In partnership with Trilogy Writing & Consulting


Regulatory


Reap the N


ot only do they create the plan, but clinical study protocols serve as a repository of knowledge for strategic intentions and are used for multiple down-stream activities. They are the basis for trial registration, provide guidance to those running the study, and are used to appraise the study. Yet, many protocols do not fully address important study elements, which impairs understanding and implementation, often leads to amendments, and reduces the efficiency in later stage activities. The importance of these documents is often not recognised and getting them wrong costs the industry billions and delays, or even hinders, drug development. Clinical studies frequently falter because they try to do too much, and their design and intent is poorly communicated. The more complex a protocol becomes, the less likely it is to perform well. More complex protocols tend to have more amendments, longer cycle times, and poor recruitment and retention rates. A recent Tufts study on global protocol amendments found that protocols with global amendments were larger in scope and had longer patient recruitment and overall study durations, compared with those without. Notably, almost half (45%) of the amendments in these studies were considered to be avoidable.


Clinical Trials Insight / www.worldpharmaceuticals.net


benefits


Clinical study protocols are important cornerstones on the journey of collecting the clinical data needed to elucidate the benefit-risk profile of medical treatments/devices. Julia Forjanic Klapproth, co-founder of Trilogy Writing & Consulting, looks at what should be considered to optimise the designing and writing of a good protocol.


Over the past 20 years, there’s been a significant increase in the complexity of study designs, resulting in lower quality clinical data and increased trial costs. Despite initiatives such as the SPIRIT 2013 checklist and guidelines and adaptive trial design techniques, intended to simplify protocol design and reduce unnecessary procedures in trials, companies continue to run unnecessarily complex studies. These complex study designs and poorly crafted study protocols are a key reason for increased costs. It has been estimated that the cost of activities included in studies not considered essential is between $4 and $6bn each year. In addition, the median cost of implementing a substantial amendment has been reported to be $141,000 for a phase 2 protocol and $535,000 for a phase 3 protocol. These are costs that could be avoided if teams are made to understand how to develop and write more effective study protocols.


What makes a study protocol effective?


There are four factors that are crucial to make a study protocol truly fit for purpose. It needs to be precise, simple, practical, and clear in terms of the study design and communication. Instead of trying to do a bit of everything, it should concentrate on a few precise questions. Many studies collect far


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