In partnership with Trilogy Writing & Consulting
Regulatory
How well-written clinical study protocols get drugs to patients faster
In the world of drug development and approval, time is of the essence. But beginning the process with a poorly written protocol will only impede teams before a study has even begun. Julia Forjanic Klapproth, co-founder of Trilogy Writing & Consulting, describes how a well-written protocol will help patients receive their treatments sooner rather than later.
P
eople have been trying to find ways to make the processes applied in clinical development more efficient for decades. This has typically looked at finding ways to ship material faster and more reliably; better identifying participants for clinical studies; or cleaning and processing data more quickly. There are also many technical areas that can be improved on, and each of these can help speed things up. Every day makes a difference for someone suffering, and by identifying and eliminating the inefficiencies in the system, it is possible to shave time off the drug development cycle. Yet, poorly written clinical study protocols sit as a root problem in clinical development, and little is being done to improve these. The protocol is the foundation of every clinical study. It informs investigators and study staff about the study’s intention and provides a recipe for what needs to be done and how. It ensures the clinical team at the sponsor and vendors are aligned on what the study purpose is and how the results will be analysed. Finally, it feeds into the clinical study reports and, ultimately, the clinical summaries for submission dossiers.
Poorly written protocols lead to inconsistencies in the collected data as a result of differences in the timing of collection, the methodology of collection or even the state of the participants during collection. If the objectives are not clear, incorrect statistical methodology might be applied, resulting in meaningless outcomes. Clinical studies have an ethical obligation to ensure they are contributing meaningful and relevant information; poorly run studies that produce meaningless outcomes are incompatible with a patient-centric approach to clinical research.
Fix it before it’s broken
A poorly written protocol can impede teams in multiple domains, from setting up and running the study to reporting on the study and applying for marketing approval. The combined knowledge gained from all the studies of a clinical development programme provides the necessary knowledge to determine the risk-benefit profile of a new drug product. If the data collected in those studies is inconsistent, has gaps or quality issues, then more studies will be needed to eliminate those problems.
In other words, having a clinical study protocol that communicates clearly and helps users find the exact information needed to make a decision or perform their task in a consistent way would kill many birds with one stone. It has the potential to effect transformative change by improving multiple, interdependent activities. It might not be a full panacea, but it certainly takes us in that direction. The question is, why is this so difficult to achieve?
Clinical Trials Insight /
www.worldpharmaceuticals.net
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PopTika/AdobeStock
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