Introduction

OncoTrial Finder & Reminder is a free of charge and non-profit search engine for clinical trials in the field of oncology and hematology developed as a collaboration between Novartis (sponsor), NordicNect (users) and Convert Group AS (IT developer). The content of OncoTrial Finder and reminder’s database is updated daily mirroring all oncology and hematology trials registered in Clinicaltrials.gov. Our aim with OncoTrial Finder & Reminder is to provide a user friendly service that enable users to find and stay up-to-date on relevant oncology trials within their own defined areas of interest.

OncoTrial Finder & Reminder is a ready to go browser accessible from workstations, tablets and smartphones. To utilize all functionalities we recommend using Google Chrome, Microsoft Edge, or an updated version of Internet Explorer. *This user guide provides screenshots in Google Chrome on a workstation, be aware that graphic user interface (GUI) on other browsers and tablets or smartphone can appear different.

So, why the name OncoTrial Finder & Reminder? We wanted a name that captures the functionalities and innovation of the search engine: 1. OncoTrial because the database is limited to contain trials within the fields of oncology and hematology. 2. Finder because it is a search engine that helps you find the relevant trials and 3. Reminder because we provide automated notifications by e-mail (sms might be activitated later) when there are new trials, or new information available related to your saved searches or trials. In this way, you can stay continuously updated on trials available within your defined fields of interest.

1. Get started

The cover page shows the welcome page of OncoTrial Finder & Reminder

Click on “Start searching” to enter search page.

a): Number of trials found by the search engine under current search criteria. When you open the page it will display the total number of trials in the database*. As you start typing in the free text box b) and/or apply filter(s) c) this number will decrease in real time as you limit the number of trials fulfilling the search criteria defined by you.

b): Free text box where you can type in whatever search string you want the search engine to find a match to in the trial texts in the database. This field will allow for some typing mistakes depending on how many letters/numbers there are in the search string. The results will continuously appear and adjust as you type. This field is typically useful when you want to find trials where you are looking for a specific mutation, medical procedure, name of investigator, title, NCT-code, acronym, part of trial title etc.

c): Filters are located in grey drop down boxes on the left hand side. These filters allow you to narrow down number of trials by selecting certain parameters. How to use the filters are explained in more detail in section 2.2.

d): Click this icon to log in to your user account (“My page”) or to register a user (free of charge).

e): When you have defined your search combining filters and/or free text, you can save your search to your “My page”. The “Save search” function requires that you have logged in to your user account beforehand.

f): The trials found by OncoTrial Finder & Reminder will appear as a list, where the title is shown in blue text, and the countries the trial runs in is shown in grey. Click on the downward pointing

*Note that the number displayed can be lower, it will self-correct as you go on with your search

arrow to the right to see the expanded information for the specific trial of interest , or click on the title of the trial to get more information (section 4.2).

g): The search page display the 20 trials found by your search criteria per page. On the bottom of the page you can go the selected page number, the next page, or the last page, by clicking the respective “number” or “>” or “>>” buttons.

Figure 1

1.1. How to create a “My Page”

In order to utilize all the functionalities OncoTrial Finder & Reminder provides we recommend that you create your own user profile. The “My page” is needed if you want to save searches and/or single trials, and if you want to receive notifications related to your searches and trials via e-mail (or sms (not yet activated). To create a “My Page” simply click on the icon and then click “Register New Customer”
Provide your e-mail address, a cell-phone number and create your personal password . When finished click “Register” to create your “My page”. Your personal data is handled under the GDPR legislation, and will not be used for other purposes than send you notifications about your saved searches.

1.2 How to edit your user profile

If you need to edit your account information, you first need to click on the “My page” icon to sign in to your account

Then provide your e-mail adress and password and click “Sign in”

In the top righ corner on your “My page” site you will find the box “Edit account information”. Click on drop-down arrow to the right and then click on “Edit account information”

Edit your new account information and press “Update” for the changes to take effect, or “Cancel”.

2. Start searching for trials

OncoTrial Finder & Reminder allows you to search for trials using a combination of predefined filters and free text. You can start using the search engine without registering a personal account, but if you want to save your searches and trials of interest and get notifications you will be asked to “register”/”sign in” to your own “my page” (see previous section). The search strategy are built on a funnel principle, where you have access to the entire database of trials, and then narrow down using filters and free text. You might experience that the search engine will return some trials that are less relevant to the criteria defined by you. This is a conscious trade off we have coded into the algorithm, where we have tuned to search engine to return some "false positives" compared to risk leaving out "false negatives". This is explained in better detail on how each filter is defined (section 2.2).

