Singapore in a good position to be a hub for clinical studies

Singapore's status as a travel hub can enhance its attractiveness to recruit more study participants in clinical trials.

Singapore has always prided itself as a regional or even global hub in many areas from aviation to international financing and even a hub for legal services.

However, in more recent years, there appears to be an increased focus around trying to establish Singapore as a hub for conduct of clinical trials and clinical studies. This is especially so following COVID where countries have been trying to look into encouraging more clinical trials to be conducted in their countries so that they can have firsthand information on the drug being developed or tap into the information generated through such clinical studies for potential joint development of vaccines or COVID therapeutic products.  

In this article, we will explore how Singapore can leverage both external and internal factors to develop such a hub for the region or even potentially at a global scale.

Increased focus on diverse ethnicity representation in trial participants 
COVID has witnessed the possibility of accelerated development of vaccines that can still be relatively safe and efficacious notwithstanding a shorter time for development and trials. However, notwithstanding the quick pathway to the development of the vaccines, regulators have remained slow in recommending the vaccines into the general population.

One of the potential reasons for such delay could be attributed to the fact that most of the clinical trial participants are not of the same ethnicity as the general population where the vaccines are to be applied, which in turn either makes it difficult for governments to convince the general population to take up the vaccines or the regulators from providing their approvals.  

Regulators in China have considered accepting clinical study results for phase I trials only where the study results are developed in countries where the ethnic make-up is similar to that in China. 

At first blush, this may not seem something that Singapore can play a role given that there are still a number of countries which have larger populations with similar ethnic make-up as China and which are more affiliated to China such as Hong Kong and Macau. However, most pharmaceutical companies should be aware that it is not easy to recruit study participants let alone for drugs that have a shorter pathway to development. 

Singapore can play a key role in providing a viable alternative to pharmaceutical companies to increase the probability of recruiting study participants that meet the above requirement.

Given that Singapore is a major hub for travellers, this can also enhance the attractiveness of Singapore in recruiting more study participants from outside of Singapore to participate in the clinical trials. Further, given that Singapore has a multi-ethnic population and society, if there are countries with regulators that also require certain ethnic diverse representations, Singapore can also fulfil to a certain extent the ethnic requirements.  

Pragmatic evolution of privacy laws 
For any research clinical studies, the collecting, use and disclosure of personal data is a key step and the regulation of such activities can have a pronounced effect on the manner in which the clinical studies can be carried out. In particular, depending on the type of patient that the clinical study requires, it is not always possible to obtain the consent of the study participants for the use or disclosure of their data.  

The costs of obtaining consents may outweigh the resources of running the trials. Another important aspect of clinical research is the need to ensure that the studies are double-blinded which will make satisfying some of the requirements under the Personal Data Protection Act 2012 (“PDPA”) difficult.

In Singapore, this difficulty was acknowledged quite promptly when the Personal Data Protection Commission (“PDPC”) issued a guideline in 2016 titled “Practical Guidance to Queries by Medical Research Institution” (“2016 Guideline”) to clarify what will constitute “impracticable.”

Further, the PDPC also recognises that there may be “exceptional circumstances where seeking the research subject’s consent would affect the validity or defeat the purposes of the research, in particular, where seeking consent would skew the research or introduce bias into the research such that no meaningful conclusions can be drawn.”

Section 4(6)(b) of the PDPA provides that the provisions of other written law prevail to the extent that any provision of Parts 3, 4, 5, 6, 6A and 6B is inconsistent with the provisions of that other written law. This will include the collection, use, disclosure or processing of personal data for a clinical study which is already covered under existing laws and regulations regulating clinical studies and research such as the Health Products (Clinical Trials) Regulations 2016, the Medicines (Clinical Trials) Regulations 2016 and the Human Biomedical Research Act 2015.

The above demonstrates the pragmatic approach that the PDPC takes towards research in Singapore.

Establishments of data exchanges to facilitate responsible use of data  
Finally, we would also wish to highlight that the Ministry of Health in Singapore, the Smart Nation and Digital Governance Office, Government Technology Agency and Synapxe have jointly developed TRUST, which is a health data exchange platform.

As mentioned in our earlier article “Medical data exchanges – a pipe dream or a nightmare?”, the TRUST can provide access to a rich amount of data sets that comprise largely of anonymised datasets relating to population, clinical data, lifestyle data, chronic disease screening data, and genomic data. Although TRUST currently remains more for the “public sector users and researchers from Singaporean public health institutions, institutes of higher learning and publicly funded institutions,” the infrastructure has been set up for future use of more cohesive and rich clinical study data sets.

Singapore as a regional or global hub for clinical studies 
Although it still remains to be seen whether Singapore can uphold itself as a hub for clinical studies, we do note that Singapore should be able to hold its stead in continuing driving towards such a target given that Singapore has the appropriate legal and data infrastructures to facilitate the conduct of such research.