Clinical trials require collection and management of patient Informed Consent Forms (ICF). This includes outlining parameters for which de-identified information, clinical/analytical data, and specimen collected (during and post clinical trial) would be used.
Given variations in ICF parameters approved by different country and local Institutional Review Boards’ (IRBs), this could mean managing multiple versions of a Master ICF in any given clinical trial. Furthermore, each patient ICF could have opt-in / opt-out parameters designed to address patient concerns and increase the rate of study enrollment.
Patients have the right to withdraw or amend their previously consented parameters during and after the completion of the clinical trial. Additionally, post primary and translational research may require use of specimen for indications not previously specified, and test procedures not previously defined.
Currently, there is no centralized facility or service where patients could be empowered to manage the use parameters of their consented samples and associated data. Hence, consents become a static document that do not empower patients, and limit future engagement and utility of their samples and data.
The clinical research industry can change this deficiency into an effective opportunity - the opportunity of engaging patients with these two key approaches.
The Living Document
Patients would be at the center and forefront of making decisions. This means that their ICF would be a living document that they could access at anytime, decide how they manage use of their specimen and their clinical data, and have the ability to restrict or grant use of their specimen and clinical data for other research as requested.
The Dynamic Platform
This transformation and patient engagement requires a sophisticated platform that would protect patient privacy regulations, while empowering patients taking ownership of their consents, specimen and data. Most IT systems are focused on capturing paper-based patient ICFs. More advanced systems focus on digital capture, versioning and management of each patient ICF file relative to Master and IRB specific ICF versions. However, neither paper-based nor digital systems model granular consented use parameters as dynamic and propagative annotations to downstream systems, including analytical testing labs and specimen biorepositories.
- 5AM Solutions
