Decentralized Clinical Trials in APAC Here to Stay

Around the Globe

Serene Ong
Marken APAC

Gaurang Majmudar
Marken

he face of clinical trials has been changing rapidly, and while decentralized clinical trials have been explored by the industry for many years, the COVID-19 pandemic has exponentially accelerated the shift towards such trials with increased urgency. The most dramatic shift in this direction has been on logistical and at-home services, as they were needed to support the ongoing studies.

Unanticipated deviations to clinical research protocols became unavoidable, as subjects were unable to attend study visits due to travel restrictions, clinic closures, and quarantine requirements. Regulatory bodies around the world were forced to quickly revise their regulations or guidances to minimize disruptions to clinical research.

Quickly Evolving Regulatory Landscape

New guidance documents were rapidly issued by national regulatory bodies seeking to balance patient safety with continued access to trial medications. Barriers to participation and acceptance of remote healthcare have been reduced to ensure patients can still receive their much-needed medications via direct-to-patient delivery; home visits helped prevent health risks.

A technical guidance paper was published by the World Health Organization (WHO) in April 2020 on strengthening health systems against COVID-19. This paper recognized telemedicine as an alternative model for delivery-of-care to ensure the continuity of essential healthcare services.

In Singapore, the Health Sciences Authority (HSA) also issued guidance (revised July 2020) to provide general considerations to sponsors and investigators to ensure the safety of trial participants, compliance with the clinical trials regulations, and ICH GCP (R2) Guidelines to minimize risks to trial integrity.

Regional travel restrictions were imposed and had a major impact on the National Cancer Centre Singapore, as many of its patients on trials come from other SEA countries (Malaysia, Indonesia, the Philippines, and Vietnam). The implementation of telemedicine, local laboratories and IP (Investigational Product) delivery were all utilized to mitigate the impact of these restrictions.

Adapting to the Unknown

When COVID-19 first emerged in early 2020, many areas in China went into quarantine overnight and strict travel restrictions were imposed. There were also numerous flight delays and airline cancellations into and out of China. Pharmaceutical companies, central labs, and clinical research organizations all risked losing clinical trial patients who could not travel to the investigator sites. Regulatory, compliance, quality, and shipping challenges related to import, export, and customs clearance were also prevalent. Patients and investigators faced the prospect of not receiving the clinical trial medications upon which they relied.

Many of these clinical trials companies turned to Direct to and from Patients (DTP/DFP) distribution to enable continuation of drug delivery to their patients. For example, to meet the increased demand, one decentralized solution provider quickly established a COVID-19 Rapid Response Team with dedicated experts, including Chinese speaking staff and resources to provide guidance and support to this region. They also had to work closely with airlines and local service providers (LSPs) to ensure timely delivery of shipments. With the rapid response set up, this provider successfully delivered more than 300 Direct-to-Patient shipments within the first month, allowing enrollment to continue and providing continuity for many clinical trial patients during that critical period.

Another successful implementation of DTP/DFP was in India, where home delivery of clinical trial medications was not previously available prior to the outbreak of COVID-19. However, given the critical need to keep patients in their clinical trials, the India government permitted DTP services to proceed. This was made possible thanks to the company’s well-established Standard Operating Procedures, data protection technology, and adherence to Good Distribution Practices (GDP) and Good Clinical Practices (GCP).

In addition, DTP shipments are now allowed in several other Asia Pacific (APAC) countries including Taiwan, South Korea, Japan, and Malaysia, and this list is growing as the pandemic moves into its second year.

Accelerating Home Healthcare Availability

There has been an equally dramatic shift in the acceptance of home healthcare (HHC) in clinical studies throughout this period. Home healthcare has been accepted widely in the commercial (licensed) medicines and general healthcare space throughout the APAC region in countries such as South Korea, China, India, and Malaysia. The inclusion in clinical trials has been widely accepted in the US and Europe for many years; however, in APAC it is a newer phenomenon – particularly in South-East Asia (SEA) countries.

Regulations have been key to the greater use of decentralization. For direct-to-patient deliveries, the regulations were much clearer in the early part of the pandemic as illustrated by the early responses by logistics providers.

For home healthcare, the guidance has not been as uniform, or clear, from the regulators. Each country in the APAC region has different regulations on this aspect of decentralization and how it may be delivered. As the demand for HHC in the region to be included in clinical studies is growing rapidly, provider organizations must deliver services by understanding the local regulations and designing services that are compliant. As an example, the DTP and HHC in Japan, China, India, Malaysia, and Korea are all governed by very different regulatory guidance, meaning an organization working across these countries must be agile and adaptable to deliver the same services across these jurisdictions.

Looking Ahead

Despite the relaxing restrictions as vaccinations increase and countries reopen and recover, the demand for decentralized trials continues to rise. We have seen the benefits of decentralization in supporting the patient during this traumatic time, so why go back to the way it was? HHC and DTP/DFP capabilities support a safe and staged recovery of clinical research activities and a new era of care delivery and improved quality of care. It has become a requirement in protocols as a way to keep patients in the study and, in many cases, may be the only option to keep a trial viable. The many benefits of decentralized trials include patient centricity. Reducing the burden on a patient participating in a clinical study will engage them better in the study and deliver a better experience for both patient and sponsor. At the simplest level, it is especially helpful for patients with mobility issues or who do not reside near a clinical trial site, which in turn helps with patient recruitment and enables clinical sites to access a larger patient population. Additionally, patient retention improves as fewer site visits decrease the burden for both patients and caregivers.

As we move towards increased demand for DTP/DFP, telemedicine, and incorporating more technology in clinical research, we need to ensure there is no reduction in the quality of medications being delivered or information being provided. Regulators are encouraging adoption of telemedicine to improve access to healthcare and the quality of patient outcomes, allowing patients in remote areas with urgent care needs to participate in clinical trials, too.

Logistics solutions providers will need to gear towards increasing patient care in the home, which can include shipping from a central depot or pharmacy, regional or local depots, and investigator sites. Other considerations include service delivery interfacing, data security, and regional regulatory differences.

There is no doubt that decentralized studies are here to stay, which will drive improvements in clinical trial recruitment, retention, and adherence. All stakeholders–from patients to sponsors–benefit as we continue to improve the patient experience.

Back to Issue