Pharma Focus Asia
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FUTURE OF CLINICAL TRIALS IN APAC

Oracle’s initiative

Jeyaseelan Jeyaraj (Jey), Senior Director, Solutions Consulting, Asia Pacific, Oracle Life Sciences Global Business Unit

What will the future of clinical trials be in the next few years?

We are seeing pharma shift to explore newer clinical trial models and technologies. For example, many are looking at decentralised trials as an option to open the pool of potential candidates and to make trials more accessible and equitable for more people. In the US, the retail pharmacy model is also expanding according to Forbes1, which notes during the pandemic retail pharmacies provided vaccinations and has opened the door for more services.

We continue to see the expansion of the use of sources such as electronic health records (EHR) and connected devices that will enable companies to collect larger quantities of anonymous, highquality real-world evidence. Applying AI and machine learning to this data will have a tremendous impact on the market, especially in areas like pharmacovigilance. As new treatments come to market faster, patients and providers will further utilise these advancements to have more accurate safety information.

We expect the emergence of virtual CROs and their use of platform technology to address the demands of many new clinical trials contracted in Asia. Overall we see clinical trial recruitment in the region increasing faster than in Europe, North America, and Australia. According to “Clinical trials in Asia: A World Health Organization database study” 2there has recently been a seven-fold increase in the number of registered clinical trials in Asia. More trials were registered in Japan than in any other Asian country (30.8 per cent). Lower trial costs and a large patient pool may be key contributors to this increase – technology will also be a major factor in the success of these trials.

Organisations that strike the balance of futureforward technology and patient-centric models will have a greater chance of success and in taking a leading position in the industry.

How will real-world data (RWD) impact clinical trials?

Real-world data (RWD) will be critical in decisionmaking. The insights learned from this data combined with clinical research data can help shape drug companies’ approach to all aspects of the business including discovery, understanding safety in real-world conditions, go-to-market strategies, and how they run their clinical trials. As noted previously, sources like EHRs and connected devices will also enable companies to collect larger quantities of high-quality real-world evidence to better inform clinical trials.

What industry trends will we see specifically in APAC?

According to recent reports34, APAC continues to be a promising region for clinical trials. This is an opportunity for sponsors who are looking to capitalise on growth and for CROs who are emerging in the market. We expect that as this growth continues companies will turn to innovative platform technologies that can support all aspects of clinical trials and provide cost-effective models that bring value. This growth could also bring more cross-border studies and collaborations as sponsors look for larger pools of participants. According to “Growth opportunities: The clinical trials landscape of Asia-Pacific”5 in APAC, decentralised Phase I trials grew 60 per cent between 2017 and 2022, compared to an overall average of 10-20 per cent. APAC also accounted for the highest usage of in-home devices for oracle in any region in 2022.

What do companies need to do to adopt a more “consumer-centric” approach to patient care and engagement?

There needs to be a shift change within organisations to move toward a consumer-centric model where the patient has options relative to their participation in a trial. Some examples include enabling patients to remotely provide intake information, wearing sensor devices to convey clinical data, and sharing feedback via tele-visits. Leadership has to be willing to consider a new way of doing things and support these types of changes. COVID-19 was a changing force for many organisations to conduct trials differently.

What is the biggest roadblock to achieving better patient engagement?

One of the biggest challenges with patient engagement is accessibility. Many patients don’t have proximity to the trial site which creates both recruitment and engagement issues. However, this is being addressed in many ways with the new models of decentralised clinical trials. For example, electronic patient-recorded outcomes via a wearable device make it easier to collect data from a patient when they are at home, and electronic engagement tools such as chatbots make it very easy and efficient for patients to engage with their caregivers.

The pandemic accelerated the adoption of several different approaches to clinical trials. In APAC, which of these approaches is taking hold? What is the biggest trend, challenge, or market factor that you are tracking?

The past several years challenged the status quo and catalysed the adoption of a technology-enabled ‘patient-centric’ decentralised clinical trials model. The reality of this shift has led to most of the industry planning on continuing to implement newer clinical trial models and technologies. Patient optionality now rules the day, and organisations must plan on giving patients the choice about how they participate in clinical trials – such as in-person, in a  ecentralised model, or a hybrid of both. This will continue to drive the changes in clinical trials and clinical trial models in the future.

