10 ways to maximize your clinical trials budget 

Running a clinical trial in 2021 is tougher than ever. The average cost of developing a new drug has reached a staggering $2-3 billion ^[1] so it’s no wonder that clinical trial researchers are looking for ways to tighten up and make their budgets stretch further.

Set-up times are being increased by trends such as the growth of multi-site and multi-country trials; in a sample of 400 trials, researchers found that the average time taken for commencement was between 5-6 months^[2].

The reality is that 85% of clinical trials will experience delays and the impact on budgets can be huge. Here are 10 ways that you can maximize your budget and minimize delays.

1. Start with a Realistic Budget

Scientists, it seems, tend to underestimate the cost of clinical trials – in some cases by up to 16%^[3]. It’s impossible to plan for unforeseen occurrences that can stall your trial – but you can budget for them. In March 2020, there was around a 65% global average decrease in the enrolment of new patients year-over-year, so include a contingency large enough to accommodate any potential problems like protocol amendments, recruitment issues or difficulties managing outsourced vendors^[4]. Make sure to include known variables like inflation.

2. Be prepared to pay for CRAs

The worldwide shortage of Clinical Research Associates is increasing demand and pushing up wages^[5]. One recent investigation found 14,000 CRA roles advertised across the world. Think long term and invest time and resources in attracting the right staff and work hard to keep them. In practical terms, you may need to increase wages, but this will likely be offset by avoiding delays. According to Maria Ladd, Senior Manager, Global Study Start-Up, inVentiv Health, “The CRA/site relationship is a critical factor in the overall clinical trial process. The right CRA can keep site staff grounded and engaged, ultimately serving to meet the goals of both the CRO and the sponsor.”^[6] Being willing to invest in the right CRA can ultimately help you maximise your budget further down the line.

3. Outsource wisely

Outsourcing is a trend that shows no signs of slowing, as companies seek to cut costs by conducting trials in more cost-effective locations^[7]. The market for CRO services is buoyant, but it’s worth picking a partner wisely. Do your research and choose only those with a proven history of delivery.

4. Have effective Clinical Trials Agreements (CTAs) in place

The increase in the number of trials means there is greater competition for site locations, which can make identification and negotiation a time-consuming process. Having a solid CTA in place before you approach sites can help you to manage this process efficiently, saving precious budget^[8].

5. Better site identification

It can cost between $20 - $30,000 to initiate each site, with maintenance costs of up to $1,500 per month. Recent research has found that up to 11% of all multi-center trial sites aren’t activated^[9]. As such, senior research fellow at the Tufts Center for the Study of Drug Development, Mary Jo Lamberti, Ph.D., believes that sharing information on the most effective sites within your organization (and potentially with others) can help you to identify the most effective sites^[10].

6. Find the right equipment provider

The global clinical trials supply market is growing at almost 7% a year^[11]. The growth is positive, with new entrants increasing competition. However, in the clinical trials supplies market it's quality, not cost, that should be the determining factor. Timely delivery of supplies across all sites can help you avoid any unnecessary delays. Working with an experienced and knowledgeable partner is key - so choose wisely.

7. Invest in a clinical trial data management (CDM) system

Technologies like Clinical Data Management systems are helping researchers to manage multiple data points, improving the way they conduct trials. Increasing the use of technology like CDMs can help you to plan and budget more effectively. With the CDM market growing at a healthy 13% and forecast to reach 14.7% in 2025^[12] it seems more researchers are choosing to go digital^[13].

8. PrioritiZe patient engagement

Engaging with patients taking part in your trial isn’t considered a priority for many but investing in effective communication with participants could help to improve retention^[14]. By keeping patients on board as your trial progresses, you won’t need to continually recruit. And in doing so, you’ll save money.

9. Get social

Competition for patients to take part in trials is making researchers think outside the box – and innovating beyond traditional recruitment methods may also be cheaper and more efficient. Studies show that although doctors and nurses feel comfortable discussing clinical trials with their patients, they only refer 0.2% of patients to relevant studies^[15]. So, to maximize your recruitment budget, it’s important to find ways to speak directly to patients. Increasingly researchers are turning to social media to engage potential trial participants^[16] – but it’s worth considering paid search and online display advertising. This allows direct, precisely targeted ads served to patients or caregivers, helping extend your recruitment reach and use budget more efficiently.

10. Publish on time

Lastly, be sure to publish on time. The FDA can impose fines of up to $10,000 a day if you don’t publish your results to ClinicalTrials.gov promptly^[17]. Setting reminders of key milestones can help you avoid any expensive and embarrassing setbacks.

Maximizing your clinical trial budget is a mixture of practicality, innovation and partnerships. Solid planning and a realistic appraisal of the challenges can help you stay on top of costs, but you can’t do everything on your own. Researchers are increasingly aware that working with the right partners is key to maximizing your budget – so make sure to leverage your network and find the right partnerships to deliver results on time and on budget.

