Assessing Interest in Web/App Platforms for Early Phase Clinical Trial Recruitment

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Assessing Interest in a Platform for Early Phase Clinical Trial Recruitment
• Intervention / Treatment: Other: Questionnaires

• Study Type: Observational
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paloma Moraga; Phone Number: 914975485; Email: paloma.ucicec@gmail.com
• Study Contact Backup: Name: Paloma Moraga; Phone Number: 914975485

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Subjects above 18 years old willing to fulfill the questionnaire

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Individuals not willing to complete the eraly phase clinical trial platform Study survey
• Individuals who do not meet eligibility criteria

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Questionnaires; 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
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.	Other: Questionnaires; 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
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.	Other: Questionnaires; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz

Study record dates

Study Major Dates

• Study Start (Estimated): March 14, 2024
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PI-6022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No