Can you address the growth in CROs and the clinical trial market in Asia i.e. what is driving this growth and how will technology meet the demand?

As we have discussed publicly6, several factors are fueling this growth: local regulations in APAC countries continue to evolve and drive the need for “globallyaccepted” solutions to conduct clinical trials; growing health challenges in APAC, such as diabetes and hepatitis, are an impetus for more trials to be conducted; government funding is rising, and APAC is emerging as a cost-effective destination to conduct clinical research trials. Forward-thinking CROs are adopting purposebuilt technology that utilises a uniform platform to address the challenges and complexities of running clinical trials in a global economy. These will improve operational performance and differentiate themselves as the market becomes more competitive.

Speaking of clinical progress, diversity is a subject that hasn't been on the health agenda for very long. How do you see this affecting the regulatory framework and being more than simply a talking point?

Diversity in clinical trials is a complex issue. However, the more diverse the population pool, the more that diverse data could be used to inform researchers overall about differences amongst the various populations. Ensuring people  rom diverse backgrounds join clinical trials is key to advancing health equity. Participants in clinical trials should represent the patients that will use the medical products. This is important because people of different ages, genders, races, and ethnicities may react differently to certain medical products. If the pool of trial participants does not represent the individuals most affected by a particular disease, condition, or behavior, there is an increased likelihood of creating gaps in our understanding of diseases and conditions,preventive factors, and treatment effectiveness across populations.

In terms of diversity and its effect on the regulatory framework, it will be interesting to see how governing bodies choose to address it. During the COVID-19 pandemic, Oracle worked with the University of Oxford on a system that helps identify variants early on, so that healthcare providers can learn whether current vaccines are working against those strains and public health officials can better determine if hospitals will be overrun with new patients. In general, better information will contribute to a better public health policy. If new policies around public health are put into place, there will likely be changes made to the existing regulatory framework as it relates to clinical trials.

We will also see more data-based communication, so that data from wearable devices and home monitoring systems can be communicated to healthcare facilities. This two-way channel will also allow clinical trial researchers to expand their reach to communities that aren’t close to a clinical site, giving researchers access to a much more diverse pool of participants, and further information about these populations.

Access to trials may be hampered in many communities by factors like distance. Do you see the integration of remote trials as a feasible opportunity?

Yes, not only is it feasible but the onset of the COVID- 19 pandemic quickly established that some aspects of decentralised clinical trials could, in fact, work.With the right technology and infrastructure in place, patients can participate in trials without having to visit the site every time the site needs to collect a data point. As we’ve discussed elsewhere, the emergence of electronic patient-reported outcomes, such as with wearables and other devices, paired with better communication infrastructure such as chatbots can provide a better and more efficient experience than patients have under traditional clinical trial models.

Another current issue, health equity, has diverse definitions around the world. What is health equity, and how is Oracle Life Sciences defining and pursuing it across the Asia Pacific?

Health equity in clinical trials refers to the fair and just inclusion of diverse populations in the design, implementation, and analysis of clinical research studies. Historically, clinical trials have not always included diverse populations, particularly people from underrepresented communities, which can limit the generalisability and applicability of the research findings.

There are several reasons why health equity in clinical trials is important. First, diverse populations may have different responses to medical interventions and treatments, and by not including them in clinical trials, we may miss important differences that could impact patient outcomes. Additionally, by excluding underrepresented populations, we may perpetuate health disparities and worsen existing health inequities.

In addition to recruitment, researchers can also work to ensure that their study designs and protocols are inclusive and accessible to all participants. For example, they may need to consider factors such as transportation, childcare, and language barriers when designing study procedures. They may also need to be flexible in their approach to accommodate individual participant needs.

With smaller biotech companies now receiving the majority of FDA approvals  and maybe having fewer resources to commit to issues like clinical trial diversity, how much of an impact can Oracle Life Sciences initiative really have?

Ensuring clinical trial diversity is critical to advancing healthcare equity and providing the best possible care for all patients. Biotech companies, regardless of their size, have a responsibility to prioritise diversity in their clinical trials

Here are some ways to overcome the challenge of limited resources:.

