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.

Clinical trials are the gold standard for getting new drugs and products on the market, but this lengthy process can often leave many unanswered questions, or in some cases, even spark new ideas. For instance, could there be other therapeutic applications of the drug or ways to improve its efficacy and safety? How does the drug compare with another product from a different company in terms of efficacy, safety, and cost-effectiveness? In these situations, an Investigator-Initiated Trial, also known as an IIT, can help shed light on these questions and possibly even lead to exciting new information, discoveries and innovations.

After many months of completing experiments and analysis, it is time to prepare your research article for submission and to select a journal. Journal choice is an important decision to make. Selecting the wrong journal can mean publishing delays or poor readership of your research. In this article, we provide tips on how the make the right journal choice.

Like presenting a conference paper, presenting a conference poster is a great way to showcase your research. Preparing an effective conference poster can attract attention and lead to meaningful interactions with other conference goers. However, if your conference poster is prepared poorly, you may be left standing awkwardly next to your poster while no one stops to read it. In this article, we outline how to create an effective conference poster. 

Presenting research at a conference is a major highlight of any academic’s career. Choosing the right conference is important. Not only is attending expensive (travel costs, conference fees, lodging costs), but it is also a large time investment. The conference may span 3-7 days itself, but also preparing abstracts and the presentation takes a significant amount of time.

Predatory journal is a term, coined by Jeffrey Beall, to describe publishers who are more concerned with profit than ethics. These journals are scams. They prey on unsuspecting researchers, often targeting third tier economic areas, and masquerade as legitimate publishers.

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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.