Starting a new trial
Before starting a new trial, consider the research question and formulate detailed objectives. Determine which type of clinical research your project is. There are essentially three types of studies: analysis of existing data or specimens, observational studies and interventional studies. Study preparation process differs according to the study type. If you are considering an interventional study, then this toolkit is for you.
Once you have your research question, take time to think about your trial and its setting. Planning for the trial should be largely completed, before any field activities have taken place (other than initial feasibility studies and small-scale pilot investigations). Detailed planning is necessary for several purposes:
- Information on the trial will be required by local and national administrations as part of the trial approval process, as well as by any agency that is going to review the proposal for funding.
- Possible problems must be anticipated in advance and solutions thought through, in order to reduce the likelihood of the trial falling behind schedule or having to be radically changed or abandoned, due to problems that could have been foreseen and avoided.
- Realistic estimates must be made of the resources needed and the likely trial duration, including the time to analyse and report the trial, in order to be able to calculate the required budget for the trial.
- The expertise of your trial team and organization should be considered and you should strongly consider inviting additional experienced inviduals to collaborate if your team is lacking in experience in some areas.
- Patient and Public Involvement should be considered as this may modify your trial methodology or objective in useful ways.
The ISN Trials Toolkit aims to help you along every step of the trials journey, from protocol development through funding requirements, registration, sourcing the Investigational Medicinal Product, contractual agreements, ethical/regulatory approvals, training study staff, preparing for data collection and analysis of results, to their publication, dissemination, and potential use in disease control. Finally, don’t forget to consider what might come next and anticipate the form of any studies that will follow, depending on the possible different outcomes of the trial.