2.1 Search using "free text"

Free Text search: When you start typing into the free text field (b) fig. 2), the search engine starts to match your text-string to the database content. As you type your free text you will notice how the number of trials reduces ((a) in fig 1), the listed trials appearing also changes in real time. Only trials containing trial information matching the string you type in the free text field will show up. Note that the search engine do allow for some typos (number of allowed typos depend on the length of the search string). This option might be a source for false positives; however, the most relevant hits will always show on top of the list.

You can use the free text field to search for whatever combination of letters and numbers you want, and it is a good way to increase the precision of your search especially used in combination with predefined filters. For instance you may want to use the free text field if you are interested in trials on a specific mutation or subtype of disease, or intervention. Maybe you look for a specific trial where you have the name of an investigator or hospital, the name, acronym or NCT trial ID-number.

Typically, we recommend to use the free text to specify your search for criteria that are not already covered by the available filters (described in section 2.2). (E.g If you are interested in trials within a specific cancer type (e.g breast cancer) we recommend to select the filter “Condition Group”-> “Breast Cancer” instead of typing “breast cancer” in the free text field. You can consider refining what breast cancer type using the free text after applying the relevant filters.

2.2 Search using filters

The filters are pre-defined criteria that you can select to narrow down your search to exclude trials that are less relevant to you. While the string in the free text is matched against the entire trial information text, some filters match specific information fields. Therefore, a good way of building your search is to apply relevant filters first, and then specify using free text.

In the current version 0.0 there are 9 main categories of filters: Age, Status, Phase, Country, Condition Group, Condition, Custom Location, Intervention, and Masking. All this categories have subcategories of filters that can be selected. Filters selected from two or more different main categories will operate using an “AND”- logic, meaning that both or all filter criteria have to be fulfilled for a trial to be a result. However, certain subcategories operate under an “OR” logic, allowing you for instance to select multiple countries, where the trial has to be located in at least one of these countries to show up as a result.

Filters with subcategories using AND –logic are “Age” and “Condition Group”. Filters with subcategories using OR – logic are “Status”, “Phase”, “Country”, “Condition”, “Custom Location”, “Intervention”, and “Masking”.

To apply a filter, first click on the downward pointing arrow on the right side in the filter box to get a dropdown view of all filters in that category. Select the filter(s) by clicking the “> “ to the left of the filter. The selected filters will appear in a turquoise box (beneath the number of trials result). You can unselect each filter by clicking the red x to the left of the filter or clicking “Clear all filters” to remove all. You can add and remove filters, but notice that filters of subcategories that do not return any trials fulfilling all your combined filters

2.2.1 Age

The Age filter can be used to exclude trials that has a defined age group in the eligibility criteria. The filter has three subcategories “Elderly (>75 years)”, “Adult” (over 18), and “Child/Pediatric (<18)” (Fig.10). This filter is vulnerable to the information provided by the sponsor, so we recommend to use this with caution. This filter can be useful if your search returns too many trials, and you want to see only pediatric trials for instance.

2.2.2 Recruitment Status

The “Recruitment status” filter refers to the recruitment status of the trials and is very useful when you want to exclude trials that does not currently recruit patients. This filter is coded using the “OR” logic, this enables you to select multiple recruitment status subcategories (eg. “Recruiting”, “Active, not recruiting”, “Unknown status” and “Not yet recruiting”) to monitor trials that might be open for recruitment in the future. Be aware that trials changing Recruitment satus to a subcategory selected as a filter in a saved search on your “My page”, will trigger a notification. This enables you to keep track on new trials or existing trials changing recruitment status (eg. From “Not yet recruiting” to “Recruiting”).

2.2.3 Trial Phase

The Trial Phase filter refers to the experimental phase of a trial and has six subcategories. The Phase filter is coded with “OR”-logic, allowing you to select multiple phases. The filter is useful if you search for trials in a certain phase, but if the phase is not of importance, we recommend not to apply this filter to avoid losing trials that might be of interest.

2.2.4 Country

The Country filter contains all countries running trials within oncology and hematology. This is coded using “OR”-logic allowing you to select multiple countries. This is useful if a patient is open to travel to participate in a trial in one or more foreign country (-ies). Note that as you narrow down your search, countries that do not run any trials satisfying your criteria will not show up in this subcategory for that specific search.

