The principles of developing, conducting, analysing and subsequently reporting clinical research are widely known.1- 3 However, the success of a clinical trial goes beyond these principles. It also requires a structured, viable and businesslike management of the whole process, without which trials may fail.4 A critical part of managing clinical trials is a solid, well thought out clinical trial budget.5 A successful budget to ensure a good quality clinical trial should not only entail careful detailing of costs that are in line with the trial protocol, but should also include a financial management system that executes this budget in an efficient, timely and transparent manner.
Some issues and challenges in formulating clinical trial budgets could be applicable when managing the finances during conduct of the trials. Examples include how to maintain audit trails and being abreast of billing processes, ensuring all costs have been encountered for, and management of residual monies. Though ultimately the responsibility of the principal investigators, the detailed construction of a clinical trial budget and its management places a huge burden on physicians (or researchers) who have to juggle clinical practice while overseeing the running of multiple clinical trials.
Reducing the Burden of Principal Investigators
Established in 2012, the main objectives of Clinical Research Malaysia (CRM) are to effectively increase the speed, reliability and quality in delivery of outcomes of clinical trials conducted within the country. This is in line with the Malaysian government’s vision to enhance the country’s placing among other clinical trial hubs as a preferred global destination for clinical research.6 CRM, therefore, is also equipped to manage the financial aspects of clinical trials and is currently used extensively by principal investigators, investigators, contract research organisations (CRO) and sponsors conducting clinical trials in Ministry of Health facilities.
CRM’s financial management services extend throughout the trial process, i.e. from prior to study initiation to its close. Legal services are also included during the initial process to support the management of clinical trial agreements (CTAs), parallel with negotiations and refining of the trial budget. CRM reviews and endorses the study budget for the CTA within seven working days (from the last feedback date received from the relevant party involved in the budget negotiation). CRM takes on full financial and administrative duties that include initial budget negotiation with sponsors/CROs and investigators, keeping track of the trial progress, budget and invoicing, receipt of funds from sponsors/ CROs and payments to various stakeholders involved. CRM also prepares statements of account for the principal investigators on a monthly basis to facilitate better planning of clinical trial activities.
Facilitating Initiation of Clinical Trials
Involvement of the finance team starts just prior to initiation of the clinical trial in collaboration with the legal department, principal investigators, CROs and sponsors. This is crucial, as CROs, sponsors and investigators each bring expertise required for the conduct of specific types of trials, whilst the finance team contributes with their experience working on the financial aspect of clinical trials across the board. The legal team facilitates the process by ensuring that the CTA meets local requirements. The finance team also supports CROs, sponsors and investigators when negotiating and finalising the trial budget with approval from these parties. The timeframe for this process is expedited by a dedicated team handling the details of the negotiations and preparation of the approved final budget for submission, though it is still dependent on response time from CROs, sponsors and investigators.
Financial Management During Trial Conduct
CRM’s involvement in the management of the clinical trial budget is to reduce payment time through a standardised financial process by prompt issuing of invoices and providing efficient disbursements of payments. This ensures that the financial management of clinical trials conducted by investigators at their respective clinical trial sites has a proper audit trail and is executed in an efficient and transparent manner.
Prior to the establishment of CRM, all financial transactions to and from government linked facilities were routed via established local medical societies or the clinical research arm of the Ministry of Health (Clinical Research Centre). Between 2012 and March 2015, payments to investigators had to go through a trust account under the purview of the Director of Kuala Lumpur Hospital. Due to red-tape processes, payments could take at least a month.
However, from April 2015, CRM’s role expanded to making payments out directly to investigators and study team members (specifically government-employed staff affiliated with Ministry of Health facilities) and similarly reduced the timelines to within two weeks. With the advancement of online banking facilities in Malaysia, these timelines have further reduced. In 2018, the total value of trial budget managed by CRM was RM 39.5 million, compared to 2015 which was only about RM8.3 million, translating to more than four times in the growth of the budget management.
In addition, CRM’s responsibilities encompass ensuring there are enough funds available for the smooth running of a clinical trial by keeping track of the budget and communicating with sponsors so that payments are as scheduled in the trial budget and CTA. If, for any undue reasons, receipt of funds from sponsors is delayed, CRM steps in to guarantee timely payments to vendors and study subjects, ensuring that trials are on track. All receipts and disbursements of funds are carefully tracked, and monthly statements of account are sent to the principal investigators for review. All financial processes performed by CRM are also audited by internal and external auditors, which include the National Audit Department and the Ministry of Health. During the close of a trial, CRM provides an added service of negotiating the best price for archiving trial-related documents from third-party vendors. This enables cost savings in a clinical trial budget as well as more efficient conduct during clinical trial study closure.
CRM in essence acts as an account manager with in-house expertise in clinical trial budget management. Its focus is to streamline the processes for all clinical trials conducted in Ministry of Health facilities and involving Ministry of Health staff. CRM facilitates the clinical trial process from the budget negotiation stage, receipt and disbursement of study funds and lastly, archiving services upon study closure.
Audrey Ooi (Acting Head Business of Development) and Yau Yit Huan (Head of Finance & IT) are from Clinical Research Malaysia.
1. European Medicines Agency. ICH Topic E8: General considerations for clinical trials – Step 5 (CPMP/ICH/291/95). March 1998.
2. National Pharmaceutical Regulatory Agency, Ministry of Health Malaysia. Malaysian guideline for good clinical practice. Fourth edition. 2018.
3. Chew BH. Planning and conducting clinical research: the whole process. Cureus 2019;n(2): e4n2. DOI: 10.7759/cureus.4n2.
4. Farrell B, Kenyon S, Shalmr H. Managing clinical trials. Trials 2010;11:78. Available at http://www.trialsjournal.com/content/n/1/78. Accessed October 2019.
5. Hatfield E, Dicks E, Parfrey P. Budgeting, funding and managing clinical research projects. In: P. Parfrey and B. Barrett, editors. Methods of Molecular Biology, Clinical Epidemiology, vol. 473. Totowa, New Jersey: Humana Press, 2009; 299-3n.
6. Ooi AJA, Khalid KF. Malaysia’ clinical research ecosystem. Applied Clinical Trials 2017. Available at http://www.appliedclinicaltrialsonline.com/malaysia-s-clinical-research-ecosystem. Accessed October 2019.
Source : Journal for Clinical Studies