A feasibility study is a crucial part of the clinical trial planning process. It enables sponsors and contract research organizations (CROs) to identify relevant clinicians who may be interested in a particular study.1-4 It also provides information on a site’s infrastructure, human resources and pool of eligible patients.1-4 Such information would help these companies strategize to meet timeliness, sample size requirements and regulatory and ethical conditions, as well as plan for potential challenges.
As clinical research involves multiple stakeholders, the presence of a single point of contact can improve communication, simplify processes, and reduce delays.5,6 This centralized approach is particularly useful for feasibility and site selection processes.6 In Malaysia, Clinical Research Malaysia (CRM), a not-for-profit government-owned organization established in 2012 to nurture an ecosystem that supports industry sponsored research in the country, offers sponsors and CROs a one-stop contact point for feasibility requests, access to the public hospital network of investigators, and other services.
This review will present the role of CRM’s centralized feasibility service in attracting sponsors and CROs to Malaysia.
The importance of rigorous feasibility studies
Pre-feasibility is information that is collected for preliminary, higher level assessments which allows sponsors and CROs to make decisions at a national and global level. Such enquiries include general questions on standard of care, drug registration status, epidemiology, and estimated patient pool of a particular therapeutic indication. A full feasibility study is a complete documentation of individual sites which may include a confidential disclosure agreement, protocol synopsis and site assessment questionnaire.
About 35% of delays in clinical trials are attributed to patient recruitment with one in five investigators unable to recruit a single patient.4 As non-active or under-performing trial sites can increase the cost of conducting a clinical trial by 20% or more,7 rigorous feasibility studies conducted in multiple centres are recommended.8 But conducting thorough feasibility assessments and selecting appropriate sites may be time consuming, and delay in these preliminary processes will jeopardise study milestones.7 Therefore, if feasibility processes in individual countries can be centralized with a single point of contact for sponsors and CROs, delays and redundancies may be avoided.5,6
Leveraging the strength of a nationwide access to public hospitals
One of the challenges in conducting feasibility studies is maintaining an updated database of principal investigators. The bulk of studies in Malaysia are conducted in government hospitals where doctors are transferred periodically. Therefore, data built on individual company databases can be outdated, thus misguiding and delaying feasibility approaches.
In Malaysia, CRM is the common link for various stakeholders which include sponsors, CROs, private and public doctors from universities, health clinics and hospitals, as well as the regulatory agencies and ethics committees. It is a centralized government-owned body that manages and overlooks Malaysia’s entire clinical research ecosystem.9 The detailed objectives of CRM are discussed in a prior article.10
As a single point of contact for sponsors and CROs and with presence in 33 clinical research centres within public hospitals throughout the country, CRM is vital in streamlining and accelerating feasibility studies in Malaysia.
Evolving to offer complimentary, centralized feasibility management
As CRM receives a variety of enquiries (Table 1) including pre-feasibility and full feasibility requests across all clinical therapeutic areas from both sponsors (pharma, medical device, biotech) and CROs worldwide, the Ministry of Health, Malaysia through CRM, established a centralized feasibility service. This service which is offered complimentary to sponsors and CROs, capitalizes on a comprehensive updated internal database of investigators, and enables outreach to a wider range of investigators and sites.
Previously, the sponsors and CROs conducted their own feasibility assessments and contacted individual sites on their own.11 Separate databases based on a company’s own experience, may not always be updated, and information such as transfer of clinician, changes in site personnel, and regulatory changes may be missed.11
A centralized process leads to centralized knowledge of the research environment which benefits CROs and sponsors engaging the service. A central database which incorporates data on a site’s performance and experience in recruitment and compliance provides more insight into how the site may perform in future trials.1,7 And as a single point of contact, the standardized processes lead to streamlined communications which reduces delay and confusion on the ground. As a result, the turnaround time is shorter than if a sponsor or CRO were to approach individually.
As CRM has a strong network, good rapport with investigators, and is familiar with ground level capacities of sites, poor site selection is less likely. Sites are mapped according to disease to enable the right sites to be approached for a specific patient pool in future. The sites are also mapped to track investigators who were overwhelmed, conducting competing trials, or transferred to ensure that only available investigators are contacted for upcoming trials. Such data would help narrow down the investigators who will give positive responses, thus reducing the time needed for feasibility studies.
When the feasibility team at CRM receives a feasibility questionnaire, a thorough analysis based on CRM’s central intelligence database is done (Figure 1). The questionnaire is then forwarded to relevant investigators. The process from the time CRM is approached to conduct a full feasibility assessment to the time CRM sends the completed questionnaire back to the company would take 5–10 working days. Pre-feasibility enquiries would take between one and five days depending on the complexity of the questions.
