A discussion of the impact of a strategic alliance in to facilitate operational success at the clinical trial site level in Malaysia.
The success of a clinical trial is crucial in ensuring a drug is approved to be marketed and the process involves a significant amount of cost. The likelihood of a drug at Phase I making it all the way to the market tentatively has a 14% success rate.1,2 Therefore, it is critical for pharmaceutical companies to ensure that the planning and implementation of a clinical trial strategy is effective in order to obtain the desired results. There are many factors which can contribute to the successful conduct of clinical trial; such as, the selection of high-quality clinical sites and complexity of the clinical trials protocol as it plays a major role in determining the successful rate of the clinical trial. However, the most important factor in determining the success of a clinical trial lies in the co-operation and teamwork of all the stakeholders involved, such as the pharmaceutical organization, the CRO, the principal investigator and the clinical trial support team. In this article, the authors describe the impact of a Strategic Alliance (The ICR-CRM-IQVIA Network) in to facilitate operational success at the clinical trial site level in Malaysia. Pivotal success factors include enhanced site relationship, transparent communication channels, open information-sharing, and the on-going development of new processes and tools to overcome operational inefficiencies and challenges.
Regardless of the industry, business leaders agree that developing long term, mutually beneficial relationships, is critical to business success. Recognizing the importance of strategic alliance, ICR-CRM-IQVIA came into collaboration, with the goal of a site-centric, transparent, relationship-based commitment that empowers and facilitates operational improvements to clinical trials. Critical components, such as tangible improvements to clinical trial operations between the stakeholders and the trial sites, are among the key success factors of this collaboration. In the context of strategic alliance, it can be defined as an agreement between firms to do business together in ways that go beyond normal company-to-company dealings but fall short of a merger or a full partnership.3
Clinical Research Malaysia (CRM) is a provider of clinical research services that offers site management services to investigators conducting clinical research within hospitals and was established by the Malaysian government to entice sponsors to conduct trials in the country. CRM has a team of approximately 130 trained study coordinators based at various sites conducting industry sponsored research.4 The Institute of Clinical Research (ICR) functions as the clinical research arm of the Ministry of Health (MOH) Malaysia to support and facilitate activities in its hospitals. In this collaboration, the major role of ICR is to provide trained, expert investigators and site availability in order to coordinate industry-sponsored research in the Ministry’s facilities.5 IQVIA is a global provider of advanced analytics, technology solutions and contract research services to the life sciences industry, from drug clinical development to commercialization.
Since the collaboration began in 2013, a network of sites has been established under the ICR-CRM-IQVIA network. In the beginning, six MOH hospitals have been identified and selected to join the program based on rigorous criteria, among them the capability and capacity of the sites, and the commitment to operational efficiency and improvement. Currently, the network has expanded to a total of 18 MOH hospitals.
To ensure the success of the network in maximizing the research productivity, dedicated alliance managers from CRM and IQVIA were assigned to manage the relationships and performance of these sites. Alliance managers also act as ambassadors for their assigned sites, supporting business development and support system process improvement. The alliance managers maintain regular communication with assigned sites on:
It was that noted from the collaboration, that the performance of the clinical trial sites within this network have improved tremendously from 2016 till 2019. Among them are:
Figure 1: Percentage of Patient Contribution from ICR-CRM-IQVIA network sites into IQVIA managed studies in Malaysia. Source data from IQVIA
Figure 2: Percentage of Patient Enrollment of studies from ICR-CRM-IQVIA network. Source data from IQVIA
Figure 3: Clinical Trial Agreement Timeline (from initial draft to executed contract) of studies in ICR-CRM-IQVIA network. Source data from IQVIA
In order for the strategic collaboration to sustain a competitive advantage in clinical trial, the network needs to be ready for more challenges for the future. Priority remains for the continued focus of the network to be the center of excellence with successful achievement of the performance indicators, however, maintaining high performance is more challenging than attaining it.
It is clear that advancing technology and its integration in the way it implemented in clinical trials will be the focus in coming years. The network sites must be ready to embrace and adopt new clinical trial technology such as adapting electronic tools and methods in clinical trial activities. The network and its ability to generate and collaborate on innovative ideas rooted in the reality of clinical practice will be critical to partners in understanding where technology gaps are and how to best fill those gaps. For instance, there have been active discussions around remote, decentralized, and virtual trials, especially in recent times. The required technology adaptions include and are not limited to electronic informed consent, telemedicine, electronic filing of study documents, etc. IQVIA has the ability to front this technology but would require support of CRM and ICR for successful implementation at the site level. CRM and ICR would have the critical role in evaluating the technology from a local perspective and in addressing the opportunities and possible limitations.
The success of the clinical trial conduct proves that the importance of the strategic alliance’s role for the sustainable competitive advantage and stimulate further conceptualization and research on the subject.6 The advantage of the strategic alliance is not limited to the improvement of the organization performance, but it can also be a method for significant learning and knowledge acquiring, which eventually leads to sustainable competitive advantages for all partners. Regardless of the challenges ahead, what is definite is that relationships are the foundation upon which this network is built on and the strength of this network will continue in sustaining it long into the future.
Abdul Haq Nurhaizan is the Alliance Manager; and Joanne Yeoh is the Clinical Operation Head of Department, both of Clinical Research Malaysia. Yong Li Fern is the Associate Director, Patient & Site Services, SEA R&D Solutions; and Robert Kerle is the Head of R&D Solutions, Southeast Asia, both of IQVIA.