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References

1. Outsourcing-pharma.com (published September 2018). Available at: https://www.outsourcing-pharma.com/Article/2018/09/26/Clinical-trial-cost-is-a-fraction-of-the-drug-development-bill  Report at: Science Direct Accessed February 2021.
2. Lamberti, M J. et al. (2018) Assessing study start-up practices, performance, and perceptions among sponsors and contract research organizations. Accessed April 2018. Available at:  http://journals.sagepub.com/doi/abs/10.1177/2168479017751403?journalCode=dijc&
3. Schultz, H. (2018). Closing the Variance Gap: The Challenges with Clinical Trial Budget Management and Forecasting. Appliedclinicaltrialsonline.com. Available at: http://www.appliedclinicaltrialsonline.com/closing-variance-gap-challenges-clinical-trial-budget-management-and-forecasting Accessed 19 April 2018
4. Grand View Research - Clinical Trials Market Size, Share & Trends Analysis Report By Phase, published January 2021. Accessed February 2021. https://www.grandviewresearch.com/industry-analysis/global-clinical-trials-market
5. Clinicalleader.com. (2018). Clinical Monitoring Salaries Turnover Continue to Rise. Available at: https://www.clinicalleader.com/doc/clinical-monitoring-salaries-turnover-continue-to-rise-0001 Accessed 19 April 2018.
6. Clinicalleader.com. (2016). Are Delays in Clinical Trials Due to a Lack of Experienced CRAs? https://www.clinicalleader.com/doc/are-delays-in-clinical-trials-due-to-a-lack-of-experienced-cra-s-0001 Accessed 20 April 2018
7. Clinical Trials Arena, published June 2020. How Are Clinical Trials Sponsors’ Outsourcing Activities Evolving? https://www.clinicaltrialsarena.com/analysis/clinical-trial-outsourcing/  Center Watch, published January 2020. A Look at the Trends Affecting Clinical Trials in 2020. Available at: https://www.centerwatch.com/articles/24510-a-look-at-the-trends-affecting-clinical-trials-in-2020 Clinicalleader.com. (2018). Analyzing The Top Clinical Trial Outsourcing Trends Of 2017. Available at: https://www.clinicalleader.com/doc/analyzing-the-top-clinical-trial-outsourcing-trends-of-0001 Accessed 19 April 2018.
8. Clinicalleader.com. (2018). Five Essential Considerations for Efficient Clinical Trial Site Contracts and Payments. Available at: https://www.clinicalleader.com/doc/five-essential-considerations-for-efficient-clinical-trial-site-contracts-and-payments-0001 Accessed 19 April 201
9. STAT. (2018). Clinical trials take a long time to get started. Here's how to speed it up. Available at: https://www.statnews.com/2018/03/28/clinical-trials-startup-speed/ Accessed 19 April 2018.
10. Clinicaltherapeutics.com. (2018). Taking the Pulse of Strategic Outsourcing Relationships, http://www.clinicaltherapeutics.com/article/S0149-2918(14)00600-6/fulltext Accessed April 20, 2018.
11. Markets, R. (2018). Global Clinical Trial Supplies Market 2018-2022 with Almac Group, DHL, Thermo Fisher Scientific, PAREXEL International & UPS Dominating. Prnewswire.com. Available at: https://www.prnewswire.com/news-releases/global-clinical-trial-supplies-market-2018-2022-with-almac-group-dhl-thermo-fisher-scientific-parexel-international--ups-dominating-300625018.html Accessed 19 April 2018.
12. Clinical Trial Management System Market Forecasts, published January 2021: https://www.reportlinker.com/p04067049/Clinical-Trial-Management-System-Market-by-End-user-Delivery-Mode-Type-Component-Global-Forecast-to.html?utm_source=GNW Accessed February 2021. PMLive. (2018). A critical juncture for clinical data management. Available at: http://www.pmlive.com/pharma_intelligence/A_critical_juncture_for_clinical_data_management_1226204 Accessed 2018.
13. Research, T. (2018). Clinical Trial Management System Market to Generate a Revenue of US$ 3.2 Bn by 2025 - TMR. GlobeNewswire News Room. Available at: https://globenewswire.com/news-release/2018/04/18/1480627/0/en/Clinical-Trial-Management-System-Market-to-Generate-a-Revenue-of-US-3-2-Bn-by-2025-TMR.html Accessed 19 April 2018.
14. Pharmaphorum, S., trials, S., drugs, N., NIBSC-MHRA, E., NSCLC, A., drug, A., collaboration, B., recruitment, S., costs, D., monitoring?, D. and Workshops, H. (2018). Survey: patient engagement a low priority in clinical trials - Pharmaphorum. Pharmaphorum. Available at: https://pharmaphorum.com/patients/survey-patient-engagement-low-priority-clinical-trials/ Accessed 19 April 2018.
15. How to Improve Patient Recruitment in Clinical Trials: https://credevo.com/articles/2020/03/31/how-to-improve-patient-recruitment-in-clinical-trials/  Mdconnectioninc.com. (2018). What the ISCHEMIA Controversy Tells Us About Patient Recruitment in Clinical Trials. Available at: https://www.mdconnectinc.com/medical-marketing-insights/ischemia-controversy-patient-recruitment-clinical-trials Accessed 20 April 2018.
16. AJMC. (2018). How Technology, Social Media Are Changing the Way Clinical Trials Connect With Patients. Available at: http://www.ajmc.com/journals/evidence-based-oncology/2017/december-2017/how-technology-social-media-are-changing-the-way-clinical-trials-connect-with-patients Accessed 19 April 2018. Whitehall Training - Social Media: Changing the landscape of Clinical Trials. https://www.whitehalltraining.com/blog/social-media-changing-the-landscape-of-clinical-trials
17. Outsourcing-pharma.com. (2018). Transparency on trial: How to navigate FDAAA 801 final rule implementation and compliance. Available at: https://www.outsourcing-pharma.com/Article/2018/04/05/Transparency-on-trial-How-to-navigate-FDAAA-801-final-rule-implementation-and-compliance Accessed 19 April 2018. TrialScope, June 2020: https://www.trialscope.com/how-to-navigate-fdaaa-801-final-rule-implementation-and-compliance/