Clinical trial planning and design is an important step to ensure the success of
Posted by thsti on April 10th, 2020
The clinical trial planning and design phase is the initial step of a clinical trials toolkit. It forms the base of a strong preparation to a clinical trial. If planning and designing is done optimally, the outcomes will be truly successful.
- Trial planning needs to be done thoroughly so that all existing requirements of the trial are identified optimally. The better the requirements are identified, scope defined, and the planning is done, the better will be the chances to get higher funds, faster approvals and permissions.
- Clinical trial planning and design need to be tuned with the patient group.
- Trials need to be designed keeping the outcome in mind and for that, it is important to take help from professional experts.
- There also needs to be a justified sample size that needs to be identified by the researchers
- Professionals will also help with the best practices of handling and analysing the data and finally presenting the same to the Data Monitoring Committee.
Clinical trial planning and design is affected by:
- The involved stakeholders and their level of commitment to the project.
- How simple the entire planning and design is.
- Involvement of experts and specialists from the relevant field.
- How well the scope of each phase is drawn up.
- The fact that the overall goal of the clinical trial is clear in mind and is not over-complicated.
Proper planning and design also involve carrying out a SWOT analysis, defining budgets and allocating resources. Overall, the end goal or the objective needs to be clear so that the trial has the maximum chances of being a success.
Clinical Trial Quality Management Plan is again an essential aspect that should not and cannot be ignored. The purpose is to ensure the quality of the trial process. Adherence to a quality management tool ensures conformity to best practises and laid-down regulations, Standard operating processes, GCP or good clinical practise, and good laboratory practices. The advantage of following the quality management plan is that the trials happen faster, quality data is assured and there are fewer data related queries and issues from concerned stakeholders.
Quality assurance helps in following a systematic and planned execution plan of the clinical trial. It also ensures that all activities associated with data generation, collection and recording are done as per the standard regulations and requirements. Clinical trial monitoring is also an essential aspect that helps in ensuring that approved protocols are being met.Also See: Clinical Trial, Trial Planning, Quality Management, Trials Toolkit, Trial, Planning, Clinical
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