Clinical Trials Centre Looks Ahead as it Celebrates 25 Years
New opportunities are on the horizon as the University of Hong Kong’s Clinical Trials Centre celebrates its 25th anniversary and eyes greater collaboration in the Greater Bay Area.
Building on its expertise, the centre is poised to aid the establishment of a Greater Bay Area International Clinical Trial Institute, which will act as a hub for clinical trials research in Hong Kong and southern China.
“With all this experience and know-how we can help to bring in industry as well as local and regional patients to test new drugs and new interventions,” said Professor Leung Wai Keung, a gastroenterologist and Chief Director of the HKU-CTC.
The government-led initiative will bring together the region’s clinicians and scientists, and expand the CTC’s catchment area to 20 to 30 million people, Professor Leung said.
In its current form, the HKU-CTC helps HKUMed’s investigators design, register and execute trials, offering resources including data analysis and laboratory support. It also operates a Phase 1 Clinical Trials Centre, a clinical laboratory and a pharmacy based at Queen Mary Hospital.
Since its founding, the HKU-CTC has facilitated 1,800 clinical trials ranging from vaccines to devices and Chinese medicines. It currently supports 100 investigators from HKUMed.
Through its strong industry links with more than 350 partners, it helps match pharmaceutical makers with suitable researchers to conduct drug trials. The HKU-CTC has participated in clinical trials for around 25% of the novel drugs approved by the US Food and Drug Administration.
Professor Leung, who is also Associate Dean (Research) at HKUMed first worked with the HKU-CTC when conducting his own research into gastric and colon cancers and inflammatory bowel disease.
As the HKU-CTC prepares to celebrate its anniversary, we asked Professor Leung to explain the ins and outs of clinical trials.
What is a clinical trial?
According to the US National Institutes of Health, it’s whether it involves human beings. Whether you intend to assign interventions prospectively to that individual and whether you assess the outcome of that treatment. And if the study is designed to evaluate the effect of the intervention on the participant and the effect can be a health-related biomedical or behavioural outcome. If you answer yes to any of these questions then it is a clinical trial.
Why are clinical trials important?
They’re very important because there are many new treatments coming up, new equipment, potential new interventions. Evaluating the effectiveness of that intervention requires a systematic and very structured protocol-driven design to systematically evaluate the outcome without any bias, and that’s also fair to the patient.
What are the steps in a clinical trial??
One of my interests is inflammatory bowel disease. There are many potential inflammatory mediators, or pathways that may work in controlling inflammation. If you identify a certain molecule or certain antibody that may work then first you have to have to look at the basic mechanisms in cell lines and animal studies before you bring it into humans. The first stage is where you assess the safety of the drug, so you require a Phase 1 study.
A Phase 1 study evaluates the product in healthy individuals and sometimes it could be in a patient. A Phase 1 study is used to identify potential side effects and to find the maximum tolerable dose of that molecule or that product in humans.
If you have no particular safety concerns in Phase 1, then you can bring it to next stage. Phase 2 is an early phase, usually dose-finding and is usually conducted on patients. Once you’ve identified the appropriate dose you bring it to that disease and test it. Phase 3 is usually a much more large-scale, randomised, multi-center control study, aiming for regulatory approval.
Who can take part in a clinical trial?
Basically, everyone can. You can be an investigator. You can be part of the research team. A research team is composed of a lot of people, including not only doctors, but research nurses, research assistants, a lot of administrators, technicians, laboratory technicians.
As a patient, you can also contribute to a clinical trial. Sometimes even volunteers can contribute, particularly for Phase 1 studies. Everyone, potentially, can contribute to clinical trials.
Is it hard to find people to take part in a trial?
For my area, inflammatory bowel disease, trials will typically exclude patients with any comorbid illnesses. If you have inflammatory bowel disease, ok. If you have a history of hepatitis, sorry. If you have a history of tuberculosis, sorry. Because the potential treatment may increase the risk of infection. If you have any history of cancer, sorry. Because we don’t know whether this treatment will potentially increase the risk of cancer recurrence. Trials usually have very stringent inclusion and exclusion criteria.
For some diseases like cancer, because it’s a fatal disease, it’s easier to recruit patients than some other diseases. This is because of the patients’ willingness and the availability of other treatment options.
How do you ensure patient safety?
All trials will potentially cause risk. Protecting the patient is something that is very crucial for clinical trials. There are guidelines called ‘Good Clinical Practice’, which all researchers should be familiar with. Patient safety is a priority.
Even if you’re testing a very experimental treatment, patients should be aware of the potential risk-benefit and the alternatives. All patients should sign an informed consent [and] be aware of the potential risks, benefits, and also be given enough time to think about whether to participate in the trial. This requires a lot of discussion and rapport-building between investigators and patients.
What are the benefits of taking part in a clinical trial?
For the patients, they can receive a potentially new and effective treatment. Usually when these drugs are developed, they have some preliminary data showing the drugs are effective in a certain group of patients and they want to test it in a clinical trial. That’s appealing, particularly for some diseases where there’s no effective treatment or if the patient has failed the conventional treatment.
For the medical community, they will find out if this treatment will be more effective than existing treatment, or safer than existing treatment. Whether it’s more effective, or safer, or cheaper, or faster than existing treatments. There are many potential benefits for researchers because they really want to test out whether a new treatment is actually better than the existing one.
What is the usual timeframe for a clinical trial?
From identifying a potential molecule to bringing a drug to market would definitely take 10 years at least. From molecule to Phase 3 trial sometimes can be as fast as a few years, except for COVID-19 vaccine and treatment.
If I want to run a clinical trial at Queen Mary testing a new drug, the first thing I have to do is draft a protocol, I then apply for funding and apply for ethics approval. And also I have to apply for clinical trial certificates from the Department of Health. This includes for using an existing drug or medication for off-label use. All of this takes time. Not to mention patient recruitment, patient follow-up and the outcome assessment, which would take time.
