Planning
Before putting pen to paper it is important to research and plan properly. Successful trials often share similar characteristics. They are:
- Conceptually simple and tailored to the patient group and the reality of the context in which they are treated (high dependency ward or a community health centre?)
- Address questions of clinical relevance where genuine uncertainties exist
- Avoid unnecessarily complex/restrictive entry criteria to ensure generalisability, where appropriate
- Avoid unnecessarily complex data requirements (resulting from a careful justification of each data point to be collected)
- Ensure the most appropriate choice of control arm (where appropriate)
- Ensure robust allocation concealment (where possible)
- Ensure robust blinding of intervention or appropriately blinded outcome assessments (where appropriate). [Clinical Trials Toolkit Trial Planning and Design]
Therefore, time invested in generating a robust, feasible protocol at the development stage can influence the success of your trial.
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SEPTRE (SPIRIT Electronic Protocol Tool and Resource) is an innovative, web-based software solution that makes it easier to create, manage, and register high-quality protocols for clinical trials.
The Global Health Network Resources Gateway links to a wealth of useful resources which will assist you with considering data management, safety reporting, ethics and community engagement.
The Practihc Trial Protocol Tool provides templates and detailed information on what should be included in each section of the Protocol under the 'What should be in a good protocol' option.
CONSISE has developed standardised research protocols for Influenza, MERS-CoV and Zika Virus (ZIKV) which have all been developed with large numbers of technical experts, including WHO and incorporate knowledge and experience learned from conducting epidemiologic studies all over the world.
ISARIC is a community of research networks and individuals collaborating to provide a platform through which global, patient‐oriented clinical studies can be developed, executed and shared. Protocols, Informed Consent Forms, Case Report Forms, Standard Operating Procedures, training materials and other research tools are available to support implementation of the research.
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The SPIRIT 2013 Statement provides evidence-based recommendations for the minimum content of a clinical trial protocol. The recommendations are outlined in a 33-item checklist; the minimum list of items is by no means exhaustive*:
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ADMINISTRATIVE INFORMATION
1. Title
2. Trial registration
3. Protocol version
4. Funding
5. Roles and responsibilities
INTRODUCTION 6. Background and rationale
7. Objectives
8. Trial design
METHODS
9. Study setting
10. Eligibility criteria
11. Interventions
12. Outcomes
13. Participant timeline
14. Sample size
15. Recruitment
16. Allocation
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17. Blinding (masking)
18. Data collection
19. Data management
20. Statistical methods
21. Data monitoring
22. Safety/harms
23. Auditing
ETHICS AND DISSEMINATION 24. Research ethics approval
25. Protocol amendments
26. Informed consent process
27. Confidentiality
28. Declaration of interests
29. Access to data
30. Ancillary and post-trial care
31. Dissemination policy
32. Informed consent materials
33. Biological specimens
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*Community engagement
Community engagement is not specified in this list but is a very important and often overlooked step. Early engagement with the community will help identify relevant local partners and inform decisions about ethical trial design in an LMIC setting.
This engagement can help inform:
- protocol development
- approaches to seeking and documenting consent
- conducting the research, e.g. employing or training community members
- reimbursing the community for additional costs or use of resources, e.g. researcher accommodation, water, power, etc. (where appropriate)
- access to data and samples resulting from the trial
- understanding how best to disseminate research findings to maximise the benefit to the community [MRC GUIDELINES FOR MANAGEMENT OF GLOBAL HEALTH TRIALS]
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For further information on community engagement consult MESH: This member site is a collaborative open-access web space for people involved in community engagement with health research in LMICs. It provides an online meeting place where community engagement practitioners, researchers, health workers and others can network, share resources and discuss good practice. Click here for a paper called 'Moving targets: The challenges of studying infectious diseases among pregnant women in resource limited settings' which highlights the importance of community engagement and here for a webinar on community engagement in clinical research. |
Lessons learned
Looking at published protocols, reading articles about trial success factors and lessons learned pieces can help you with developing your protocol. Some examples are below and others can be found on the External Resources tab.
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Example protocols:
This toolkit from the Children's Hospital of Philadelphia Research Institute has example protocols for both descriptive and observational trials.
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