From hypothesis to treatment: perfecting clinical trials

25 November 2016

Dr Hilda Tsang (2006 Croucher Scholar; 2008 Croucher Fellow) has always been interested in medicine, studying Medical Genetics as part of her PhD and researching in the Division of Experimental Medicine at Imperial College London. She remains at Imperial College, where she now applies her knowledge to her role as the Cardiovascular Operations Manager for the Imperial Clinical Trials Unit (ICTU) in the School of Public Health.

Tsang has been in this role at the ICTU for almost three years, and despite its difference from her background in research, she thoroughly enjoys the work. 

Typically, Tsang explores the possibilities of at least five trial proposals at a time, while overseeing four or five live trials focused on a variety of illnesses, including heart conditions and heart surgery, as well as investigations into hypotension, high cholesterol, and diabetes. 

She oversees trials which explore a range of things, from heart transplants to mobile technology. For the most part, Tsang advises on the practicality of the trials, focusing how to make each trial more feasible, more deliverable, and less costly. Most of the studies are funded by the NHR or the British Heart Foundation (BHF), although a small number are commercially funded.

Each project has distinct stages, all of which Tsang is involved in, from the grant application, through the set-up period, the recruitment of patients, to close down and analysis. While the idea for the trial originates from another scientist, Tsang works in an academic unit, so her knowledge of research can be useful for certain aspects of her work, for instance, she assists in creating a protocol for each trial, which aims to cover all possible outcomes of the trials. 

Tsang enjoys working alongside a large number of people on a range of projects at one time. Within her unit there are three teams: operations, statistics, and database, and within each of these teams she works alongside clinical experts, ranging from experienced clinicians to junior doctors, basic scientists, and NHS workers. 

Tsang enjoys having the opportunity to work with the NHS and those in industry, something she had not experienced as a basic scientist. Working with such a range of teams on multiple projects at any one time has provided Tsang with extensive exposure, and transferrable knowledge and skills which she can apply to different studies.

SAMSON trial

Currently, Tsang is overseeing the Self-Assessment Method for Statin side-effects Or Nocebo (SAMSON) Trial, which she finds particularly compelling due to its use of mobile technology. The trial focuses on statins, a class of lipid-reducing medications used in treating cardiovascular disease, are a controversial topic within the UK media, facing much negative press. 

However, researchers are now fighting the negative image of the use of statins. Dr Francis Dale of Imperial College designed the trial, in which fifty participants who once took statins but stopped due to minor side effects which began within the first two weeks of taking the statins were recruited to try statins once again. 

Only those who have experienced minor, and not severe, side effects are allowed to be involved. The double-blind trial will last twelve months, and involves patients taking statins for four months, taking a placebo for four months, and taking nothing for four months. 

Dr Hilda Tsang

The team behind the trial designed a simple and easy to use mobile application which patients use every day, confirming whether or not they took the drug as well as scoring their how many side effect symptoms they have experienced on a score of 0 - 100. 

The trial has two key aims, one being to assess the volume of side effects experienced by the patients due to statins compared to the volume of psychological side effects, which can be done by charting and comparing the patients’ monthly scores. The second aim hinges somewhat on the success of the trial, after which the team hopes to develop an open source resource in the form of a mobile application which can be used by other researchers to undertake similar studies, or can be used for clinical purposes. 

Tsang has recently received an increased number of research proposals which incorporate mobile technology, and this is an area she is very interested in, because it allows researchers to not only collect more data but also incorporate more creativity into their trials.

From experiments to trials

Tsang is also currently overseeing another BHF funded study, this time with a heart pacing specialist. The research is investigating a new method of pacing utilising existing devices, but modifying the pacing technique, allowing this treatment to be used on a group of patients who are not normally eligible for this type of treatment, including those with heart failure. It is hoped that a modification of the pacing method could be applied to this group of patients so that they could also benefit from the technology.

Despite finding herself in this role in part due to chance, Tsang thoroughly enjoys her work, which seems quite removed from the fields of her PhD and postdoc, which were lab-based and involved basic science, and offered little exposure to clinical research. 

Tsang says, “I enjoyed developing new methods in research, but I am not very good at developing new research ideas, and you need that to progress in your academic career. At the same time, I think that I have more skills to offer than just laboratory work, so I thought about doing something different and started to explore what else was out there.” 

This prompted her to apply for jobs in clinical research fields, in an attempt both to try something new and in the hope that she would be good at it. Tsang was offered a job managing a cardiac stem cell trial, which was a steep learning curve, in part due to both her limited experience of clinical trials, and as this trial was a complex, multinational trial. 

Her work as a stem cell biologist during her postdoctoral research was useful in this case, as although the trial implementation, design, and delivery were foreign to her, the science was familiar. Not only did Tsang rise to the challenge of this role, but it served as a bridge to her current role in the cardiovascular unit.

Challenges

Tsang has a background in medical science, having completed her PhD at the University of Cambridge with the support of the Croucher Foundation. Her PhD focused on cell signalling and a rare condition called spastic paraplegia, an illness similar to motor neurone disease. 

She continued to explore cell signalling during her postdoctoral research at Imperial College, examining the BMP signaling pathway, a long series of cells which contain microtubials, along which vesicles carrying the cell’s signals are transported. The aim of this project was to find out if interfering with this machinery could promote certain cell signalling which might reverse the disease process.

Her current role marks a dramatic change to her previous research, and Tsang explained that while basic science allows for scientists to be very creative and have few limitations imposed on them in terms of what experiments they could conduct, clinical trials involve lots of practical limitations, which makes her work very challenging. 

However, she enjoys the challenge, believing that she is better suited to solving practical problems. Currently, Tsang has no plans to leave her role at the Imperial Clinical Trials Unit, as she thoroughly enjoys working there, “I really like what I am doing. Sometimes, it is very challenging, however what I like about this work compared to what I have done previously is that each project has distinct stages in its life cycle. There are lots of different conditions on our portfolio, and I really enjoy the diversity of the research.” 

She plans on continuing to work in the Cardiovascular unit in particular, “In the past three years I have gotten so much exposure to this disease area, that I think it would be a shame if I changed the specific area now and could no longer use that knowledge.” In the future, Tsang would like to develop her knowledge of and become more informed about the use of mobile technology in a clinical setting, feeling that this is a promising area for development.

Dr Hilda Tsang studied Biology during her undergraduate degree at the University of York, before moving to Cambridge, where she did her PhD in Medical Genetics, supported by the Croucher Foundation. She then moved again to the Division of Experimental Medicine at Imperial College London for her post-doctoral research. She has remained at Imperial College, where she is now the Cardiovascular Operations Manager for the Imperial Clinical Trials Unit (ICTU) at the School of Public Health in the Faculty of Medicine. Tsang received a Croucher Fellowship in 2008 and a Scholarship in 2006.

To view Tsang’s personal Croucher profile, please click here.