Australia offers sponsor experienced and well-established clinical research sites, principal investigators and research nurses.
Given that the industry is wellestablished there is also much experience and talent in the clinical research employment sector. China presents some unique opportunities and challenges. The country is achieving positive momentum in approvals for drugs meeting urgent needs even as some data quality and compliance issues are still being worked out. The approval timeline remains long and highly variable months.
These timelines could decrease as the current backlog of medicines awaiting approval is clearing. China can still seem a bit daunting to some, but with early engagement, broadbased feasibility analysis and flexible resourcing modelsthese and other challenges can be overcome. What is BEST is what works, allowing for strategic needs that move faster than a current partner set-up can keep apace of. BEST models integrate different partners as well as different models of delivery that range from resource augmentation, through project-based outsourcing to high accountability joint-investment partnerships.
As these markets grow, an expanding list of stakeholders needs to be engaged in competition for the most advantageous sites. They can provide the local knowledge and insights required to identify the sites and investigators where the potential for rapid initiation and recruitment is highest.
We are at an exciting time in the history of clinical development in this region. APAC is increasingly seen as being integral to global trial success, and markets such as Japan are more often being considered in the first wave of launches for innovative drugs.
This progression has been long in the making. The reality is that this is a journey on a twoway street, one that requires effort from all parties including sponsors, CROs, regulators and investigators across oceans, time zones and geographies. A highly evolved understanding and openness to working with differences across countries as diverse as China and Japan, for example, implies not just knowing the context in which all teams operate, but how to be mutually-adaptive to the need for both local sensitivity and global consistency. BioSpectrum India.
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Monday, 23 September Toggle navigation. Sebastian Bather President, APAC and Japan at inVentiv Health With drug sponsors increasingly challenged to recruit sufficient numbers of patients to run complex, global clinical trials in key therapeutic areas — and to conduct those trials efficiently and cost-effectively — the Japan and the Asia-Pacific region APAC offers an expanding array of opportunities for clinical development and commercialization activity.
For example: Invested in enhanced capabilities for cross-border project management, clinical monitoringthat understands the individual country nuances and regulations. Provideon the ground feasibility resources, on top of the standard globally-available data-bases, and in our ability to hone our insight into specific clinical trial sites and principal investigators in key therapeutic areas such as oncology, respiratory and central nervous system disorders. Established dedicated study start-up teams in key markets to bring local expertise to bear in tandem with our global methodologies, and to move more rapidly through feasibility to study initiation and to accelerate patient enrollment timelines.
Several items to consider when expanding into a new APAC country include: Japan Japan is investing heavily and systematically in developing open data and common standards for health technology assessment. Korea Korea attracts a very large number of global studies, partly because of sustained investment by public authorities in high quality, costeffective clinical trial infrastructure. Australia Australia offers sponsor experienced and well-established clinical research sites, principal investigators and research nurses. China China presents some unique opportunities and challenges.
A mix of Sponsor and Partner, multiple deliverymodels and systems, adapting quickly to changingdevelopment needs of all stakeholders and regions. Achieving more with no more; it is more than ameasure of operational productivity and cost, thecritical factor is unlocked value. Clarity that advances further than the usual notionsof RACIs and task matrices to work aligned to valueoutcomes, made easier when some elements can still be delivered in sponsor systems under sponsor control.
Becoming Truly Global We are at an exciting time in the history of clinical development in this region. Please note that comments are moderated and are generally published if they are on-topic and not abusive. Please click here to Sign-in or Sign-up. May Be. To that end, it is critical that biopharms leverage CRO partners that have global capability support, but also strong localized presence and expertise in the targeted regions. CROs that possess dedicated resourcing and staffing in emerging markets are better able to use strategic planning to address various global trial challenges, particularly those related to regulatory and oversight requirements.
For instance, having robust processes in place for regulatory intelligence gathering can help local clinical teams stay current with any changes or revisions that could affect their studies.
CROs maintaining fluent communications with the regulatory agencies is also crucial to these efforts. Discussing protocol reviews directly with regulators can ensure ongoing compliance with their requirements and also aid in the development of the regulatory plan during study start-up. When planning a global trial, there are several unique ethical and scientific issues that should be considered in each market.
