The Impact of eConsent: Electronic Consent Clinical Trials on Retention Rates

For a long period of time the retention of participants across all clinical studies has been problematic, eobviously this translates to a lot of money being wasted on the clinical trials. This is where Electronic consent clinical trials play a crucial role as they automate the entire recruitment and retaining processes. Firstly, having a participant consent electronically instead of using paper eliminates an unnecessary cost and most importantly pushes for better understanding.

Sildent e-consent applications can increase randomization rates by about 22%, reduce and hopefully eliminate patient dropouts, and provide a more natural and wider exposure based consent that enables the patients to fully appreciate the advantages as well as the risks attached to being a part of the clinical trial. Due to a discontinuity of attendance during said therapy, a patient may be lost even if they have previously expressed a predilection for the therapy, and have duly given their consent.

What is eConsent?

eConsent implies the use of electronic technology with the objective of obtaining informed consent from participants in any clinical trial. eConsent enhances comprehension of trial protocols, risks and benefits through audiovideo, clear graphics and simplified written explanations of the provisions.

How eConsent Boosts Retention Rates

Clinics today have begun to adopt tech-centric methods by introducing Electronic Consent (eConsent). This form of consent is accessible which means that it has a global reach and improves clinic drop out rates. Overall, understanding and cooperating through eConsent definitely benefits the participant as well as the clinical trial itself.

Key Ways eConsent Boosts Retention Rates

1.Improved Participants’ Perception

Participants have better comprehension about the needs of the study hence losing track and possibly dropping out is minimized. In a survey of 2013, it was established that 35% of participants who withdrew from a study did not have an understanding of the consent forms while only 16% of those who continued with the studies fell under the same category. eConsent offers diagrams, videos and interactive content to assist participants in understanding the material better.

2.Comfort and Flexibility

eConsent enables participants to sign and review documents remotely therefore resolving geographical barriers. This is particularly useful for the elderly, individuals with chronic illnesses and those in under populated regions as there is enhanced participation in the study. The platform permits participants to come in from the comfort of their own devices hence less traveling is required.

3.Clarity

Digital consent platforms simplify the documents on what is expected of the participants and what risks are involved in the study. Participants are kept in the loop with what’s happening in the trial through frequent sentences and notifications. Participant’s progress is constantly monitored enabling the site to identify concerns early and Rectify them immediately.

4.Individualized Experience

eConsent ensures that the participants are involved as they are allowed to go through the material at their own pace. Adjustable font sizes, having multi-language formats and audio recordings allow participants from diverse backgrounds to engage. This feature allows participants to clarify any doubts immediately through video calls making interactions more personal.

5.Facilitated Re-consent Mechanisms

The system notifies the participants automatically about what consent forms or documents to submit whenever applicable, which means that participants always have the latest IRB approved brochure in their possession. The digital system maintains up to date status of consent, stamps the relevant documents and cuts down on the workload. Such automation also facilitates compliance with the rules and regulations regarding the obtaining of consent and reduces the risk of any consent related deviations from the protocol.

In fact, it has been demonstrated in studies that eConsent improves randomization rates by 22% and might reduce patient dropout rates by 4-6%, which is a vastly positive change in the efficiency of clinical trials and retention of participants.

Challenges and Solutions

Electronic consent (eConsent) presents both challenges and innovative solutions for improving patient retention in clinical trials.

Challenges of eConsent

• Limited in-person discussion with research staff
• Potential confidentiality concerns about accessing consent documentation2
• High initial infrastructure and technology expenses
• Potential barriers in patient comprehension

Impact on Retention Rates

Clinical trials face significant retention challenges, with approximately 30% of patients dropping out, resulting in substantial financial costs. eConsent addresses these challenges by:

• Increasing patient understanding through multimedia resources
• Providing contextual assistance and accessibility features
• Enabling patients to consent from home
• Offering clearer communication about trial participation

Key Retention Improvements

• 22% increase in randomization rates
• Potential to retain 4-6% more participants through improved consent processes
• 35% of dropouts related to difficult-to-understand consent documents

Solutions to eConsent Challenges

• Implementing comprehension "quizzes" to verify patient understanding
• Using secure video calls or phone consultations
• Establishing dedicated study coordinators as patient contact points
• Offering incentives like travel reimbursements and meal vouchers

By addressing these challenges, eConsent can significantly enhance patient engagement and reduce trial dropout rates.

