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Over the last few years, the number of clinical trials around the world has been increasing. According to Statista, as of November 24, 2022, over 434,000 clinical studies were registered globally.
The globalization of clinical trials has benefited the biopharma industry immensely — improved patient recruitment and reduced development costs. On the other hand, global trials also come with unique risks which can further spread across various geographies and time zones.
Supply chain, employee retention, patient sampling and recruitment, and cross-collaboration among various departments are some of the challenges the biopharma industries are facing in the global clinical trial management process.
Managing Global Clinical Trials: Challenges and Solutions
Patient recruitment
A primary issue that plagues many clinical trials worldwide is the patient recruitment process. For biopharma firms, it is pertinent to focus on recruitment problems and their impact on enrollments. As these issues are left unaddressed, they can carry a heavy cost on the whole clinical trial management process.
Additionally, recruiting patients from areas that require travel can add another layer of logistics. For example, patients taking a 4-6 hour journey to reach the clinic will require accommodation and travel reimbursement. Often, family members may travel with the patient and their cost needs to be factored in as well.
The dropout rate of clinical trials has historically been around 30-40 percent. It is important for firms to understand the reason behind the dropout and increase patient retention to ensure successful clinical findings. Creating patient maps and leveraging two-way smart technologies are great ways to improve retention. Decreasing excessive travel and meeting the needs of the patients is also important to ensure tje successful completion of a trial.
Funding
The cost of a global clinical trial can be excessive given the risks and the multiple factors involved. Often firms may utilize funding vertically i.e. within the organization through existing funds. Alternatively, some firms may outsource work to third parties to reduce costs.
Securing funding in itself is a challenge as there are more firms seeking funds and fewer companies granting funds. Applying for government, private agency, or foundation grants can be one way to fund your clinical trials. Targeting niche investors is also important to secure funding.
Post-pandemic hurdles
The pandemic has posed various challenges for global clinical trials. The global regulatory bodies are now adopting decentralized trials to minimize the damage.
FDA has created the Digital Health Center of Excellence for digital stakeholders to connect and build partnerships, share knowledge, and innovate regulatory approaches.
Biopharma firms can utilize decentralized trials and adopt digital health innovation practices to create consistent and efficient trials.
Managing global clinical trials is not easy. It requires a highly efficient team of A1 players to propel a global clinical trial in the right direction. Placement firms can connect you with the top 5% of talent in clinical trial development and management.
