Clinical Trial Questions
Are there clinical trial communities (forums, support groups, etc.)? Do patients ever interact with each other?
Are side effects ever specific to one gender or one age group? If so, is that data shared with the patient at the time they join the clinical trial?
What is the procedure before patients get the clinical trial information package? Do they receive communications from their doctor(s)?
Does every study have a placebo group and a control group?
Does Eli Lilly have “open” clinical trials (for the patient to self-actualize) or do all patients come through a doctor’s referral?
Does some kind of registration system exist for clinical trials, or is the only registration at a patient’s first check-in?
What information is shared with the study sponsor?
If data is clustered based on gender, age or ethnicity, is it possible to generate patient-specific data (particularly of the risks) and create a more tailored document for each patient?
When do patients receive their information packages? Do patients have the information prior to signing?
If the patient’s first interaction with the information package is at The Baseline, is there a medical professional present, helping explain complex wording? Are they left to their own devices in a room by themselves?
Are we allowed to change the order (and in turn, the hierarchy) of information?

General Questions
What is an ICD? What is a protocol document?
How do I enter?
How do I follow the challenge and get updates?
Who can I contact if I have questions about the Clinical Trial Visualization Redesign challenge?

Eligibility & IP
Who is eligible to enter the competition?
We are an organization. Can we enter?
Can more than one person work on a design and receive credit for it? And if the design wins a prize, how will the prize money be split among the creators?
Can my application win more than one prize?
Can I enter more than one design?
Do I retain intellectual property ownership?
What will Eli Lilly and ChallengePost do with my submission?

Submission Requirements
What do I need to use to create my design? Where can I find it?
Why do I have to release my design using the Creative Commons Attribution 3.0 Unported License?

Judging Process
What are the criteria for judging the submissions?

Public Voting
How does public voting work?
Do I need a ChallengePost account to vote?
How do I vote?
Do tweets and Facebook likes count as votes?
Can I create more than one account to vote?
Can I pay people to vote for me?
Are votes checked for eligibility before the Popular Choice Prize winner is determined?
What do I do if I think someone is cheating to get more votes?


Are there clinical trial communities (forums, support groups, etc.)? Do patients ever interact with each other?

Yes, there are clinical trial communities, but the level of interaction varies by patient. Generally speaking, most patients do seek out support communities before, during and after the study. Some communities are primarily for logistics and emotional support, while others exist to support technical or study-specific operations. During a study, patients do interact with each other, but they’re required to maintain the confidentiality of the study, as outlined in the Informed Consent document they sign.

Are side effects ever specific to one gender or one age group? If so, is that data shared with the patient at the time they join the clinical trial?

Yes, known side effects — also called adverse events — are disclosed in the Informed Consent. When side effects are specific to a particular group, they are mentioned. Generally, though, if patients fall into one of the affected groups, they are often excluded from the trial (meaning they are not allowed to enter).

What is the procedure before patients get the clinical trial information package? Do they receive communications from their doctor(s)?

This varies according to a patient’s local health system. Generally, patients consider a clinical trial when their existing standard of care doesn’t meet their needs. A local doctor generally refers a patient to specialists, who then explore advanced treatments or clinical study. Patients are provided with general trial information (i.e. “what is a clinical trial?”) as well as the specific Informed Consent for a candidate trial. They’re allowed to take this information home with them to review and consult with family and friends. Often, they’ll also seek additional information online and find patient communities of their specific disease before entering a trial.

Does every study have a placebo group and a control group?

No. Both depend on the design of the study. Placebo controlled studies are common, however in diseases with well established treatments, the control group is often considered a patient’s standard of care. There are also studies that are not Randomized Control Trials (RCTs), such as observational studies. This site provides a nice summary of clinical study types: http://www.vetmed.wsu.edu/courses-jmgay/glossclinstudy.htm

Does Eli Lilly have “open” clinical trials (for the patient to self-actualize) or do all patients come through a doctor’s referral?

Generally patients enter studies on referral from their doctor. But sometimes, such as in the case of a rare disease, patients will become very knowledgeable about their condition and will initiate the discussion with their doctor. There’s also an increasing number of “trial finder” solutions on the internet, many of which are targeted to patients.

Does some kind of registration system exist for clinical trials, or is the only registration at a patient’s first check-in?

A single “registration system” doesn’t exist. Patients work through their doctor and the investigation site, which is a term for the hospital or clinic where the study is being conducted. Investigation sites are responsible for educating patients on the study, obtaining Informed Consent and fully screening the patient to assure they match the eligibility criteria.

