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Reaping the benefits of improved clinical study protocols


Dr Julia Forjanic Klapproth, owner and senior partner at Trilogy Writing & Consulting, explains why substantial savings could be made if teams develop more effective study protocols.


C


linical study protocols are important cornerstones on the journey of collecting the clinical data needed to elucidate


the benefit-risk profile of medical treatments/ devices. Not only do they lay down the plan for the study at hand, they serve as a repository of knowledge for its strategic intentions and will be used for multiple down-stream activities. They are the basis for trial registration, provide guidance to those running the study, and will be used by participants, ethics committees/ institutional review boards, funders, regulators, journal editors, and systematic reviewers to appraise the study. Yet, many protocols do not fully and clearly address important study elements, which impairs understanding and implementation, often leads to protocol amendments, and reduces the efficiency of using protocols in later-stage activities (e.g., the writing of clinical study reports and clinical summaries for regulatory submissions). The importance of these documents is often not truly recognized and the impact of getting them wrong costs the industry billions and delays, or even hinders, drug development. This article looks at what should be considered to optimize the designing and writing of a good protocol.


Clinical studies frequently falter because they try to do too much, and their design and intent is poorly communicated in their study protocols. The more complex a protocol becomes, the less likely it is to perform well1


to have more amendments, longer cycle times, and poor recruitment and retention rates2,3,4


. More complex protocols tend . A recent


Tufts study that gathered data on substantial 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 a global amendment2


of the amendments in these studies were considered to be avoidable2


. Notably, almost half (45%) .


Over the past 20 years, there has been a significant increase in the complexity of study designs, resulting in lower quality clinical data and increased trial costs5


. Despite initiatives such


as the SPIRIT 2013 checklist and guidelines6 and adaptive trial design techniques intended to simplify protocol design and reduce unnecessary procedures in trials, companies continue to run unnecessarily complex studies5


. These


overly 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 to the objectives and endpoints is between US$4bn and US$6bn each year5


.


In addition, the median cost of implementing a substantial amendment has been reported to be US$141,000 for a phase-2 protocol and US$535,000 for a phase-3 protocol2


. These are


substantial costs that could be avoided if teams can be made to understand how to develop and write more effective study protocols.


What makes an effective study protocol? 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 its communication. Instead of trying to do a bit of everything, the study should concentrate on a few precise questions and the


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