In addition, the feasibility specialists help interested potential investigators to address the queries and submit the completed feasibility questionnaire to the enquiring company. They provide technical consultation and organize meetings between investigators and CROs. Information is also compiled when investigators reject feasibility requests to understand their reasons for doing so.
Centralized service, a key attraction for sponsors and CROs
A centralized feasibility management service is a key attraction for sponsors and CROs,5 as the information from feasibility studies determines the suitability of Malaysia for a particular trial and promotes the capability of the sites to new international companies. The one-stop national feasibility model improves efficiency and timelines, as well as reduces the financial, administrative, and human resource burden of sponsors, CROs and investigators.
Sponsors and CROs are becoming more interested in Malaysia after the introduction of centralized feasibility, with full feasibility requests received by CRM increasing between 2015 and 2018 (Figure 2). There were also a five-fold increase in sponsors and an almost three-fold increase in CROs using CRM’s services in 2018 compared to 2014 (Figure 3). Majority of these companies are international companies (85%).5,11
In addition, feasibility assessments are complimentary, thus contributing to the overall cost-effectiveness of conducting a trial in Malaysia.
Clinical Research Malaysia’s model as a one-stop national center is a primary factor for the expansion in Malaysia’s clinical research industry in the last few years. The growth in sponsors and CROs is made possible through a centralized feasibility team coordinating and overseeing communications with sites. Thus, on a nationwide perspective, a centrally managed feasibility structure is an attractive alternative for sponsors and CROs looking to enhance efficiency and width of a feasibility outreach, avoid redundant processes and promote a more accurate assessment of Malaysia’s capabilities.
Noorzaihan Mat Radi (Senior Feasibility Specialist), Dr. Tan Bee Ying (Feasibility Specialist) and Audrey Ooi (Acting Head of Business Development) are from Clinical Research Malaysia.
- Johnson, O. An Evidence-Based Approach to Conducting Clinical Trial Feasibility Assessments. Clin. Invest. (Lond.). 5(5), 491–499 (2015).
- Orsmond, G.I. & Cohn, E.S. The Distinctive Features of a Feasibility Study: Objectives and Guiding Questions. OTJR. (Thorofare N J). 35(3), 169–77 (2015).
- Arain, M., Campbell, M.J., Cooper, C.L. & Lancaster, G.A. What is a Pilot or Feasibility Study? A Review of Current Practice and Editorial Policy. BMC. Med. Res. Methodol. 10, 67 (2010).
- Rajadhyaksha, V. Conducting Feasibilities in Clinical Trials: An Investment to Ensure a Good Study. Perspect. Clin. Res. 1(3), 106-9 (2010).
- Khairul, F.K., Ooi, A.J.A. & Tay, W.C. How a Centralized Feasibility Service Attracts Sponsors and Contract Research Organizations to Malaysia. Poster presented at the 53rd Drug Information Association Annual Meeting, Chicago US: Jun 18–22, 2017.
- Arenz, D., Siepmann, T. & Cornely, O.A. Centralized Management of Clinical Trial Feasibility Requests: A Single Center Database Analysis from 2008 to 2015. Clin. Invest. (Lond.). 6(1), 867–874 (2016).
- Temkar, P. Accelerating Study Start-Up: The Key to Avoiding Trial Delays. Clinical Researcher, 1 February 2017. Available at https://acrpnet.org/2017/02/01/accelerating-study-start-up-the-key-to-avoiding-trial-delays/, visited on 5 July 2019.
- Turner, C.L., Kolias, A.G. & Hutchinson, P.J. Feasibility Studies, Clinical Trials and Multicentre Collaboration. Acta Neurochir. (Wien). 159(1), 11–12 (2017).
- Society of Clinical Research Professionals Malaysia. A Guide to Conducting Clinical Trials in Malaysia (1st edition) 2016.
- Ooi A.J.A & Khalid K.F. Malaysia’s Clinical Research Ecosystem. Appl. Clin. Trials. 26(4), (2017). Available at http://www.appliedclinicaltrialsonline.com/malaysia-s-clinical-research-ecosystem-0, visited on 5 July 2019.
- Ooi, A.J.A & Khairul, F.K. A Unique Model to Accelerate Industry-Sponsored Research in Malaysia. Journal for Clinical Studies. 11(1), 24–27 (2019).
Source: Journal for Clinical Studies