Rethinking pediatric clinical trials: guidelines from pediatric experts
In this last episode on pediatric clinical trial challenges, Begoña Nafria, pediatrician and patient engagement
Addressing the specific complexities of oncology eCOA clinical trials
The oncology research pathway is paved with numerous challenges, and oncology clinical trials have one of the lowest success rates. Many of the challenges of clinical trials are well known, and oncology trials differ from other therapeutic areas in several aspects: their design is often more complex, the procedures are numerous, the visit schedule can be intense for both patients and sites, and the design can be subject to change as the trial progresses.
Technology can bring simplicity and smooth the flow of often hectic oncology clinical trials, but what are the specific tools and keys to conduct eCOA trials in oncology successfully? This article identifies some of the relevant solutions to tackle oncology protocol complexities.
The First Patient First Visit (FPFV) milestone is often subject to change due to the fragility of the patient population or the stringency of the inclusion/exclusion criteria. The Last Patient Last Visit (LPLV) milestone is also likely to change, eg, if the patient’s health status prevents them from continuing in the trial, or if the number of patients dropping out of the trial is higher than expected. Progression of disease or progression-free survival criteria are very often used for clinical decisions, which may lead to further extensions to the trial, modification of the end-of-trial date, or even result in changes to the trial design.
Oncology trials often need to be extended or need additional safety visits to be integrated and so can be subject to frequent protocol amendments. These amendments bring complexity in both the eCOA build and the data management activities.
To guarantee the safe implementation of protocol amendments, both the project manager and data manager must be able to adapt quickly, and it is only with experienced teams and strong processes that trial complexities and amendments can be absorbed efficiently.
To help reduce these risks:
As the industry becomes increasingly comfortable and knowledgeable about DCTs, this new model will become more mainstream. However, several challenges still remain: protocol specificities will persist whilst technical challenges and clinical staff readiness will evolve. Dealing with data privacy and security rules, for which regulatory bodies remain the ultimate guarantor, will be key. To meet these challenges while keeping patient needs in mind, clinical trial sites and industry stakeholders will need to create a more flexible environment for patient-centric clinical trials.
Learn more:
In this last episode on pediatric clinical trial challenges, Begoña Nafria, pediatrician and patient engagement
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Last update : 27 April 2022