Not all clinical trial programs are able to commit to providing the drug after the study. In certain regions such as Latin America, the acceptability of placebo-controlled trials has been dwindling. An increasing number of countries have implemented more stringent data protection laws in recent years. Additionally, social issues should be carefully evaluated when exploring global trials.
For example, in the Philippines, a predominately Catholic country, there have been notable issues concerning contraception requirements in clinical trials, which have affected the design of global-run studies there. Ethics guidelines in certain countries have also posed difficulties in developing and implementing pediatric studies. When initiating global sites, it is crucial to assess financial-related issues. For example, in Latin America, there is more transparency today involving site contract agreements.
CROs are now required, in some cases, to submit contract templates.
In addition, hospital and site administrators have greater visibility into the details of site contacts and are more involved in their review. These trends point to the increased likelihood of longer contract negotiation timelines and, thus, potential delays in study start-up. Therefore, strategies in Latin America should focus on beginning the site activation process as early as possible.
The introduction of new insurance requirements in emerging markets has also created challenges. For instance, in Latin America, companies traditionally were able to secure global insurance and use it for all their studies in the region. Today, however, organizations must first ensure that each site contract can be executed in the individual countries and comply with the local rules. Addressing these extra steps requires the involvement of local teams to ensure that sites in each country are able to qualify. Challenges in language translation have generally lessened in recent years in developing markets as global expertise in managing these activities has grown, and arrangements with language service providers are now well-established.
Nevertheless, the planning of translation activities is critical when setting up trials, as are the related communication approaches. It is important to allot time for quality control reviews of translation documents. In the case of informed consent forms, sites must ensure that patients will be able to read and clearly understand the document. That may require adjusting certain wording to better fit the particular language variation in the country.
Clinical Research in Asia. Opportunities and Challenges. A volume in Woodhead Publishing Series in Biomedicine. Book • Authors: Umakanta Sahoo. There are few clearer illustrations of the rapid changes impacting the pharmaceutical sector than the clinical trials industry. Clinical trials were once undertaken.
For example, the mention of a specific adverse event may need to be worded differently in one country compared to another. Local CRO staff can help in implementing these sorts of subtleties where necessary. Many of the challenges in clinical trial globalization can be overcome by ensuring that the correct infrastructure is in place and logistics strategies are sound. In the area of data management, global CROs are able to leverage their own integrated clinical trial management systems when conducting trials in emerging markets.
Providing a single technology capsule allows for much more seamless and efficient data collection compared to trials run by smaller domestic CROs that often feature multiple disparate systems. Setting up laboratory testing arrangements is another key infrastructure component of global trials.
Larger-sized CROs tend to work closely with international preferred vendors for sample testing in global studies. CROs, in many cases, can provide their clients with a single vendor based locally in the country targeted. In these arrangements, biopharms can more easily access the global infrastructure, and take advantage of a very clear communication path and process for managing their global trials. Partnering with an international vendor can also help to avoid the logistical issues in biological sample shipping that exist in many developing nations.
In addition, many emerging regions do not allow shipping from the United States to the investigative site. Early planning and project management is essential in navigating the various logistical challenges in global trials. These issues can potentially delay the initiation of site activation and patient enrollment, among other start-up activities. Early planning should involve preparing the necessary paperwork for the study, particularly pertaining to the investigative and comparator drugs; securing the drug import license; and planning all the shipments.
When clinical trial supplies are imported into a country, it is important for CRO staff to work with the broker on ensuring that all invoices, permissions, and documentation are in place to clear customs. In certain emerging regions, clinical research is still a relatively young field, and, therefore, sites in these locations generally have less experience running trials than those in more mature markets. In these cases, there is a need for sites to be more closely managed. The capabilities of local investigators and sites must be carefully reviewed and detailed monitoring plans established.
Also critical is the ability of clinical research associates CRAs and clinical monitoring associates CMAs to cultivate strong relationships with the less-seasoned sites, including the development of innovative strategies in communication, training and education. Global biopharms and CROs must approach sites in emerging countries differently than they do for those in the United States or Western Europe, adjusting their strategies based on the site-specific needs in each country.
In some regions, due to site saturation, there has been a noticeable drop in the number of hospitals and clinics participating in clinical trials. CROs need to continue to work closely with their clients in developing more sites in emerging markets to meet the growing demand. In addition to his CRO experience, Mr. He also established the first Singapore project for the same global CRO.
Email: gtierney incresearch.