2.2.5 Condition Group

The Condition Group filter is the filter where you might want to start to build your searches. This filter contains a set of pre-defined condition groups. The condition group was made to group the >20 000 different oncologic conditions appearing in clinicaltrials.gov into buckets. Each subcategory in this filter contains a curated set of synonyms or subsets, which means that when a cancer type is selected from the condition group filter OncoTrial Finder & Reminder will find all trials that match to one or more of the synonyms and subsets defined under the respective category. This filter will expectedly return numerous false positives, and therefore is a good starting point to build your search and add on other filters on top, to narraw down (eg. Condition, or free text)

2.2.6 Condition

The Condition filter enables you to filter on whatever information sponsor has entered in the “Condition” bracket when registering a trial in Clinicaltrials.gov. Since the source data in this bracket is not subject to standardization there are >20 000 different conditions in the database and we recommend to use this filter with caution, as you run the risk of losing trials as false negatives. However, if you are looking for certain subcategories of disease, you might want to try this filter.

2.2.7 Intervention

The Intervention filter enables you to filter on whatever information sponsor has entered in the “Intervention” bracket when registering a trial in Clinicaltrials.gov. Since the source data in this bracket is vulnerable to individualized semantics we recommend using this filter with caution, as you run the risk of losing trials. However, if you are looking for specific intervention types, you might want to try this filter.

2.2.8 Masking

The Masking filter is a filter that enables you to filter on the type of blinding applied in a trial. The subcategories are coded using “OR”-logic allowing you to select multiple subcategories where at least one has to be present. For some patients it might be of importance whether a trial masking is “None (open label)” or randomized. Typically, this filter is used when there is a need to exclude all trials that are not open label, if not leave this filter unchecked.

2.3 Save search to your profile

In order to save a search you first need sign in with your user account and password. If you try to save a search without being signed in you will be asked to sign in, or register account if you don’t already have one (see section 1.1 How to create a “My page”).

When you have created your search using a combination of filters and/or free text, press the green “SAVE SEARCH” button, and give your search a title -> press enter / or click “SAVE” . The search will be saved to your “My Page” and you can access all your saved searches by clicking the “My page” icon (fig. 15). The free text string and filters you used to create your search show up beneath the title of your search. To access your previously saved search(es), just click on the title.

2.4 Save a single trial to your profile

You may also save single trials of interest to your “My Page” by:

->Click on the downward pointing arrow to the right of the title of your trial of interest

-> Click the “Follow This Study” box that appears. The trial will be stored under “My Subscriptions” on your “My page

3. How to ask for notifications

In order to keep you as a user updated on your saved searches and trials, we developed the notification feature. You can ask “OncoTrial Finder & Reminder” to notify you by e-mail (sms not yet available) whenever trial information in your searches and/or saved trials changes. The notification feature is valuable if you do not want to spend time to regularly search for new trials. The way “OncoTrial Finder & Reminder” do this, is that it on a daily basis compares the content in the trial database, we the updated information provided by Clinicaltrials.gov. If there are discrepancies in the old and new content in one or more trials found in your saved searches, this information will be highlighted and a notification will be sent to users who have opted in for notifications. The changes will be visible on the “My page” regardless of whether notification is turned on or off.

3.1. How to turn notifications on and off?

Notifications can be turned on or off separately for different searches and/or trials saved to your “My Page”:

To turn notification on:

->Go to your “My Page” to see all your saved searches and trials (subscriptions)

->Check the box for “SMS” and/or “Email” to the right for each saved search or subscription to turn on notification. (Make sure that the white checkbox turns blue)

To turn notification off:

->Go to your “My Page” to see all your saved searches and trials (subscriptions)

->Click the checked boxes (blue) for “SMS” and/or “Email” to the right for each saved search or subscription to turn off notification. (Make sure that the blue checkbox turns white)

3.2. How can I see what information has changed?

All your saved searches and trials are visible on your my page, and all changes to information in trials matching these searches and subscriptions are counted and made visible as a red click-button to the right of the search-title.. The box is red as long as it contains new changes that you have not looked into by clicking the box.

To see the “changelog” click on the red box, and you will see the respective date of previous and most recent modification and a list of the information that has changed or been modified from “old value” to “new value” . In the example in figure 19, note that the recruitment status of the trial has changed from old value “suspended” to new value “recruiting”, and more detailed information added regarding recruitment status of each location. Notice how the red box turns into green box to let you know that you have looked into the new changes. You may still investigate the changes, by clicking the green “Recently Changes” box

4. Accessible trial information

OncoTrial Finder & Reminder provide multiple levels of trial information. Whenever you search for trials, the results are shown by the title in blue (sorted by relevance to your search criteria), and the locations (countries) beneath the title in grey

4.1. How to access short summary of trial

To access a short summary of the trial:

Click on the downward facing arrow placed to the right of each trial title to see the expanded information for the specific trial.

