBV-positive.

The aim of this study is to assess the efficacy of Cytotoxic T Lymphocytes following first line chemotherapy in prolonging Overall Survival (OS) of patients with advanced Nasopharyngeal carcinoma.

Eligible patients who are enrolled in the trial will receive treatment at minimum or at no cost at the medical centre participating in the trial.

Taking part in the study will provide new information that will add to the current knowledge about nasopharyngeal cancer treatment, which may help other patients in the future.

If you are interested in participating in our Clinical Studies, Kindly send us an email or call 04 2289566 (ext:241) or walk into Adventist Oncology centre or call 04 222 7338/ 04 222 7337.

Joint-Penang Independent Ethics Committee (JPEC) approval number for the advertisement: 14-0103
Joint-Penang Independent Ethics Committee (JPEC) approval date for the advertisement: 02 Oct 2014


Research services:

ACRC welcome researcher who has interest to conduct research in PAH. We process all research application to PAH according to the Policy and Procedures of Research Application. We process all types of research projects ranging from research application by staff of PAH, research application by Sponsors/Companies, and research application by academic students. Complete research application will go to research committee for review and approval. Upon approval, such application will go to Medical Dental Executives committee which meet every Tuesday in first week of the month for review and approval. PAH requires all researchers to be GCP certified.


Useful Info / Frequently Asked Questions

What is clinical research / clinical trial?

Clinical research is an integral part of the drug development process. It involves systematic measures used to assess the safety & efficacy of new medicines in human subjects. Often the clinical study or clinical trial compares the new treatment (commonly referred to as "investigational drug") under evaluation with a placebo (an inactive substance designed to resemble the drug being tested) or the current standard treatment; Clinical Trials is any systemic evaluation of new medicines in human subjects whether in patients or healthy volunteers to discover or verify the potential benefits and and/or identify any adverse reactions or side effects to the new drug.

Who Conducts Clinical Studies?

Every clinical study has a research team led by a Principal Investigator and/or Co-Investigators who is often a medical doctor, Study Coordinator, Research Nurse and other health care professionals.

How are clinical trials executed?

Clinical trials are executed in four distinct phases (steps) designed to answer specific research questions. Each phase of the clinical trial has a specific goal and the information gathered is used to build knowledge on the new drug and support the subsequent phases of the drug development process.

Phase I Study The first of four phases of clinical trials. Phase I studies are designed to establish the effects of a new drug in humans. These studies are usually conducted on small groups of healthy volunteers (20-80) to specifically determine a drug's toxicity, absorption, distribution and metabolism.
Phase II Study After the successful completion of phase I trials, a drug is then tested for safety and efficacy in a slightly larger population of individuals (100-300) who are afflicted with the disease or condition for which the drug was developed.
Phase III Study The third and last round of testing of a new drug is conducted on large populations of afflicted patients (1,000-3,000). Phase III studies usually test the new drug in comparison with a placebo or the standard therapy currently being used for the disease in question. The compiled results from the Phase I to Phase III studies are used to support the application to market the new drug submitted to the regulatory agencies (for example the U.S. FDA). The results of the Phase III trials usually provide the information that is included in the package insert and labelling once the new drug is marketed.
Phase IV Study After a drug has been approved by the FDA, phase IV studies are conducted to compare the drug to a competitor, explore additional patient populations, or to further study any adverse reactions or side effects. All phases of clinical trials are executed according to a pre-established protocol or study plan. All protocols are conducted according to Good Clinical Practices (GCPs) and has approved from Institutional Review Board/ Independent Ethics Committee (IRB/IEC).

Who should consider participating in a clinical trial and why?

People who have exhausted standard (approved) treatment options - which either did not work for them, or they were unable to tolerate certain side effects can consider participating in a clinical trial as it may provide another option when standard therapy has failed.

People can also participate in trials simply because they want to contribute to the advancement of medical knowledge through the findings of the study.

The benefits of participating in well-designed and well-executed clinical trials are having the chance to be actively involved in their health care, gain access to potentially new research treatments, have access to expert medical care for the condition being studied, and help others by contributing to medical research. Participation in a clinical trial is always voluntary.

What are the benefits of participating in clinical trial?

Clinical trials and their ensuing positive outcomes can impact the health of people around the world by bringing these advancements to the marketplace and making them readily available to those in need. There are many advantages to conducting clinical trials, including:

  • Offering patients medical treatment that might not otherwise be available.
  • Being on the cutting edge of your therapeutic area of expertise.
  • Collaborating with the brightest minds of our time.
  • Gaining familiarity with medications and therapies before they reach the market.
  • Adding supplementary revenue to your medical practice for the time spent conducting clinical trials.

Why must I sign inform consent before participating in a clinical trial?

Prior to entering a clinical trial, subjects must sign an informed consent.

Informed Consent: The process of verifying and documenting that a study participant willingly accepts to participate in a clinical trial. The informed consent is signed only after the subject has received complete, objective information about the clinical trial, including its objectives, potential benefits, risks and inconveniences, alternative therapies that may be available (if applicable), and the subject's rights and responsibilities in accordance with the current revision of the Declaration of Helsinki. The subject's rights to confidentiality while participating in a clinical trial is also covered in the informed consent. The informed consent also has the provision to inform the subject of any new information which is made available during the course of the clinical trial which may affect his/her continued participation in the study. The informed consent also specifies that participation in the clinical study is voluntary and that the subject can choose not to participate or can leave the clinical study at any time even after he/she has consented to participate. The informed consent is not a contract and the participant is not bound in any way. In sum, the rights of the person are safeguarded and protected at all times.

What is Good Clinical Practices (GCPs)?

GCP is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.

Why do I need to have GCP / Who should have the certification?

If your research involves research in human beings, this is a certification you must have. Researchers planning or currently engaged in clinical trials, clinical research associates, research managers or trials monitors working with pharmaceutical companies or contract research organisations will draw direct and immediate benefits. It will also bring you up to speed in conducting publishable world-class trials. Attending a GCP workshop is also a great opportunity to network with researchers and sponsors as well as research service providers. There is often rich cross pollination of ideas.

How do I get GCP certified?

You can get certified through yearly workshops organised by the government or private healthcare sector which is usually be a two and a half day event. You can also get certified though a free online course.



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Operation Hours

Mon - Fri : 8:00am - 5:00pm
Sat - Sun : Closed
Public Holiday : Closed


Contact

We gladly welcome the possibilities of any research or clinical trial collaboration.
For further information, kindly contact:

Adventist Clinical Research Centre
Tel: (+604) 228 9566 / 226 1566  Ext. 241
Email: