Please select a clinical trial currently posted on the Clinicaltrials.gov website. This can be a trial investigating a new drug, device, or biologic in adults or children.
Students are encouraged to use the appropriate template below to develop an Informed Consent Form (ICF) for the trial you selected.
References must be listed on a final separate page.
Pages should be about 10, all included.
Expert Solution Preview
Introduction:
Clinical trials are an essential tool in developing new drugs, devices, and biologics in children and adults. As a medical professor, it is my responsibility to provide medical college students with the necessary tools and knowledge to create informed consent forms for clinical trials. In the following answer, I will provide an example of a clinical trial posted on ClinicalTrials.gov and give instructions on how to create an Informed Consent Form (ICF) for the selected trial.
Answer:
Let us choose a clinical trial investigating a new drug in adults that is currently posted on Clinicaltrials.gov, such as “A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib and Dexamethasone (B-Vd) Compared with the Combination of Placebo, Bortezomib and Dexamethasone (Placebo-Vd) in Participants with Relapsed/Refractory Multiple Myeloma (DREAMM-6).”
To create an ICF for this trial, the following template can be used:
1. Introduction
a. Purpose of the study
b. Explanation of the clinical trial
c. Volunteer participation request
2. Procedures
a. Eligibility criteria
b. Study procedures
c. Duration and frequency of visits
3. Risks and Benefits
a. Possible risks
b. Potential benefits
c. Alternative treatments information
4. Confidentiality
a. Data and Information confidentiality
b. Permitted use of information
5. Rights and Responsibilities
a. Right to withdraw
b. Study team contacts
c. Compensation
6. Conclusion
a. Consent Acknowledgment
In each section, the ICF should use clear language that is easy to understand for potential study subjects.
References must be listed as a final separate page using the correct citation format (APA, AMA, etc.)
The ICF should be approximately 10 pages in length, including all sections.
In conclusion, creating an ICF for a clinical trial is an essential part of conducting ethical research, and medical college students must learn how to create these documents correctly. The provided template and instructions can be used as an example to guide students in making informed consent forms accurately.
