Proactive Project Management
In a China-based diabetes clinical trial, a combination of agile project management and innovative approaches helped to exceed site enrollment rates by 40%. In this blog, experts discuss key insights learned from the experience.
- Rosina Krings, executive director, project management (Metabolic Pillar)
- King Lo, director, clinical team manager (China)
- Ekaterina Baranova, associate director, project management (Metabolic Pillar)
For many biopharmaceutical companies, COVID-19 created challenges in moving clinical trials forward, particularly when countries were in lockdown, which made patient recruitment and engagement difficult. China presented a special case; due to cultural norms, there was uncertainty as to whether certain tactics successfully deployed in other countries would work the same or be accepted in China. For a global diabetes program, which initiated in 2019 and enrolled through 2020, a sensitivity in how different strategies were leveraged made all the difference. Initiating China was essential since almost half of the 78 global sites were located there. The original assumption was that recruitment could be delayed, but a team that understood how to operate in China was able to get the trial started and manage several situations along the way. Below we talk about strategies and mitigation plans that made this trial successful.
Adapting to Deliver on a Challenging Type 2 Diabetes Study
In the early days of COVID-19, sites for this study had been activated in other countries but not in China. Standard study set-up preparations were in place, but travel restrictions prevented activating sites on schedule. Applying innovative practices to the site activation and recruitment processes provided us with many opportunities for key insights that helped ensure successful trial delivery in China.
Understanding the Culture
Successful patient recruitment and trial management take into account that countries and regions have unique cultures. The team in China fully understood some key cultural nuances and reacted with agility in deploying solutions. Their insights include:
- Trust is critical: China’s participation in international clinical trials is still relatively uncommon. In 2019, approximately 8% of all studies registered in China were global/multi-regional versus domestic (92%).1 Building trust and establishing credibility allow for close interaction on a local front, which are necessities.
- Local national coordinators and principal investigators lend credibility: In addition to including all team members in the process, it’s very important to include the national coordinators for China and key principal investigators in meetings. Giving known, trusted individuals a speaking platform at, for instance, the virtual investigator meeting, added credibility and an opportunity for real-time interaction.
- Frequent communication is a connecting force: Site teams in China have several members and are large teams. Site staffs are larger than others across the globe and include good clinical practice (GCP) and ethics committee (EC) offices. Large teams require extensive training and clear, frequent communication. Building and nurturing relationships with site staff can be a connecting force and facilitate communication between the site and the EC. During this diabetes trial, local team were vital to passing information from the GCP office to the EC office.
- Familiarity with local regulations is a must: Regulations in China are complex and evolving. Training staff members in China submissions ensures the ability to keep up with changes and build important relationships.
- Responsiveness is expected by all: Accurate, responsive communication and goal setting are built into the Chinese culture. If a principal investigator or site in China commits to enrolling 10 patients per month, that’s exactly what they’ll do. It’s just as important that everyone on the team behaves in the same manner.
Combining Innovative Approaches with Cultural Nuances
Necessity is often the impetus to try something new. For some regions, immediate moves to virtual investigator meetings, remote monitoring, home health care, digital solutions, telemedicine and direct-to-patient shipment of investigational products (IP) (among other things) were adopted swiftly. In some more drastic situations, entire trials were decentralized. For this trial, swift action by the operations team identified what strategies would best match with cultural norms in China and achieved results. Below was their approach.
- Virtual investigator meetings to quickly activate sites: While other countries had used virtual investigator meetings to launch studies, the use of virtual investigator meetings was not standard practice in China. With so many sites to train and activate, a situation only exacerbated by travel restrictions, a virtual approach was the right answer. Success on this front was boosted by three key China-specific modifications:
- Choice of a platform with specific capabilities for interactive meetings.
- Enlisting the help of the China national coordinator and China global principal investigator to aide in knowledge transfer.
- Use of a simultaneous translator for all speakers, with coaching on pace.
- Novel approaches to get IP to patients: Direct-to-patient (DTP) drug supply was successfully used to not interrupt study treatments and to maintain integrity of the data. DTP services were set up with a shipping vendor, ensuring timely delivery of the study drugs to patients’ homes. The study continued seamlessly even when travel restrictions prevented patients from getting to sites for study visits.
In early 2020, successful execution of this trial in China relied upon our strong foundation and understanding of cultural norms in the country and this study team’s agility in adapting to the situation.
Applying proactive project management, cultural understanding, appropriate use of technology and strong relationships in the country led not only to sites getting activated at the earliest opportunity but also to exceeding site enrollment rates by 40%. Importantly, approaches like shifting from face-to-face meetings to virtual investigator meetings are now an accepted approach to advance clinical research for diabetes and other therapeutic areas. These are also key insights we can implement for other global studies involving China as a participating country.