Types of informed consent in clinical trials

In clinical trials, there are several key types of informed consent:

1. Informed Consent: The primary type where participants are fully informed about the study and voluntarily agree to participate. This involves:

• Providing detailed information
• Allowing time for questions
• Obtaining voluntary agreement

1. Proxy Consent: Given by a legal guardian or representative on behalf of someone who cannot make decisions for themselves. This applies to:

• Minors
• Individuals with mental illness
• People with cognitive impairments

1. Explicit Consent: Obtained through a clear, specific written agreement

1. Implied Consent: Typically used in low-risk situations where participation is routine, such as filling out a survey

Roles of Electronic informed consent in clinical trials

1.Participant Education and Engagement

The electronic informed consent modifies abstract trial descriptions into functional and multimedia experiences. This incorporates the use of videos, graphics, and quizzes aimed at improving comprehension and involvement of the participants.

2.Convenience and Accessibility

eConsent offers an option of off-site participation, thus patients can sit anywhere to read and sign consent form. This digital model removes geographical constraints and enhances the number of patients who can participate in the studies.

3.Workflow Efficiency

deals. Digital consent systems perform the functions of documentation automatically hence saving on time and reducing workloads and human errors. With the help of these systems, creation of instant audit trails and simple management of protocol versions are possible.

4.Compliance and Legal Validity

The platforms for electronic informed consent also guarantee regulatory compliance via the combination of strict architectural controls and the capture of the person’s signature. Such systems help in great measure to minimize protocol deviations and improve the legal aspect of all clinical trials.

5.Participant-Centered Interaction

There is a pivotal role of eConsent in enabling contact to be maintained between researchers and participants throughout the duration of the trial. In addition, eConsent ensures transparency by disseminating periodic general information about the trial and the conclusion of the trial performance.

electronic consent regulations

• Regulatory Framework: The Common Rule and FDA regulations mandate transparency and understanding in obtaining informed consent, with specific requirements for electronic consent documentation.
• Consent Elements: E-consent forms must include all standard informed consent elements, matching the requirements for traditional paper-based consent processes.
• Identity Verification: Regulations permit electronic signatures using methods like digital signatures, biometric identification, and username/password combinations.
• Institutional Review: IRBs must approve e-consent processes, ensuring the electronic system meets legal and ethical standards for research participant protection.
• Technical Compliance: For FDA-regulated research, e-consent systems must be Part 11 compliant, with specific documentation requirements for system verification.
• User Control: Electronic consent frameworks should provide users granular control over their data sharing, with clear scope and purpose of data access

FDA guidelines for monitoring clinical trials

The FDA provides complete guidelines for monitoring clinical trials through a risk-based approach:

• Develop complete risk-based monitoring strategy
• Ensure patient safety and informed consent
• Maintain rigorous data collection standards
• Implement protocol compliance verification
• Conduct regular site performance assessments
• Validate investigator research capabilities
• Monitor adverse event reporting mechanisms
• Establish data integrity procedures
• Perform periodic risk mitigation evaluations
• Ensure Good Clinical Practice (GCP) standards

Informed consent in clinical trials of drugs, biologics and devices

Informed consent is a cornerstone of ethical clinical trials, ensuring that participants are fully aware of the study's purpose, procedures, risks, and benefits. It is crucial for trials involving drugs, biologics, and medical devices to maintain transparency and compliance with regulatory guidelines.

What Is Informed Consent in Clinical Trials?

Informed consent is a process where participants voluntarily agree to take part in a clinical trial after receiving comprehensive information. This process ensures respect for participant autonomy and aligns with Good Clinical Practice (GCP) guidelines.

Key Components of Informed Consent:

1. Purpose of the Study: Clear explanation of the trial's objectives.
2. Risks and Benefits: Detailed information on potential risks, side effects, and expected benefits.
3. Study Procedures: Overview of interventions, such as administration of investigational drugs, biologics, or device usage.
4. Participant Rights: Right to withdraw anytime without penalties.
5. Confidentiality Assurance: Details on how participant data will be protected.

Informed Consent Process:

1. Information Delivery: Provide an easy-to-understand document explaining the trial.
2. Interactive Discussions: Address participant questions and concerns.
3. Voluntary Agreement: Obtain signed consent without coercion.

Regulatory Guidelines for Informed Consent

1. FDA Regulations: Ensure compliance with 21 CFR Part 50 for clinical trials in the USA.
2. ICH GCP Guidelines: International standards for ethical trials.
3. Ethics Committee Approval: Informed consent documents must be reviewed and approved by an Institutional Review Board (IRB).

Importance of Informed Consent

Informed consent not only safeguards participant rights but also builds trust in clinical research. This process is vital for the successful execution of clinical trials involving investigational drugs, biologics, and devices.

Conclusion:

“eConent: Electronic Consent Clinical Trials” are advancing patient retention by enhancing participant understanding, convenience, and engagement. By Taking advantage of digital tools like multimedia resources, remote accessibility, and automated workflows, eConsent addresses traditional challenges in informed consent processes. These innovative platforms streamline consent procedures, improve compliance, and foster transparency, ultimately contributing to higher retention rates and more efficient clinical trials.

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