IN PARTNERSHIP
Study protocols often confuse study objectives with the study endpoints, such that endpoints are given in place of objectives, leaving the readers unclear about the fundamental aims of the study (which then must be extrapolated by the reader, based on the endpoints indicated). Similarly, it is often difficult to find important information in protocols, such as the exact dosing regimen, details about dietary or other restrictions during the study, or the intended timing for all activities (while key activities are usually described in detail, others are often only mentioned in passing, leaving site staff to guess how these are meant to be done). Another common pitfall seen in protocols is a lack of consistency between key sections such as the study title, study objectives and the planned primary analysis. If these are not aligned, the investigators are left to assume the true intention, and it is likely that different investigators will assume different things. This is not a situation conducive to obtaining the most streamlined and consistent data.
The importance of a good medical writer An experienced medical writer increases the likelihood that the protocol will be practical and user-friendly. Their experience in writing an array of protocols means they can make useful suggestions about how to depict complicated study designs to make them more understandable. In addition, when writing a protocol, a medical writer is envisioning how the data collected will appear in the study report and can help teams to understand – and perhaps choose – which parameters are going to be the most meaningful when it comes to crystalizing the take-home messages. They will help keep the team focused on these details, flagging up places that could be simplified, details that could be removed, and inconsistencies between sections. The mistake many companies make is to assume that the content stakeholders (clinical scientists, study manager, and statisticians, for instance) are also effective communicators. Out of convenience, many protocols are often written by teams at CROs who will be responsible for running the study, generally as part of a full-service contract. This may mean the sponsor has one less contract to organise, but it does not guarantee they will have a trained medical writer in place to craft a strong protocol. While those teams may be very good at the skills needed to run a study (for
recruiting, project management and study monitoring, for instance), they are not necessarily specialised in writing documents.
Conclusion In today’s regulatory environment, many studies are too complex, with protocols that are unclear and lacking important information. By consciously designing studies that are precise, simple, practical, and clearly communicated, we can improve the consistency and quality of the data that will be obtained.
With a good writing process, more robust study protocols will be generated, which will have a direct impact on the subsequent drug development journey. And with so much at stake – not only considerable costs but also the quality of the data obtained and the efficiency of many downstream activities – companies should do everything in their power to ensure that experienced medical writers are used to help the clinical teams craft protocols that communicate effectively.
The success, timelines, and costs of a study should not be jeopardised for the convenience of including the protocol writing in a package deal with a CRO. It may not be the only way to improve the design and quality of clinical studies but having specialized medical writing companies involved in protocol writing can go a long way to improving clinical study protocols, which everyone can reap the benefits from.
References 1. Kaitin KI, editor: Optimizing Protocol Design to Improve Clinical Study Performance, Efficiency, and Cost. Tufts Center for the Study of Drug Development R&D Management Report. 2013 Apr;8(2) [RS 3313]
2. Getz K, Stergiopoulos S, Short M, et al. The Impact of Protocol Amendments on Clinical Trial Performance and Cost. Ther Innov Regul Sci. 2016;50(4):436-441.
3. Getz K. Predicting successful site performance. Applied Clinical Trials. 1 Nov 2011.
4. Getz K. Protocol Amendments: a Costly Solution. Applied Clinical Trials. 1 May 2011.
5. Getz K. Improving Protocol Design Feasibility to Drive Drug Development Economics and Performance. International Journal of Environmental Research and Public Health. 2014;11:5069-5080.
6. SPIRIT Guidance for Clinical Trial Protocols: the SPIRIT 2013 Statement. Accessed at
www.spirit-statement.org
7. Kaitin KI, editor. One in Five Procedures Generates Extraneous Clinical Trials Data. Tufts Center for the Study of Drug Development Impact Report. 2012 Nov/ Dec;14(6) [RS 3235].
H1 Virtual Events: Review and Summary Handbook | 7
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58
