In late 2018 Novartis Pharmaceuticals, together with Pear Therapeutics, announced a phase 2 clinical trial to investigate digital therapy for adults diagnosed with Schizophrenia.
The study needed to enroll 113 Adults across 9 sites in California, Florida, Michigan and New Mexico.
The study did not use Wayturn’s digital advertising services to enroll participants. However, this article will analyze the investment needed and the services that would have been delivered if they had.
Eligibility Criteria Analysis
To find eligible participants using digital advertising, all eligibility criteria need to be translated into prescreening questions and have an estimated pass rate in a given audience.
Full Eligibility Criteriashow more
Key Inclusion Criteria:
- Signed informed consent must be obtained prior to participation in the study.
- Healthy male and female subjects 18 to 65 years of age, inclusive, and in good health as determined by medical history, physical examination, and vital signs at screening
- SCID-based DSM-5 diagnosis of schizophrenia and a total PANSS score > 60
- Proficient in English at 5th grade reading level or higher, in the judgement of the investigator
- Capable of using a mobile device (compatible with PEAR-004) and using common applications, in the judgement of the investigator
Key Exclusion Criteria:
- Major change in primary antipsychotic medication in the prior 4 weeks before screening (e.g., switching to a new agent or a dose adjustment within two weeks of randomization)
- Planning to move out of the geographic area within 3 months
- Unable to use English to participate in the consent process, the interventions or assessments
- Inability to comply with study procedures, due to severe medical conditions or otherwise
- Meet DSM-5 diagnosis for a current episode of major depression, mania, or hypomania in the past month
- Meet DSM-5 diagnosis for a current moderate or severe alcohol or cannabis use disorder in the past 2 months
- Meet DSM-5 diagnosis for a current substance use disorder (other than alcohol or cannabis) in the past 2 months
- Considered high risk for suicidal behavior based on ISST-Plus score at screening, or in the judgement of the investigator
- Previously participated in a clinical study involving PEAR-004
Most criteria are included in the prescreen questionnaire below. However, some questions are better left to phone or clinic screening due to their sensitive nature, such as the one relating to suicidal thoughts . It is also not feasible to prescreen online using PANSS scores or DSM-5 diagnosis standards, so these too are left for later screening as needed. This is reflected in the pass rates.
Criteria Pass rates
Below are the prescreening questions that Wayturn would show to people interested in the study. Pass rates come from similar studies and statistics. This analysis determines the overall number of completed questionnaires needed to reach all 113 enrollments.
Some statistics come from our past experience enrolling people for clinical trials, while others rely on external studies and past research.
|How old are you? (Must answer 18-65)||99%|
|Are you clinically diagnosed with Schizophrenia? (Must say Yes)||74%|
|Are you able to use a mobile device? (Must say Yes)||99%|
|Has your medication or current dose changed in the past 4 weeks? (Must say No)||70%|
|Will you remain in the current geographic area for the next 3 months? (Must say Yes)||97%|
|Do you suffer from depression, mania or hypomania? (Must say No)||60%|
|Do you consume large amounts of alcohol or cannabis? (Must say No)||75%|
|Do you have any other substance abuse disorder? (Must say No)||90%|
|Have you previously been part of a clinical trial for PEAR-004? (must answer No)||95%|
This leads us to an overall pass rate of 19%. However, the figure becomes smaller depending on the pass rate estimates for phone and clinic screening. On average, Wayturn finds that these figures apply:
|Participant stage||Pass rate||People left|
|Completed Prescreening Questionnaire||100%||1062|
|Passed Prescreening Questionnaire||19%||202|
|Passed Phone Screening||70%||141|
|Passed Clinic Screening||80%||113|
So in total this study needs to prescreen 1062 leads to enroll 113 people.
Total Advertising Costs & Reach
We know that we need 1062 completions. So, counting backwards, this table shows roughly what level of investment is needed from Wayturn to enroll the 113 people.
Reaching 322 000 people is going to cost $12,880 based on current digital advertising costs. But it’s not enough to reach them – we need to ensure we actually get 1% of people to click the ad after seeing it. That comes down to experience, high quality promotional materials, and testing. The majority of Wayturn’s work starts here.
As part of the investment, Wayturn writes promotional materials tailored to each clinical study. All material is subject to an extensive approval process (internally and with each client) before it is sent to the relevant IRB.
Here is an advert that could run on Facebook to find adults with Schizophrenia for this clinical trial:
Promotions are also sent to Wayturn’s database of people interested in clinical research, spread through Facebook, Instagram, Google, Youtube, Spotify, Linkedin, and to other special online interest groups.
All advertisements lead to a webpage with more information. The client logo, some background information, a map of where to find the research site, lead researchers and other essentials can all be found before deciding to start the prescreening questionnaire.
Wayturn’s webpages are made to be accessed on all devices, with no disturbing design elements or any links other than to the questionnaire. Here is an example of the first thing someone would see after clicking an advert:
The prescreening questionnaire contains all the eligibility questions outlined above and is always part of Wayturn’s services. There is also an overview document with graphs and statistics on completions, passes, failures that is accessible to the client. All data is gathered through Jotform’s HIPAA compliant databases.
Phone Booking System
Phone bookings can only be made by prescreened referrals. This ensures that the client does not spend any time on people known to be ineligible.
Any calendar can be synced with this booking system to give the client control over when bookings are made. It’s very flexible and can be customized.
Wayturn’s services are priced at the cost of advertising plus 20%. So this Schizophrenia study would be $12,880 + $2,576 = $15,456. This motivates us to always do better than our estimates. Dividing each column by the total investment of $15,456 gives us this table:
|Participant stage||Pass rate||People left||Price per person|
|Completed Prescreening Questionnaire||100%||1062||$15|
|Passed Prescreening Questionnaire||19%||202||$76|
|Passed Phone Screening||70%||141||$110|
|Passed Clinic Screening||80%||113||$137|
An investment of $15,456 is needed to:
- Create a promotional material package with videos, images, texts, automatic emails, questionnaire details and website layout to send for IRB approval.
- Program an online prescreening questionnaire according to the eligibility criteria to ensure high quality referrals.
- Design a webpage containing all study details to inform visitors fully before they can fill out the questionnaire.
- Manage advertisments, send database emails and work with influencers, special interest groups and websites to get people to sign up.
- Handle the phone booking system that saves your time by allowing only prescreened referrals who meet all eligibility criteria to continue.
- Allow for sufficient advertising budget to find all enrollements needed within the recruitment time frame.
The first step to working with Wayturn is to get a free recruitment plan and cost analysis. Click here to get started.