Assessing Interest in a Platform for Early Phase Clinical Trial RecruitmentNCT06302647
Assessing Interest in Web/App Platforms for Early Phase Clinical Trial Recruitment
An observational study of Assessing Interest in a Platform for Early Phase Clinical Trial Recruitment, run by Instituto de Investigación Hospital Universitario La Paz.
Trial summary
Study objective: To assess whether the different stakeholders (volunteers, patients, doctors and industry) involved in early phase trials would be interested in using a platform to facilitate recruitment and engagement in this type of trials. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Assessing Interest in a Platform for Early Phase Clinical Trial Recruitment
- What is being tested?
- Questionnaires
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 14 Mar 2024to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects above 18 years old willing to fulfill the questionnaire
Who may be able to join
- Participant will be over 18 years old.
- Male, female or do not want to specify.
- Participants will be capable to understand spanish language.
- Subjects able to communicate with the investigator and able to read and write and follow all study instructions.
Who cannot join
- Individuals not willing to complete the eraly phase clinical trial platform Study survey
- Individuals who do not meet eligibility criteria
Trial locations and contacts
No sites are listed yet.
Paloma Moraga contact
About this study
Official title: STUDY TO EVALUATE THE WILLINGNESS OF HEALTHY VOLUNTEERS, PATIENTS, DOCTORS AND PHARMACEUTICAL/BIOTECHNOLOGY INDUSTRY TO USE A PLATFORM (WEB OR APP) TO FACILITATE RECRUITMENT AND ENGAGEMENT IN EARLY PHASE CLINICAL TRIALS AND TO IMPROVE THE KNOWLEDGE OF BOTH HEALTHY VOLUNTEERS AND PATIENTS IN CLINCIAL TRIALS
Study objective:
To assess whether the different stakeholders (volunteers, patients, doctors and industry) involved in early phase trials would be interested in using a platform to facilitate recruitment and engagement in this type of trials. In addition, we will also evaluate the degree of awareness existing in society about clinical trials.
Study subjects: General population, patient, physicians, pharmaceutical-biotechnological industry.
Keywords: healthy volunteer, patient, pharma industry, patient associaiton, questionnaire, clinical trial, platform, recruitment, engagement.
- Being tested
- Questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Three questionnaires have been developed to be used by subjects, pharmaceutical industry or doctors in regards to the willingness to use a platform for clinical trial recruitment
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire for subjects | Questionnaire will be provided to general subjects anonymously to gain knowledge on their willigness to use a platform to look for early phase clinical trials. Receives: Other: Questionnaires | |
| Questionnaire for pharma/biotech industry | Questionnaire will be provided to Pharma/biotech industry anonymously to gain knowledge on their willigness to use a platform to promote the recruitment in early phase clinical trials. Receives: Other: Questionnaires | |
| Questionnaire for doctors | Questionnaire will be provided to Pharma/biotech industry anonymously to gain knowledge on their willigness to use a platform to have information and promote the recruitment in early phase clinical trials. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of each of the three groups that would find the platform useful
It would be deemed useful if they respond affirmatively or, in the case of a numerical scale from 1 to 5 being 1 the worse o low results and 5 the best or highest, if rate it above 4 in 80% of the questions regarding the utility of the platform.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start14 Mar 2024 (estimated)
- Primary completion15 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assessing Interest in a Platform for Early Phase Clinical Trial RecruitmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paloma Moraga, Instituto de Investigación Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302647
- Sponsor's protocol ID
- PI-6022
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STUDY TO EVALUATE THE WILLINGNESS OF HEALTHY VOLUNTEERS, PATIENTS, DOCTORS AND PHARMACEUTICAL/BIOTECHNOLOGY INDUSTRY TO USE A PLATFORM (WEB OR APP) TO FACILITATE RECRUITMENT AND ENGAGEMENT IN EARLY PHASE CLINICAL TRIALS AND TO IMPROVE THE KNOWLEDGE OF BOTH HEALTHY VOLUNTEERS AND PATIENTS IN CLINCIAL TRIALS
- ClinicalTrials.gov ID
- NCT06302647
- Acronym / sponsor ID
- PI-6022
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 14 Mar 2024 (estimated)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study objective:
To assess whether the different stakeholders (volunteers, patients, doctors and industry) involved in early phase trials would be interested in using a platform to facilitate recruitment and engagement in this type of trials. In addition, we will also evaluate the degree of awareness existing in society about clinical trials.
Study subjects: General population, patient, physicians, pharmaceutical-biotechnological industry.
Keywords: healthy volunteer, patient, pharma industry, patient associaiton, questionnaire, clinical trial, platform, recruitment, engagement.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Questionnaire for subjects | – | Other: QuestionnairesQuestionnaire will be provided to general subjects anonymously to gain knowledge on their willigness to use a platform to look for early phase clinical trials. |
| Questionnaire for pharma/biotech industry | – | Other: QuestionnairesQuestionnaire will be provided to Pharma/biotech industry anonymously to gain knowledge on their willigness to use a platform to promote the recruitment in early phase clinical trials. |
| Questionnaire for doctors | – | Other: QuestionnairesQuestionnaire will be provided to Pharma/biotech industry anonymously to gain knowledge on their willigness to use a platform to have information and promote the recruitment in early phase clinical trials. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects above 18 years old willing to fulfill the questionnaire
Key inclusion criteria (4 listed)
- Participant will be over 18 years old.
- Male, female or do not want to specify.
- Participants will be capable to understand spanish language.
- Subjects able to communicate with the investigator and able to read and write and follow all study instructions.
Key exclusion criteria (2 listed)
- Individuals not willing to complete the eraly phase clinical trial platform Study survey
- Individuals who do not meet eligibility criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesThree questionnaires have been developed to be used by subjects, pharmaceutical industry or doctors in regards to the willingness to use a platform for clinical trial recruitment | Other | Questionnaire for doctors, Questionnaire for pharma/biotech industry, Questionnaire for subjects |
Primary outcome
percentage of each of the three groups that would find the platform useful
Time frame: 3 months
It would be deemed useful if they respond affirmatively or, in the case of a numerical scale from 1 to 5 being 1 the worse o low results and 5 the best or highest, if rate it above 4 in 80% of the questions regarding the utility of the platform.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paloma Moraga contact
Questions about this trial
What is this clinical trial studying?
An observational study of Assessing Interest in a Platform for Early Phase Clinical Trial Recruitment, run by Instituto de Investigación Hospital Universitario La Paz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paloma Moraga (914975485, paloma.ucicec@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of each of the three groups that would find the platform useful (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.