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For Health Professionals

Clinical Research


Research Volunteers


Why Participate in Clinical Research?

You will contribute to the wellbeing of society, and the advancement of medical research, bringing new hope for patients afflicted with different conditions and diseases. Future generations, your children or grandchildren included, will benefit from the research. It may also benefit you, as you can learn more about your illness or condition and the treatment options, and have access to new medications and procedures. Whatever your reasons, participation is voluntary. We invite you to join us in gaining better understanding of diseases and improving healthcare in Singapore.

Metformin Research Study

Metformin is one of the best treatments for Type 2 Diabetes, but it does not agree with everyone. We are looking to see if there is anything special in the genes of patients who respond to Metformin treatment differently.

Information

Eligibility:

  • Age 21 to 80 years old
  • Have Type 2 Diabetes
  • No History of Cancer and/or gastrointestinal diseases

When taking Metformin:

  1. Have stomach-related problems
  2. Had to completely stop taking it
  3. Had to take Meformin XR instead

Contact Number:

964 306 98

Email:

yeo.michelle.hh@ktph.com.sg

Time:

(Mon-Fri, 9am - 12pm or 1pm - 5pm)

Collection, use and disclosure of your personal data shall be in accordance with our privacy policy

Diabetes Study

We are looking for volunteers for a 3-year study to find out which of two treatment processes is better at treating Type 2 Diabetes in overweight patients: Surgery or the best medical treatment.

Information

Eligibility:

  • Type 2 diabetes for less than 10 years
  • Age 21 – 65 years old
  • BMI between 27 and 32
  • Willing to have either surgery or the best medical treatment
  • Not pregnant or planning to get pregnant before the end of the study

Contact Number:

973 874 08

Email:

cheng.anton.ks@ktph.com.sg

Collection, use and disclosure of your personal data shall be in accordance with our privacy policy

SMART2D Study

We are calling for research volunteers who have taken part in the diabetes study in 2011-2014 organised by Khoo Teck Puat Hospital's Clinical Research Unit to participate in a follow-up study. This research investigates the risk factors affecting blood vessel function, eye, kidney and foot complications in people with Type 2 diabetes.

Information

Eligibility:

  • Participants of our previous study
  • Have Type 2 Diabetes
  • Not pregnant

Contact Number:

812 894 42

Email:

ktph.smart2d@ktph.com.sg

Time:

(Mon-Fri, 9am - 12pm or 2pm - 4.30pm)

Collection, use and disclosure of your personal data shall be in accordance with our privacy policy

Diabetes Kidney Disease Study

DKD is a common diabetic complication which affects the kidneys. Over time, kidney function is lost, leading to the need for dialysis. DKD patients commonly experience a loss in their quality of life.

Research has shown that DKD tends to occur more frequently in families with a history of DKD. This pattern may be caused by a shared lifestyle among family members. This includes shared diet and behavior.

Information

Eligibility:

  • Families with a strong history of Type 2 Diabetes
  • 5 direct family members must take part
  • All participants must be aged 21 to 99 years old

Contact Number:

911 358 91

Email:

ktph.fam.study@ktph.com.sg

Time:

(Mon-Fri, 9am - 12pm or 2pm - 4.30pm)

Collection, use and disclosure of your personal data shall be in accordance with our privacy policy

Monogenic Diabetes Study

MODY (Maturity-Onset Diabetes of the Young) is a form of monogenic diabetes that is caused by a single gene abnormality (mutation). Our research study aims to identify potential MODY patients for genetic testing to determine the mutation which will help doctors better understand the disease and treat the patients. The MODY Registry provides a platform to gather information for further studies of monogenic diabetes that will serve the interests of patients and healthcare providers.

Information

Principal:

Associate Professor Lim Su Chi

Investigator:

Senior Consultant, Diabetes Centre Clinical Director, Clinical Research Unit, Khoo Teck Puat Hospital

Recruitment Period:

Until March 2020

Eligibility:

  • Age 6-99 years old
  • Diabetes diagnosed at 35 years old or less
  • Additional criteria applies (eligibility to be confirmed by study team)

Cost:

For eligible and consented participants:

  • No charge for tests performed as part of the study
  • One-time transport reimbursement provided

Contact Number:

975 523 52 (Jessie Fong)

Email:

ktph.mody.registry@ktph.com.sg

Time:

(Mon-Fri, 9am - 12pm or 2pm - 4.30pm)

Collection, use and disclosure of your personal data shall be in accordance with our privacy policy

Neurological Foot Testing

We are calling for research volunteers to participate in several non-invasive tests and questionnaires for foot screening to help us establish normal and abnormal readings of these foot tests.

