In the backdrop of geopolitical disruptions impacting supply chains in many industries, the healthcare and pharma sectors are facing several challenges in supply chains that are impacting clinical research.
As the pharmaceutical industry is dealing with recurring supply chain disruptions, the clinical trial landscape and service provider market are also becoming increasingly difficult to navigate. Striking key partnerships with vendors and implementing digital strategies are crucial to overcoming clinical trial challenges and achieving operational success. Fostering strong partnerships, adopting more patient-centric approaches, and utilising digital tools and engagement techniques can not only improve clinical trial procedures but also reduce costs.
At the recently concluded 12th Annual Outsourcing in Clinical Trials (OCT) & Clinical Trial Supply (CTS) Nordics meeting, experts provided an in-depth exploration of trends and challenges in clinical trial operations, outsourcing, supply, engagement, management and partnerships over two days.
The OCT and CTS Nordics meeting took place during 1 and 2 October in Copenhagen, Denmark, gathering industry leaders to discuss strategies and tools to achieve success in clinical research.
Overcoming challenges with engagement strategies and digital tools
Patient retention, one of the most significant challenges in clinical trials, was an overarching theme discussed across multiple sessions in the OCT & CTS Nordics. In one of the sessions focusing on gamification, Replior CEO Christer Nilsson highlighted that there are high dropout rates (30%), which can lead to higher costs and weakened statistics in a clinical trial setting. He added that high dropout rates in turn can lead to extended timelines and missed market entry and revenue due to delays.
Joachim Lovin, decentralised clinical trial (DCT) specialist at Novo Nordisk, noted that the trial information landscape is complex and difficult to navigate. He also agreed that low engagement with clinical research is a challenge that needs to be addressed and highlighted that “trial participants often lack valuable education and easy-to-understand information about their participation in a clinical trial”.
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By GlobalDataNilsson commented that gamification can be “a strategic attempt to enhance systems, service organisations, and activities by using game design elements to motivate and engage users in non-game activities”. Gamification strategies could be used in clinical research to improve patient adherence to the protocol, minimise dropouts, and enhance both the patient experience and statistical analysis. Nilsson commented that gamification techniques hinging on self-accomplishment, empowerment, and feedback include the use of trial journey maps, progress bars, and compliance ratings while actions such as providing disease information and sending reminders and notifications alongside awards and badges, can also prove helpful.
During OCT & CTS Nordics, John Zibert, CMO of Swedish biotech Coegin Pharma, also stressed the importance of educating a patient on how to use digital elements in a clinical trial. Lovin also commented trial participants need to be correctly instructed on how to collect clinical data on the devices the trial organisers need to verify and ensure that participants are well-informed and comfortable with the DCT elements. Zibert mentioned that using e-learning via YouTube, emails, or texts to provide information on the indication, facts about treatment, and study protocol improves patient autonomy and can help reduce staff workload and guarantee patient safety in the trial.
While discussing the implementation of digital tools to enhance the patient experience, Zibert emphasised that, despite some drawbacks, the benefits of DCTs often outweigh the disadvantages. He noted that nearly 49% of participants in traditional studies drop out due to issues like transportation and daily life challenges. Since transportation is crucial, DCTs that use remote monitoring can reduce patient turnover and allow for more consistent, real-time data collection, improving study efficiency and safety. Lower patient turnover can reduce operating costs, particularly in terms of labour, which is a significant expense in clinical trials.
According to Lovin, DCT elements should be fit-for-purpose, driven by the unique needs of the clinical trial and its participants. Additionally, Zibert highlighted that a CRO’s responsibilities include technology support and evaluation, and online outreach while principal investigators should be involved in pre-screening and oversight from the beginning.
Requirements to forge successful and long-term CDMO partnerships
Another topic addressed during the annual OCT & CTS Nordics meeting was that of clinical trial material manufacturing. Sebastian Bauer, CMC director of CombiGene, described the landscape for contract development and manufacturing organisations (CDMOs) through the eyes of a small biotech company. During his presentation, he characterised the current adeno-associated virus (AAV) vector manufacturing landscape in 2024 as a “buyer’s market” – with companies competing for clinical trial material manufacturing.
Bauer noted that innovation in CDMO processes happens gradually due to high costs and limitations, making it challenging for small biotech companies to explore new approaches. However, he highlighted a potential shift from plasmid DNA (pDNA) to synthetic DNA as a possible innovation strategy in AAV manufacturing, which can offer significant cost savings and improve sustainability.
Bauer emphasised that small biotech companies must consider the future licensing potential of their products when selecting a CDMO partner for clinical trial material manufacturing. He suggested that the ideal request for proposal (RfP) process for a long-term partnership should be divided into three stages: a feasibility study, clinical trial material manufacturing, and commercial production.
Additionally, biotechs should assess the CDMO’s experience with specific AAV serotypes and the suitability of their AAV platforms, with feasibility studies confirming their effectiveness. Bauer noted that for therapies requiring small drug quantities per patient, the focus should be on quality and safety during development. However, when considering out-licensing and larger-scale commercial needs such as treating chronic conditions with millions of patients, early planning for production volume is critical when choosing a CDMO partner.