Collaborate with patient advocacy groups: Biotech companies can partner with patient advocacy groups to identify diverse patient populations and recruit them for clinical trials. These groups can also help companies understand the unique healthcare needs and experiences of underrepresented populations.

Leverage technology: Biotech companies can use technology to streamline the clinical trial process, reduce costs, and reach a more diverse patient population. For example, virtual clinical trials, which allow patients to participate in trials from their homes, can help overcome geographical barriers and increase participation from underrepresented populations.

Incorporate diversity into trial design: Biotech companies can design their clinical trials with diversity in mind. This means considering factors such as race, ethnicity, age, gender, sexual orientation, and socioeconomic status when selecting study participants.

How much is the industry's effort to increase the number of clinical trials hampered by issues with pricing and market access for novel products?

The industry’s effort to increase the number of clinical trials is not hampered but rather evolving. We are already seeing a greater interest from pharmas, CROs, and sites for a technology platform that can enable trials to be set up and conducted more quickly and efficiently. Over time, at Oracle, we hope our technology will contribute to the number of trials increasing. We recognise that healthcare, including clinical trials, is very complex, but with easier-to-use systems, we believe we can increase participation rates which can help lead to better outcomes7.

There is a lot of anticipation and excitement surrounding CAR-T, but how can you balance patients' expectations with the current scientific landscape? 

These are complex problems that healthcare professionals and researchers are  trying to solve. We support various discovery processes with our technologies. We are hopeful that as technology evolves and access to data increases, therapies and drugs will come to fruition more quickly to help those in need

References:

1 Retail pharmacies add new services as specialty drugs take greater role, Forbes May 2, 2023 - https://www.forbes.com/sites/brucejapsen/2023/05/02/retail-pharmacies-add-newservices-as-specialty-drugs-take-greater-role/?sh=45e0beead2bb
2 “Clinical Trials in Asia: A World Health Organization database study” 2019 - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6647899/. Oracle is referencing this study under the Creative Commons License: https://creativecommons.org/licenses/by-nc-sa/3.0/igo/
3 APAC As a Clinical Trial Powerhouse, Informa, November 2022 - https://invivo.pharmaintelligence.informa.com/IV146738/APAC-As-A-Clinical-Trial-Powerhouse
4 “Growth opportunities: The clinical trials landscape of Asia-Pacific” Clinical Trials Arena, January 2023 - https://www.clinicaltrialsarena.com/sponsored/growth-opportunities-theclinical-trials-landscape-of-asia-pacific/
5 “Growth opportunities: The clinical trials landscape of Asia-Pacific” Clinical Trials Arena, January 2023 - https://www.clinicaltrialsarena.com/sponsored/growth-opportunities-theclinical-trials-landscape-of-asia-pacific/
6 “The CRO market in APAC is heating up”, Oracle blog, February 2022 - https://blogs.oracle.com/health-sciences/post/the-cro-market-in-asia-pacific-is-heating-up-clinixir-is-readyfor-growth-with-clinical-one
7 “Larry Ellison outlines how Oracle can help shape a new future in healthcare” Oracle Blog, June 2022 - https://blogs.oracle.com/healthcare/post/larry-ellison-oracle-shape-futurehealthcare

--Issue 63--

Author Bio

Jeyaseelan Jeyaraj (Jey)

Jeyaseelan Jeyaraj (Jey) is a recognised Digital Health Strategist on addressing the challenges facing the global Healthcare Life Sciences industry and prospects for improving patient outcomes through better use of data and information. Jey brings his 20 plus years of broad consulting experience with Healthcare Providers, Public Health Pharmaceutical R&D that spans biotech, pharma and CRO.

Jey is the President of the Healthcare Information and Management Systems Society (HIMSS) India chapter. He was the member of the drafting committee for Digital Health Standards, National Accreditation Board for Hospitals Healthcare Providers (NABH) in India. He has published several papers and articles on Digital Health technologies. Jey has completed Post Graduate Program in Management from University of California (ULCA) Anderson School of Management. Jey is a frequent speaker about healthcare, biopharmaceutical trends and strategy in industry conferences. Jey is the recipient of CXO Health Excellence Award 2021 and recognised as the Top 50 Strategists in Healthcare.

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