Information

Recruitment Period:

Now till 31 March 2018

Eligibility:

  • No diabetes and neurological symptoms
  • Have pre-diabetes
  • Have Type 2 diabetes

Cost:

No charge for test; travel expenses to be reimbursed

Contact Number:

660 223 46

Email:

ktph.smart2d@ktph.com.sg

Time:

(Mon-Fri, 9am - 12pm or 2.00pm - 5.00pm)

Collection, use and disclosure of your personal data shall be in accordance with our privacy policy

Participant Information & Rights

Association for the Accreditation of Human Research Protection Programs

For our efforts in achieving a high standard for ethics, quality and protection of people in research, KTPH is one of the few institutions in Singapore to be awarded the Full Accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

AAHRPP is a non-profit organisation that accredits institutions conducting research for achieving high quality of research work and protection of participants.

To attain the accreditation, KTPH has to submit a report on our Human Research Protection Programmes and undergo stringent on-site review by a team of experts from AAHRPP at scheduled intervals. For more information, please visit the AAHRPP website.

ICH E6(R2) Good Clinical Practice (ICH E6 GCP) Guidelines

At KTPH, the wellbeing and safety of research participants take precedence above all our activities. To ensure the protection of our participants in clinical trials and reliability of clinical trial results, we adhere strictly to the guidelines provided by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). For more information and a copy of the guidelines, please visit the ICH website.

All clinical research or clinical trials require ethics approval prior to commencement.

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Frequently Asked Questions

What is clinical research?

Clinical research refers to the process whereby a drug is developed in the lab and introduced to the consumer market. A promising drug candidate identified in the lab is subjected to pre-clinical and animal studies for safety and toxicity tests before permission from regulatory authorities is obtained to initiate trials on human subjects.

What is a clinical trial?

There are four phases of clinical trials, each with a specific aim.

  • Phase I – First stage of testing in human subjects to test for the safety, tolerability and general mechanism of action of the drug in humans. The drug is administered to a small number of healthy volunteers to determine the dose tolerability in human subjects. Currently, KTPH does not conduct Phase I studies.
  • Phase II – To determine the efficacy of the drug or device with volunteers with a specific disease.
  • Phase III - To determine the safety and efficacy of the investigational drug or device in different clinical settings. The outcome of the trial would be used for the basis of labeling in the market.
  • Phase IV – To determine long-term safety and new indications to the label after it is cleared by regulatory authorities for marketing.

Who can participate?

All clinical trials have guidelines on participants of clinical trials called inclusion/exclusion criteria. These criteria are based on factors like age, gender,  type and stage of a disease, previous treatment history and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, they are used to identify appropriate participants to ensure their safety and wellbeing. The criteria also help to ensure that researchers will be able to answer the questions they plan to study.

What are the benefits and risks of participating in a clinical trial?

Benefits:
Well-designed and well-executed clinical trials are the best approach for eligible participants to:

  • Play an active role in their healthcare by speeding up potentially more effective new treatments
  • Contribute in research efforts that can lead to potentially better health treatments for thems and their future generation
  • Gain access to new and potentially more effective treatments before they are widely available
  • Receive expert medical care at leading health facilities during the trial

Risks:
Clinical research, like medical treatments, always involve risks.

  • There may be unpleasant, serious or even life-threatening side effects resulting from the treatment.
  • The new treatment may not be as effective as currently available treatments.

How is the safety of participants protected?

All clinical trials are regulated by the Medicines Act 1975 and the Medicines (Clinical Trials) (Amendment) Regulations 1998. In addition, research studies conducted in KTPH must seek ethics approval from an independent ethics committee called the Domain Specific Review Boards (DSRB). The committee includes medical doctors, paramedical staff, statisticians and volunteers from the public who collectively review all research proposals. The rights, safety and wellbeing of trial participants are the most important considerations and prevail over interests of science and society.
Before a trial is initiated, a detailed research proposal is to be submitted for ethical review by the DSRB. As a clinical trial progresses, study status reports will be submitted periodically to the DSRB and if necessary, random audits will be conducted to ensure protocol compliance. Individual participants’ names will not be reported to protect participants’ confidentiality.

What should people consider before participating in a trial?

Before participating in a trial, potential participants should know as much as possible about the trial. He/she should feel comfortable raising questions and concerns about the trial to the study team. Below are some questions that can help in understanding a trial before participating:

  • What is the purpose of the study?
  • Why do researchers believe the new treatment being studied may be effective, or more effective than standard treatment? Has it been tested before?
  • What kinds of tests and treatments are involved?
  • Were there any serious side effects in pre-clinical studies?
  • How do the possible risks, side effects and benefits in the study compare with my current treatment?
  • What minor side effects should I be aware of?
  • How might this trial affect my daily life?
  • How long will the trial last?
  • How will I know that the treatment is effective? – Will results of the trials be provided to me?
  • Will I be informed of updates in any new available treatment?
  • Will I need to be hospitalised?
  • Who will pay for the treatment?
  • Will I be reimbursed for expenses?
  • Can I withdraw from the trial after it has begun?
  • Will I be denied medical care if I withdraw from trials?

Who pays for clinical research?

The hospital funds promising clinical studies initiated by doctors as part of our ongoing commitment to promote, develop and provide health-related services that will benefit the Singapore community. Additional funding may come from government organisations, such as National Research Foundation (NRF), National Medical Research Council (NMRC) or private industry (via pharmaceutical and biotech companies).