Unless you love writing, drafting a manuscript for your investigator initiated trial (IIT) can be a dreadful task. Where do you even begin? What do you have to include? It’s easy to procrastinate when it comes to writing, but the faster you finish it, the faster you can wrap up your study and move on to the next idea. We find that relying on inspiration tends not to work most of the time, so we recommend following a set template to help you get the job done. In this article, we’ll describe the key sections of a manuscript, what to include, and some tips on making this process as painless as possible.

Whether you’re planning to write a publication on your investigator-initiated trial (IIT) or a review paper, the first step is to perform a literature review. At first, attempting to navigate through the vast ocean of knowledge can seem quite intimidating. Where do you even begin? What information do you need to collect? In this article, we’ll describe some of the key steps that will help you efficiently tackle this process.

Investigator-initiated trials (IIT) are often fairly complex in their methodologies. Additionally, given the large amounts of data, the results from clinical studies can be overwhelmingly difficult to understand. Therefore, it is critical that you’re able to distill your study results in a way that’s easy to understand for your audience. One of the best strategies to summarize and communicate results is through the use of tables and figures. These elements are the first things that readers look for, and it’s also likely the last thing they’ll remember about your study. In this article, we’ll discuss some guidelines that will help you produce effective tables and figures for your studies. 

After long hours of data analysis and statistical tests, you finally determine that the outcome in the treatment group was statistically better than that of the control group. But before you can jump to any conclusions, you first have to determine whether the results are clinically significant. In other words, does it really matter? In this article, we'll discuss why you should consider both statistical significance and clinical significance in your results analysis. 

Investigator initiated trials are conducted to answer a research question or hypothesis about a general population. Since it would be too expensive and time consuming to test the entire population, we can only sample a portion of the population and hope that the sample is representative. We can use descriptive statistics to describe the sample, and then use inferential statistics, which we will discuss in this article, to make predictions about the entire population.

After you’ve collected the data from an investigator initiated trial, the next step is to run a series of statistical analyses to gather meaningful insights. For most people, statistical analysis can seem daunting because they’re not sure where or how to begin. So, in this article, we’ll outline how you can get started using descriptive statistics.

In our previous article, we described the basics of creating a database using Microsoft Access to capture and safely store the data collected from investigator initiated trials (IIT). However, while Access excels in data organization and storage, you may want to use another software interface, such as Microsoft Excel, R, SAS, or SPSS for your data analysis. So as a follow-up, in this article, we’ll describe how to import and export data from Microsoft Access.

Whether you need to record data from a case report form or recruit participants for a new study, you likely have come across a database. Databases are systems to collect, organize, and manipulate large amounts of data. Being able to create and manage them is essential to ensure the success of your investigator-initiated trial (IIT).

When it comes to clinical studies, there are numerous types of software that you can use to help you create and manage your clinical database. However, many of these commercial tools that specialize in clinical data management, such as Oracle Clinical (Oracle), Clintrial (Clinsoft), or MACRO (Elsevier), may be too sophisticated and expensive for your needs. Luckily, you may already have an excellent database creation tool on your computer. If you have Office 365, or even previous versions of Microsoft Office, then you already have a database management program called Microsoft Access.  Unlike Word or Excel, however, which you likely already know how to use, Access is a tool that is often less employed. So, in this article, we’ll teach you all the basics of utilizing this powerful asset to help you build a database for your IIT.

A strong study design for an investigator initiated trial (IIT) requires a well-planned budget. After all, even the best science can’t happen without money.  Good budgeting is an art form; there are numerous factors you have to consider and balance. On the one hand, you need to ask for enough funds to cover all your projected expenses. On the other hand, you don’t want your budget to be too expensive to the point that it gets rejected.  In this article, we’ll highlight some of the key considerations for creating a study budget.

