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introduction
title
Improve Ease of Access of Clinical Studies Website
short description
Today's technology has made it simple to accomplish everyday tasks. These same advances can be applied to Clinical Trial recruiting.
Eligibility
Barriers
From a quick internet search I found the following sites where a patient could register for a clinical study: http://clinicalstudies.info.nih.gov/, https://clinicaltrials.gov/ct2/home, http://www.centerwatch.com/. From what I gather most of the sites allow studies to register and post their details. These sites are similar to a classifieds style posting, where emails/phone of the study organizers are listed.

For a participant to register in the study, they must contact an email address or call the study facilitators directly to exchange information. It’s unspecified what type of information they must provide initially, so it’s bound to take a series of back and forth exchanges before the participant agrees to enter into the study and the study agrees to register the participant. Participants are able to contact studies based upon their review of the studies after locating via search, but the study facilitators have no means of contacting potential participants who are searching on the website, even if they have already provided information to another similar study.

In the current status quo, all of the effort is on the participant to locate the study, provide their information, and finally register in a study. With the small number of current participants, along with the high number of cancer patients who are unaware they can participate in clinical trials, it would be ideal if it was as simple as possible for participants to register in studies and have the study facilitators be able to perform most of the analysis of the potential patents to determine which are a good fit for their study.

People in general are increasingly accustomed to attaining products and services with the click of a button on their mobile device or computer. Amazon has reduced ordering a product to clicking a physical button in their home, which triggers an order with the Amazon Dash platform. Uber has reduced arranging a private car or taxi like service to opening an app and clicking a button to order a car. In both of these examples, no back and forth communication is required, the service or product is simply delivered at request with minimal effort by the consumer. This is the type of convenience people are used to today. If there is too much work required on the patients’ side, there is less of a chance they will register in a study.
Provide link to a source describing the barrier
http://clinicalstudies.info.nih.gov/
Provide link to a source describing the barrier
https://clinicaltrials.gov/ct2/home
Provide link to a source describing the barrier
http://www.centerwatch.com/
What is your proposed solution to addressing the barriers?
Proposed_Solution_Kevin.docx
What are potential obstacles to your solution? How will you work around these roadblocks?
As mentioned earlier, a potential road block will be trust in the website. There needs to be a high level of trust when medical information is stored directly on the servers. Users will also need to be aware when clinical study facilitators search the patient database for potential participants, patient name and contact details are hidden from the searcher and may be only be made available when the participant agrees to partake in the study.
What % increase in accrual rates do you anticipate?
With implementation of the site, it will be easy to see how many participants are registered in studies and record this information once the website is live. As well, the collection of information regarding number of studies applied and count of users registered in studied will be easier to track. If there is a method of tracking participation rates of current studies today, it should be easy to determine the rate of increase.

After the solution is implemented, even before advertising, I would expect an immediate moderate increase due to ease of use for the patients. After advertising, there should be a more significant increase.
How do you anticipate maintaining the % increase in accrual rates over time?
As the solution is a permanent improvement, with regular advertising and promotion, the increased rates should be sustained.
How will you overcome legal/regulatory hurdles, if any?
Regulatory hurdles may include the storing of patient information and allowing parties to search this information (even with patient’s personal information masked). There will have to be disclaimers included for patients to agree to and the entire process should be transparent.

These legal hurdles shouldn’t be too hard to overcome as long as the Health Insurance Portability and Accountability Act (HIPAA) guidelines are adhered to.
Why hasn’t your proposed solution been tried before? If it has, what prevented it from succeeding?
There are some attempts to streamline the application process such as http://www.myclinicaltriallocator.com. (http://www.outsourcing-pharma.com/Clinical-Development/User-Friendly-Clinical-Trial-Website-Aims-to-Ease-Patient-Search-Process). Websites such as this have only added some basic search functionality on top of the standard clinicaltrails.gov website, by displaying search results on a map. Other than the aforementioned search capability, there is no additional functionality added.

Overall, I imagine current websites have not been already been updated because of cost or a lack of directive to update. A more holistic approach has to be taken to engage consumers and facilitate ease of use. It’s time clinical trial websites are updated to match today’s technology.

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