Global Trials: Navigating Complex Hurdles

By Dave Bowser, Executive Vice President and General Manager, Global Clinical Development,

 

All clinical trials come with their own complexities. Sponsors must tackle an intricate web of regulatory issues, approval time frames, operational challenges, and perhaps the greatest hurdle of patient recruitment and retention. And, these challenges are heightened in global clinical trials.

Designing a Global Study? Read this.

If not thoughtfully planned and strategically managed, global clinical trials can quickly spiral out of control. Sponsors are constantly left exposed – both financially and reputationally – as they navigate thousands of patients at hundreds of sites that cross international boundaries, as well as huge amounts of data. When designing a global study, it is important for sponsors to consider the following:

1. Conduct a proper feasibility study: First things first – plan properly. While it may seem obvious, planning is surprisingly often overlooked. Studies can be quick to misidentify the key areas of a clinical program. Start with simulation modeling to help predict outcomes and determine practicality for a time frame. Also, be prepped to ask key questions about the geographic location to better inform decision making.

2. Listen to the data: If the data says the time frame is not practical, do not give in to time-to-market pressures. Take the time to evaluate it avoids creating additional costs and exacerbating challenges.

3. Include investigators and patients in trial design: When we take patients and clinicians who are working with patients face-to-face into consideration, stronger relationships are formed, and we better understand patients’ limits and needs. Develop a protocol and study that is written “for the patient, by the patient.”

4. Patient-centered recruitment and retention: It is one of the greatest struggles, yet patient recruitment and retention is the area where the study has the most control. Outside of the traditional tactics, including physician referrals and on-site chart reviews, sponsors should look into new and more engaging patient-centric strategies. Today, patients play a more active role in their healthcare, so it is important to communicate with them in ways they are accustomed to using technology.

5. Choose partners with experience in global trial development: Global studies come with sizeable challenges and resource requirements. With that being said, those designing the operations and protocol must have a deep understanding of how to choose optimal partners and locations, have a global reach, and successfully use advanced technology to support patient-centric recruitment and operations.

Global clinical trials bring exceptional benefits to the medical community, but there are snares at every turn. Therefore, global clinical trial planning must minimize risk, provide maximum margin, and remain flexible.

To read more about how you can take an uncommon approach to your global trial, read “Five Best Practices for Taming the Global Clinical Trial Beast,” by Worldwide’s Jeffrey Zucker in the Journal for Clinical Studies.