The expanded information contains the unique NCT-number, Acronym (if any), Recruitment Status, Conditions, Interventions, Gender limitation, lower Age limit, Phases, Enrollment target, Study Type, date when trial was First posted in the Clinicaltrials.gov database, date of Last update, Start date of trial, and estimated Completion date. It also provides a direct URL link to the trial in Clinicaltrials.gov.

To minimize the expanded information, press the upward facing arrow to right of the title.

4.2. How to access extended information of trial

To access more information about a trial, you can click on the trial title (in blue) from your result list. A more detailed trial information will open in a new page, and additional to the expanded information you will see the: Brief summary, Location (site information sorted by country (Click on each country to expand) (Figure 21 a), study Design, Eligibility criteria and detailed Contact information

4.3. How to access trial in Clinicaltrials.gov

Each trial can be accessed in Clinicaltrials.gov by clicking the URL link in the expanded information page, or the link under the caption “Read more about this trial”

5. Frequently asked Questions

5.1. How are my personal data being protected?

Data privacy is granted under the GDPR rules *. Your personal data will not be shared with any third party users, or be used for other purposes.

5.2. How can I be sure to find all the trials?

OncoTrial Finder & Reminder contains the information on oncology and hematology trials that are registered and available in Clinicaltrials.gov. If a trial is not registered in Clinicaltrials.gov, or not separately registered in OncoTrial Finder & Reminder database, it will not be searchable in this tool.

5.3. Why do I get hits on irrelevant trials?

The search algorithms, parameters and filters are set to allow for more false positives than false negatives. The users may experience also to obtain results that are not limited to the condition group of interest. This is explained by the broader definition of the condition group synonyms (see appendix 1 for detailed list). Since the tool is being developed to find potential trials for one or more patients, we deem it appropriate to allow for more trials than to risk missing trials.

5.4. A filter subcategory seem to have disappeared?

Filter subcategories that will not return any trials (0 results) are left invisible. Try to modify or broaden your search, by removing some filters or adjusting your free text search.

5.5. How is the Condition groups-filter defined?

The Condition Groups filter consists of categories of cancer types, where each category has a defined set of curated synonyms or search strings deemed relevant for the category. The filter is designed to capture trials that might have some relevance to the condition group.

Condition Groups:

Search strings:

Anal Cancer

anal

Anal Cancer

anus

Anal Cancer

Rectum

Anal Cancer

sphincter

Biliary Cancer

biliary

Biliary Cancer

bile

Biliary Cancer

bile duct

Biliary Cancer

cholangiocarcinoma

Biliary Cancer

BTC

Biliary Cancer

gallbladder

Bladder Cancer

bladder

Bladder Cancer

Urothelial

Bladder Cancer

Squamos

Bladder Cancer

hematuria

Bladder Cancer

Urinary

Brain Cancer

brain

Brain Cancer

Intracrainal

Brain Cancer

meningioma

Brain Cancer

astrocytoma

Brain Cancer

glioblastoma

Brain Cancer

medullablastoma

Brain Cancer

Cerebral

Brain Cancer

multiforme

Brain Cancer

oligodendroglioma

Brain Cancer

glioma

Brain Cancer

gliomas

Brain Cancer

neuroma

Brain Cancer

Infratentorial

Brain Cancer

Neurocytoma

Brain Cancer

Pinealoma

Brain Cancer

Supratentorial

Brain Cancer

choroid

Brain Cancer

brain stem

Brain Cancer

hypothalamic

Brain Cancer

meningeal

Brain Cancer

Pallister-Hall

Breast Cancer

breast

Breast Cancer

Mammary

Breast Cancer

TNBC

Breast Cancer

HER2

Breast Cancer

Luminal A

Breast Cancer

Lumina B

Breast Cancer

DCIS

Breast Cancer

LCIS

Colorectal Cancer

colorectal

Colorectal Cancer

CRC

Colorectal Cancer

Colon

Colorectal Cancer

Bowel

Colorectal Cancer

Rectum

Colorectal Cancer

intestine

Colorectal Cancer

cecum

Colorectal Cancer

rectal

Colorectal Cancer

intestinal

Colorectal Cancer

adenomatous

Colorectal Cancer

Polyposis

Colorectal Cancer

APC

Colorectal Cancer

Gardner

Colorectal Cancer

Colonic

Colorectal Cancer

Sigmoid

Colorectal Cancer

anal