Radiopharmaceuticals – A recipe for success
Written by Sue Batchelor, Director, Clinical Operations and Delivery
Radiopharmaceutical (RP) studies are not your average clinical trial. For me, running these trials feels very similar to developing highly sophisticated recipes. If you like your trial meaty, with complex deep flavours and a sprinkling of chilli, you’ve found your ideal dish!
With the RP space expanding, Sponsors are looking for teams with the experience it takes to turn their synopsis into a fully rounded protocol with the maximum chance of success. Each element of RP research requires detailed consideration, planning and management. Isotope selection (lutecium, radio copper, etc), compounding method (central, local or homebrew) and administration routes are a few examples of these elements.
I feel very lucky to lead a team that can bring all elements together, ensuring the research and medical considerations match the capabilities and local processes at site, using our Nuclear Medicine departmental experience. Like Mise en Place, we dedicate the time it takes to plan and set up the study.
Over the past 10 years of working in RP, Cmed has built a package of processes that can be utilised for these very specific studies. Some examples include:
- A very specific and detailed site feasibility process ensuring all departments are consulted and the process flow of IMP, patients, assessments and samples is well understood at each site
- Early engagement with vendors such as imaging, dosimetry and central labs to understand study and site requirements
- A wealth of global regulatory submission experience
- Faster data availability, capitalising on Cmed’s technology and state of the art integration functionality in our encapsia platform for example with multimedia upload functionality in eSource, eConsent eCOA and ePRO
- Utilising a logistics coordinator to track IMP (ordering, manufacture, shipping and receipt), patient visits and assessments as well as sample tracking Cmed’s Inventory App within encapsia allows trial sites to manage randomization, inventory management and drug dispensation in real-time using a “hyper integration” between encapsia and IxRT.
Simply put, RP trials are extremely complex and it can be a daunting task to handle all the moving parts successfully. That’s why we are passionate about getting the right team involved in each study. We only allocate teams that we know have the experience and the right personalities for the amount of plate spinning, awareness and attention to detail that this requires.
Relevant Cmed experience
Working in radiotherapeutics since 2010
Phase I-III, including first in human
Oncology and Rare diseases
Mono and combo therapy trials
USA, Europe and APAC
Study sizes up to 42 sites and 180 patients
81 site relationships and over 570 patients
Our goal is that no RP sponsor or site feels they are out of their depth or struggle as issues occur without them ever being identified as a potential risk. Cmed is realistic and honest with Sponsors from the get-go and that is one of our core values as a company. We take a lot of important lessons learned from our experiences running RP trials, with which we hope to be able to continue to support RP development on a global scale.
Sue will participate in EANM’20 Annual Congress, the most valuable Nuclear Medicine Meeting worldwide, on 22-30 October.