There is a huge number of people affected by COVID-19 here in the U.S. With so much of the population impacted, many are searching for ways to give and receive help. However, the medical jargon associated with clinical trials and serum donation can be a barrier to the public identifying resources that they can benefit from or contribute to during this public health crisis. Our goal is to make an easy to use platform for the public to quickly access these resources, as well as create a database of potential volunteers for clinical trial coordinators to access.
What it does
During a pandemic like COVID-19, clinical responses must be carried out on the time scale of days. The faster that clinical trials find eligible subjects, the faster vaccines and cures can be developed, reducing strain on the health care system and saving lives. In addition, identifying people who may have developed antibodies to SARS-CoV2 has the potential to lead to novel therapeutics. It is critical that the public be connected with relevant clinicians in a rapid and effective way.
Our website, Corona F.A.C.T., uses a simple and fast questionnaire to connect the public to one of three possible avenues for participation in combating COVID-19.
- People exhibiting COVID-19 symptoms can learn if they may qualify for any clinical trials of therapeutic interventions.
- People who have recovered from COVID-19 symptoms are directed to serum donation locations.
- Those who have never exhibited symptoms are directed to clinical trials for vaccines and to blood donation locations.
The Corona F.A.C.T. questionnaire allows people to see the ways in which they can help based on exclusion criteria for each of the three participation options. The questionnaire can be filled out by an individual themselves or for a loved one, and does not require detailed medical information.
We recognize that the COVID-19 and immune status of individuals in our country is changing daily and we can take advantage of these populations pools to find the best resources for individuals to be able to mitigate the impact of the pandemic. Corona F.A.C.T. will connect people to resources and hopefully increase the number of participants by lowering the barrier preventing people from identifying relevant resources.
Our approach offers flexibility in its design, providing it with a long-lasting impact. Questions can be added or modified easily to reflect changes in the types of clinical trials currently recruiting participants. Furthermore, our framework can easily be adapted to reflect the resources available in other countries.
How we built it
We searched through all of the clinical trials currently recruiting subjects in the U.S. We used the eligibility criteria of these clinical trials to develop a short and fast questionnaire that anyone can fill out which identifies resources they may benefit from or contribute to. The questionnaire is made available online for easy access. Participants who finish the online questionnaire will be informed of the resources they qualify for immediately upon completion. The data from participants who finish the questionnaire can be stored in a searchable database that clinicians can access to rapidly obtain candidates for their clinical trials.
Challenges we ran into
As we developed our website, we focused on creating a small set of questions that clearly and efficiently refined the options available for vaccines, serum donation, and clinical trial participation down to a subset that is relevant and accessible to the user or patient. In doing so, the largest challenges we encountered were in the humanization and organization of large and often disjointed sets of data.
Problem: Not all inclusion and exclusion criteria for COVID-19 clinical trials are known or accessible to the patient audience of our website. For example: protein / immunoglobulin levels in the blood.
Solution: These criteria can be tested before official eligibility, and should not be used as a filtration parameters. Instead, all questions will focus on user/patient focused information in order to narrow down clinical trials to those that are options, and then clinical information can be shared in both directions.
Problem: All clinical trials have slightly different language / specifics accompanying their criteria. How will we represent all of these criteria in an efficient and accurate manner while maintaining user-friendliness?
Solution: There is going to be a significant human component to the data entry for our website. In order to balance efficiency (lowest number of questions) and accuracy (largest coverage of potential outcomes), the curator(s) will need to make decisions for which criteria are available for the user/patient to answer, and which questions will eliminate each trial.
The goal of this website is to provide the information for all potentially available clinical trials / vaccines / serum donation to any COVID-19 patient or advocate that is searching for treatment options. To this goal, false positives should be tolerated and false negatives should be avoided.
The purpose of this system is not to make new information available, but rather to collect and organize it in a user-friendly manner. Questions should be user-focused (our innovation) instead of criteria-focused (clinical trials government website).
Accomplishments that we're proud of
Every member of our team contributed to the development of Corona F.A.C.T. according to their unique skill sets. We came together as a team, having not all met one another until Friday, and organized ourselves and worked diligently on a complex problem. Despite the communications difficulties associated with remote work, we were able to successfully create a product prototype that we are all proud of. We hope that we have contributed, even if only by a small amount, to the ongoing efforts to minimize the human suffering brought about by the COVID-19 pandemic. We believe that our project fills a void that exists right now and we are proud that we have built something that we believe is feasible to implement quickly with the right support.
What we learned
We have learned how difficult it is to share information generated by health professionals with the public in a clear and effective manner. Organization and accessibility of information is vital for public health, particularly during a crisis as pervasive and rapidly-evolving as the COVID-19 pandemic. In order to provide appropriate resources for all access levels, from the patient to the World Health Organization, new tools need to be innovated, implemented, and maintained by appropriately qualified individuals.
The most difficult part of the transition between the large-scale needs of an organization and small-scale individual needs is information curation and presentation. In our current age, technology has made it increasingly easy to share large quantities of data across many platforms. The scale and distribution of that data, in combination with rampant misinformation, often renders it inaccessible to the average citizen.
Our website is an information-sharing tool for the public to use in order to better serve themselves and their community members. We feel as though this tool fills an important gap in information accessibility during a critical period of world-wide public health.
What's next for COVID F.A.C.T.
Future development of the Corona F.A.C.T. tool will expand its scope to include all current clinical trials, serum donation opportunities, and vaccine trials worldwide. In order to reach our mission statement goals, we recommend that volunteer curators be appointed by region or country to enter and organize data as it is updated on the NIH clinical trial website. Curators will work together to maintain consistent language and interpretation between clinical trials and donation events, and will monitor the statistics generated from website and user feedback to continue improving and updating this tool. A prototype of the website has been created, but it will have to be modified before it is functional for users. Improvements to our working model will include: A database that keeps track of questionnaire responses and is accessible to health care professionals An option for responders to share their contact information with clinicians, who can reach out for recruitment purposes Inclusion of geographic information for matching responders to local resources that they are matched with. We also recognize a unique opportunity to provide the data collected through the website to the professionals involved in both the clinical and vaccine trials and serum donation. Anonymous user questionnaire data will provide valuable insights into qualified patient pools by location and demographic. An important next step will be making the questionnaire results available to health professionals via a searchable database.
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