The sites share their enrollment status and, ultimately, the clinical study information with the sponsor so that the study results can be analyzed.

If data is clustered based on gender, age or ethnicity, is it possible to generate patient-specific data (particularly of the risks) and create a more tailored document for each patient?

Yes. Where the opportunities exist to do tailored treatment, such as with some cancers, studies can be designed to allow patients to enter specific “arms” that are tailored to them. This is more the exception than the norm at this time, but research, clinical studies and treatment regimens are clearly moving in this direction.

When do patients receive their information packages? Do patients have the information prior to signing?

Patients receive information packages from the investigational site (hospital or clinic) to consider if they want to enter the study. This information comes primarily through the Informed Consent document, which patients are encouraged to take home and review with their family, friends and others involved in the important decision of enrolling in the study. In some cases, information about the study can also be found online, such as on ClinicalTrials.gov. There are also cases in which the patient’s first interaction with the information package is at The Baseline (the first visit of the study).

If the patient’s first interaction with the information package is at The Baseline, is there a medical professional present, helping explain complex wording? Are they left to their own devices in a room by themselves?

At each investigational site there is a nurse or study coordinator available to walk through the Informed Consent and answer any questions the patient may have. Generally, patients are encouraged to take the information home with them to consult their family, friends and others.

Are we allowed to change the order (and in turn, the hierarchy) of information?

Yes. Do not feel constrained to the current layout, structure or presentation. Feel free to explore new presentations including graphical layout that will help patients better understand and engage in the study. The current frame of reference of the study representation is primarily through a scientific lens. Help us see and express study designs through a patient lens.

What is an ICD? What is a protocol document?

ICD stands for Informed Consent Document. Informed consent is a process in which researchers provide potential and enrolled participants with information about a clinical study. This information helps people decide whether they want to enroll, or continue to participate, in the study. The informed consent process is intended to protect participants and should provide enough information for a person to understand the risks of, potential benefits of, and alternatives to the study. In addition to the informed consent document, the process may involve recruitment materials, verbal instructions, question-and-answer sessions, and activities to measure participant understanding. In general, a person must sign an informed consent document before entering a study to show that he or she was given information on risks, potential benefits, and alternatives and understands it. Signing the document and providing consent is not a contract. Participants may withdraw from a study at any time, even if the study is not over.

A clinical study is conducted according to a research plan known as the protocol. The protocol is designed to answer specific research questions as well as safeguard the health of participants. It contains the following information:

  • The reason for conducting the study
  • Who may participate in the study (the eligibility criteria)
  • The number of participants needed
  • The schedule of tests, procedures, or drugs and their dosages
  • The length of the study
  • What information will be gathered about the participants

To learn more about where clinical trial protocols and ICDs come from, check out this post by the Lilly Clinical Open Innovation Team.

How do I enter?

  • Click “Register” to sign up for important challenge updates.
  • Review the Resources page to get access to the Required Sections and Fields document and the required content.
  • Create your design (Acceptable formats: PNG, JPG, GIF – non-animated, TIFF, PSD, AI, PDF, or HTML.)
  • Confirm you have read and agree to the Official Rules and are releasing your design to the public under the Creative Commons Attribution 3.0 Unported License, then submit your design by completing the submission form.

How do I follow the challenge and get updates?

When you register for the challenge, you’ll automatically be signed up to receive updates regarding the challenge. To be notified when voting begins and the winners are announced, click the “Notify Me” link. Follow us on Twitter at @ChallengePost or join the conversation with #ctdesign

Who can I contact if I have questions about the Clinical Trial Visualization Redesign challenge?

If you have questions, you can post on the discussion board or email Support@ChallengePost.com: Support@ChallengePost.com.

Who is eligible to enter the competition?

The challenge is open to individuals, and teams of individuals, who have reached the age of majority in their jurisdiction of residence at the time of entry. The challenge is also open to legally registered corporations or organizations that employ fewer than 50 people at the time of entry. (See the next question for large organization eligibility.)

We are an organization. Can we enter?

Organizations with 50 or fewer employees may enter and compete for cash prizes. Organizations with more than 50 employees may enter and compete only for the Large Organization Recognition Award, which has no cash prize.

Can more than one person work on a design and receive credit for it? And if the design wins a prize, how will the prize money be split among the creators?