As part of an investigator initiated trial (IIT), the investigator is also the study sponsor and is responsible for monitoring the trial's progress at the site. According to the International Conference on Harmonization (ICH) guideline E6 on Good Clinical Practice (GCP), the sponsor needs to ensure that 1) the rights and well-being of the human participants are protected, 2) the study is being conducted according to the approved protocol and 3) the reported data are accurate, complete, and match that of the original source. The last component is critical to ensure that the study data can be eventually submitted for FDA approval. This is often achieved using source data verification (SDV), but what exactly is SDV?

Planning how and what data to collect in an investigator initiated trial (IIT) is one of the most challenging tasks for researchers. On the one hand, there needs to be sufficient data collected to support and test the study’s hypotheses. On the other hand, the over-collection of data results in wasted resources. The case report form (CRF), which is used to collect patient data for analysis, therefore needs to be carefully designed with great attention to details.  This article will highlight some useful tips for you to keep in mind when designing your CRF.

One of the standard documentations required for an investigator initiated trial is the informed consent form.  It is a letter to the participant that describes what the study is about, any potential risks and benefits, and the rights of the research participants. The main purpose of this form is to protect the participant from any harm. Since it is also a legal document, you can imagine that an informed consent form is very lengthy and in-depth. Fortunately, there are several templates available online that you can use as a guide. In this article, we’ll go over some of the sections that you’ll need to include.

An investigator-initiated trial (IIT) protocol for a clinical trial outlines how the study will be conducted. Depending on the sponsor, IIT protocols can vary significantly in requirements and depth, so it is always a good idea to first check with the sponsor. In fact, most sponsors will have their own specific protocol templates. In this article, we’ll outline some of the standard criteria that need to be included in most IIT protocols.

Sample size is one of the most important criteria when it comes to designing an investigator initiated trial. After all, selecting the wrong size can be disastrous for a study later on. It can be quite an intimidating process if you have not done it before but don’t worry. This article will guide you through the basics of calculating the optimal sample size for your clinical study.

Designing a study for an investigator-initiated trial (IIT) can be a daunting task. Aside from satisfying the scientific and technical fundamentals, you also have to consider other factors (which may not be obvious) that can impact your study. A proposal with a weak study design will eventually lead to wasted time, effort, and money. This article will guide you through some of the critical steps to help maximize your IIT’s chances of success.

Drafting an application for a grant or an IIT (Investigator-Initiated Trial) can take an enormous amount of time and effort, so you want to be sure that your proposal has the highest chance of being funded. While there is always an element of luck, you can beat the odds by ensuring that your IIT stand out from the rest. In this article, we’ll highlight some of the critical factors that reviewers are looking for and how you can use them to your advantage to ensure your application is a success.

Drafting a proposal for an IIT (Investigator-Initiated Trial) or a grant is a difficult task even for the most seasoned academic. Even harder is crafting an application that will be successful and approved for funding. In this article, we’ll share some of our in-depth strategies to help you write your next application and improve your chances of success.

Have you identified an unmet medical need that needs to be addressed? The next step is to generate potential ideas for clinical studies and filter the best to put forth in a proposal. Keep in mind that because funding for studies is highly limited, so good selection criteria can help save you a lot of wasted time and effort.

Whether you’re writing a grant proposal or an Investigator Initiated Trial, the first critical step is to identify the unmet scientific or medical need. Too often is this step overlooked or rushed, which makes it a lot more difficult to develop a convincing idea for a funded study.  In this post, we’ll share with you our detailed approach to identifying and evaluating an unmet need for your applications.

You’ve come across an excellent idea for a study that you think would be worthwhile to submit as an Investigator-Initiated Trial (IIT), but how and where do you begin? In this article, we’ll describe all the steps and general tips for submitting a successful ITT application.

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The Sengi team is led by Dr. Brad Hall, a vision scientist and expert medical writer. A regular peer reviewer for several medical and ophthalmology journals, Dr. Hall has authored a multitude of articles personally, is a successful grant writer, medical writer, and master of the art of simplifying data and statistical analysis. Since launching in 2015, Sengi has provided medical writing and biostatistics analysis expertise to SMBs and researchers around the world that lacked the necessary means to share their scientific breakthroughs outside of the lab. Sengi’s work has enabled these companies to put advanced technology into the hands of those who need them most.