Starting a clinical research trial can be complex because you must consider many factors, such as recruiting patient subjects and running the research to successful completion. As the principal investigator, you are responsible for handling most of the tasks and creating a design that can guarantee a successful trial process.
You need to consider the process from the beginning to the end before embarking on the clinical research. In addition, it’s also essential to factor in the resources available, including funds and technology, to determine the scope of the study. With that said, here are five tips for starting a clinical research trial:
Create A Budget
The most crucial factor to consider before starting a clinical research trial is a budget for the entire process. The budget is critical in ensuring you have all the resources necessary for the entirety of the trial. Ensure you capture the cost of all aspects during the study to ensure you have enough funds and resources midway through the process.
In addition, you’ll need the budget when approaching potential sponsors for the clinical research trial. You can also involve the sponsors when creating the budget to get their opinion on the reasonable cost of things needed for the research trial. The sponsors will conduct their due diligence to ensure that the relevant regulatory authorities have approved the drug or device that will be the research subject. This ascertains transparency and accountability.
Review All Necessary Details
You must go into the research process with set research goals. Ensure that your hypotheses and research question are clear. Likewise, your research methodologies and design should be thoroughly explained. This makes it easy to evaluate whether it’s up to the CDISC standards and other regulatory requirements.
In addition, ensure that you show that the research has listed its full scope and limitations. This is especially relevant when conducting in-vivo studies as it may be subject to an ethics review.
As a researcher, you must prove to regulatory boards that your study will be conducted safely. Thus, your research plan and protocol must have all the relevant information, especially if you have multiple clinical trial phases.
Choose An In-House Team
Clinical research trials often take a few years to collect all pertinent data. Thus, it’s best to work with an in-house team that can lead the whole research team while the study is being conducted. In-house research associates are also essential to ensure that the trial complies with the necessary regulations.
Some clinical research trials can take a decade before they’re completed, so it’s in your best interest to hire the most credible team of researchers and scholars. Ensure that they have the credentials from their respective fields before joining your research team. Lastly, they must have a genuine interest in the research topic.
Consider Bias Control Measures
Regardless of your research team’s competence, you must still establish controls for bias. Researcher bias is common, and while this can be spotted during peer reviews, it’s still best to establish controls early on to avoid possible issues. There are multiple ways to prevent bias, some of which include the following:
- Choosing the correct sampling method for your study. Sampling methods aren’t one-size-fits-all, so you must ensure that your sampling method suits your research question and objectives.
- Have multiple people double-check the data. Since most clinical trials are qualitative, it’s best to have multiple members in your team to check the data. Consistency in interpretation can lead you closer to your research results.
- Make use of triangulation. It’s possible that you may encounter new variables through the research process that will require you to look at other theories. Doing so is crucial in protecting your study from fundamental biases.
Furthermore, you must include a conflict of interest statement in your study if anyone in your team—researchers, sponsors, conducting institutions—may have a possible conflict of interest. This is crucial to state early on, as it may be a possible area of concern to participants, and to those who will be conducting the peer review later on.
Once you’re ready and have all the resources, including a database to record the clinical trial results, you can start the research trial. Once the first few patients for the trial have been enrolled, an early audit should be conducted to ensure that the research protocol is run correctly and efficiently.
You can keep repeating this process at regular intervals. Real-time auditing can help you detect issues in the research process early on and solve them before they affect the study. This step includes ensuring that your data is stored safely without any risk of loss. You can also store data through a cloud data warehouse that will be easy for your team to access.
Before starting a research process, it’s essential to review the entire study and create a research design to help achieve the objectives. You must consider all aspects of a study, such as data storage, analysis, patient recruitment, and creating a competent team. All these factors play a crucial role in the study’s success and must be considered. Once everything is in place, it’s time to start conducting your research.