Yes, teams are encouraged. If a team of individuals or an organization is selected as an award winner, the full prize amount will be sent to the submitter. It will be up to the winning team or organization to reallocate the prize money between the team members, as they deem appropriate.

Can my application win more than one prize?

Yes. All submissions entered by eligible individuals, teams of individuals, and organizations with 50 or fewer employees can compete for the Best Overall App Awards/Honorable Mention Awards, and the Popular Choice award.

Can I enter more than one design?

Yes. There is no limit to how many submissions an eligible person, team or organization may enter. An individual may also participate on behalf of more than one team, corporation, or nonprofit organization. However, if you submit two or more applications that are identical or substantially similar, Eli Lilly and ChallengePost reserve the right to disqualify all the submissions or require you to choose one submission to enter into the competition.

Do I retain intellectual property ownership?

By submitting a design to the challenge, you do not transfer any intellectual property rights to Eli Lilly or ChallengePost. Eli Lilly and ChallengePost will have the right to feature all applications entered in the competition for promotional purposes.

However, it is a requirement of this challenge that your work be released to the public under the Creative Commons Attribution 3.0 Unported License. See the Official Rules for details.

What will Eli Lilly and ChallengePost do with my submission?

Eli Lilly and ChallengePost will have the right to publicly display your submission on the challenge website. They will also be allowed to publicize your name on the challenge website in connection with the submission and the challenge during the competition and for 36 months after its conclusion. For more information on publicity rights, please see the Official Rules.

What do I need to use to create my design? Where can I find it?

Before you begin your redesign, please take a look at the following documents.

Required Sections and Fields document. This document lists all of the required sections and fields that your design must address. Make sure you include them all!

Definitions document. This document explains the type of content that is found in each section of the Required Sections and Fields document, as well as additional fields that you might find in an Informed Consent Document or study protocol that are not required for this challenge. The required sections are marked within the document.

Sample Clinical Trial Documents. For the purpose of consistency, all submitters are required to populate their designs with content from the same study. The sample study deals with advanced non-squamous, non-small cell lung cancer.

Sample Study: A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed plus Best Supportive Care versus Best Supportive Care Immediately Following Induction Treatment with Pemetrexed + Cisplatin for Advanced Non-Squamous Non-Small Cell Lung Cancer

This sample study has already been completed. You may pull copy/content from the following resources to use in your design:

Why do I have to release my design using the Creative Commons Attribution 3.0 Unported License?

One of the goals of the Clinical Trial Visualization Redesign challenge and of the Lilly Clinical Open Innovation initiative is to help move the entire clinical trial space forward.

Because of the collaborative and open source nature of this effort, all entries are required to be submitted under a Creative Commons Attribution 3.0 Unported License. This license allows the community to use and adapt the designs while ensuring that the designer receives attribution.

What are the criteria for judging the submissions?

All submissions will be judged based on the following criteria for the Best Overall App, Honorable Mention Awards, and Large Organization Recognition Awards:

  • Visual Presentation (Includes visual appeal, and whether the hierarchy and density of information is user-friendly and digestible.)
  • Patient Usefulness (Includes whether the design highlights information valuable to patients and assists them in options for their next steps in health care.)
  • Appropriateness for Mobile or Web Application (Includes the potential to implement the design as a mobile or web app.)
  • Potential Impact on Clinical Trials (Includes the extent to which the submission may enrich the clinical trial experience for patients, caregivers, and medical institutions.)

Popular Choice awards will be determined by public voting. For full details, review the Official Rules.

How does public voting work?

Visitors to the site can vote for as many submissions as they like, but no more than once for a single submission. At the end of the public voting period, the votes will be tallied and verified to determine the Popular Choice award winner.

Do I need a ChallengePost account to vote?

Yes. Before you can vote for a submission, please sign up or log in to your ChallengePost account.

How do I vote?

Log in to your confirmed ChallengePost account, go to the submission you’d like to vote for, then click on the VOTE button to vote.

Do tweets and Facebook likes count as votes?

No, they do not.

Can I create more than one account to vote?

No, the use of multiple email addresses or any form of automated vote processes will subject all votes from the person to disqualification.

Solvers may not pay or otherwise compensate anyone or provide any other type of consideration in exchange for votes.

Are votes checked for eligibility before the Popular Choice Prize winner is determined?

We take the integrity of the competition extremely seriously, and verify all votes using a variety of methods before a Popular Choice Award winner is determined.

What do I do if I think someone is cheating to get more votes?

Send us an email at support@challengepost.com