CLINICAL TRIAL IN A

Allowing remote patients to be more involved in clinical trials

Working alongside MIT and the Tufts Medical Center as my thesis project, I designed a "clinical trial in a box" that would be sent to remote patients who either cannot come in for hospitalization or live in areas that are far away from the nearest hospital. The contents of the box would help collect the patient's physiological data in real-time in a safe and confidential manner while maximizing their safety, allowing them to participate in clinical studies.

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ABSTRACT

As remote clinical trials continue to revolutionize the old-fashioned clinical trials model and increase patient enrollment, it has become apparent that there is no regulatory framework in place to standardize their utilization. In traditional clinical studies, there is very little independent user control and, therefore, error as a designated clinician performs all physiological measurements on each subject in person. However, in remote clinical settings, there is an added component of having to collect each participant’s physiological data and other necessary information over distance. This introduces the need for a “trial in a box” or remote clinical trial kits. Both the participant and the facilities in charge of the kits play a role in how these kits need to be designed, manufactured, and handled. However, there is a clear lack in the standardization of kit design.

This project provides a framework for human-subjects researchers to establish their own remote clinical trial operations. This thesis, specifically, focuses on designing the clinical trial kits that could be used for the trials mentioned in this case while also detailing design decisions in order to standardize kit design for other remote clinical trials.

BACKGROUND

The following is the ten-step framework designed to support the establishment and operations of remote clinical trials:

Parameters and Timeline of Trial
Participant Tracking System
Device Storage and Cleaning
Instructions for Device Use
Current Device Inventory
Device Inventory Tracking System
Box Design
Box Inventory Tracking System
Box Assembly Plans
Delivery Management and Returns

Each step within the framework serves as generalized guidelines to establish remote clinical trial operations. This thesis focuses on Box Design in this framework, covering the packaging design for the clinical trial kits. Content in the remaining sections of the framework was supported by the collaborative efforts of Carly Smith, Imane Ait Mbiriq, and Ryan Lin of the Massachusetts Institute of Technology, whose work is the following:

Carly Smith: Remote Clinical Trial Operations: Patient Education for Medical and Wearable Device Use
Imane Ait Mbiriq: Remote Clinical trials Operations: Supply Chain Management and Framework Development
Ryan Lin: Framework Development for Remote Clinical Trials: Assembly Process Design

BOX DESIGN

The packaging design covers aspects of the box that contains all the components necessary for the trial. These boxes will be shipped to patients to guide them through the clinical trials.

The packaging of the box for the trials shipped to patients must consider various components: the outer appearance, the inner layout of all the contents, the box’s ease in functionality, and the material of the box itself.

First, the outer appearance of the box takes into account how it would be presented to different age demographics. For example, the box should appeal to both children and adults participating in the trial. Furthermore, since this box is being shipped to the patient, it will remain in the patient’s personal environment. Therefore, the aesthetic of the box should integrate well into their surroundings while still being able to stand out as an important item that should not be thrown away or forgotten. In addition to the consideration of the patient, the box should be branded with a logo or some form of identification to associate it with this project and organization.

The second consideration when designing the box is its inner layout of all necessary components of the trial. First and foremost, the contents of the box should be kept safe and secure within the box, especially while it is being shipped and being used by the patient. The patient should also be able to easily understand what is being presented to them as soon as they open the box. With a clean and direct layout, the patient should easily locate the item they need. The components also may change with each trial. Therefore, an additional benefit would be to design a universal box that can be easily tailored towards the specific trial and its necessary components. Lastly, some of the items of the trial need to be returned. Therefore, the patient must be able to determine which needs to be returned and how.

The box must also be easy to use, specifically open and close. While keeping all the components safe, the box presents no hassle for the patient to continue to open and close.

Lastly, the materials of the box itself must be considered. It must be durable so that it can endure shipping and handling, living in the patient’s personal environment, and being returned to the facility. The box’s design must also ultimately consider its sustainability in that it can either be reused or recycled. The material of the box will also determine its manufacturability.

Box Design Research

Before designing the box design solution for clinical remote trials, I needed to see what packaging designs already existed. Some of those that particularly stood out were the Apple product packaging, Pelican cases, other smaller at-home clinical trial boxes, PurleyWHITE DELUXE, spring-loaded glasses cases, and a Backgammon set zipper packaging (shown on the right). With each of these unique designs, I analyzed the following:

What makes this packaging unique?
Is it visually appealing?
What contents does it hold?
Is it easy to use?
What materials do they use? Is it sustainable?
Is it durable?

After answering each of those questions, I created a table of advantages and disadvantages in relation to the design of the clinical trial in a box. These tables can be found in the full thesis.

Box Contents

The contents of the box vary for each trial. The two trials this project focuses on is the niclosamide trial and the long-COVID trial.

For each of the contents shown on the right, I created a table of their description, their dimensions, and whether the item needed to be returned at the end of the trial.

Manufacturing and Return Plan

All plastic parts will be injection molded as all these parts are universal to both trials. One mold will be made for the outer casing’s lid, outer casing’s body, handle, hinge, hinge pins, and latch closure. Once molds are manufactured, all parts can be injection molded with their specific materials. Since these are universal parts, the costs of preparing the molds will be offset as more trial boxes are made. Additionally, boxes can be reused. Therefore, boxes only need to be manufactured depending on the demand and the product’s lifetime.

The foam inserts will be processed by computer controlled high speed water jet cutters. The outer dimensions as well as the cutouts will be processed this way. As with the outer casing, the foam inserts can also be reused.

For both trials, some parts must be returned. The cutouts in the foam inserts for the specific devices that need to be returned will be colored and labeled. This will allow the patient to easily determine not only which items need to be returned but how to place them back into the box. The box will come with a set of instructions for how to proceed with the trial as well as instructions on how to return the package and a return shipping label.

Defining Customer Needs

The first step in the design process is to assess the patient or customer’s needs based on the considerations mentioned in the previous section and those mentioned by the Tufts team.

The following table categorizes the customer needs in terms of the box’s design and their importance ranking:

Results

The box is designed to meet the customer needs detailed above. The table to the right describes how the proposed solution meets each of these needs.

An additional design feature considered was a handle that would be attached to the top of the outer casing’s lid. This would allow for anyone to easily carry and move the box.

Material Selection

The following is the material breakdown of each of the major parts of the box with additional detail as to their advantages:

CAD Modeling

After considering the tradeoffs of each of the existing boxes researched and detailed above as well as each trial’s contents and their dimensions, the box was modeled using Autodesk Fusion.

There will be one universal box that will have dimensions that fit all the contents of both the Niclosamide and the Long-COVID trials. Within the box will be foam inserts that will have cutouts where the specific devices will be placed. This design was mostly inspired by the Pelican case.

The larger polypropylene hard shell case makes the packaging durable to stand against most damages from external factors experienced during shipping and handling as well as while in the patient’s personal environment.
The foam inserts safely secure all components.
The cutouts in the foam make it easy for the patient to identify where devices need to be placed.
Both the outer hard shell case and the foam inserts inside can be reused for future trials.

The assembled models of the box for each trial have dimensions of 23 in x 19 in x 13 in. Shown on the right are some of the CAD images of the Niclosamide trial box.