There are a variety of aspects to consider when having a patient candidate enter a clinical trial. While signing a consent form is one of the first steps to entering a study, the informed consent process should be ongoing throughout the trial and provide education, face-to-face communication and deliberation time for the participant. The traditional method of paper consent only fulfills the educational requirement by providing a written description of the study. Even so, the initial consent form is not interactive; it doesn’t allow participants the opportunity to review the materials as often as needed before or after entering the study, and it doesn’t provide individualized assessments for the participant to decide whether or not they want to enter.
Clinical trial management solution Clinical Reach offers an alternative method for recruiting patients through the use of eQualification and eConsent. Integrating innovative digital recruitment strategies offer major advantages for sponsor organizations and will continue to foster patient engagement throughout the clinical trial. eQualification and eConsent, for example, are centralized, meaning that all data collected lives within Clinical Reach’s secure cloud database. Sponsor organizations and physicians are instantly given access to data collected during recruitment such as the number of participants that have consented, countersigned or withdrawn from eConsent.
As of 2012, research shows that the top 50 pharmaceutical companies are engaged or are planning an eConsent strategy. All of the top 10 pharmaceutical companies reported that they had an eConsent strategy in place for 2013-2014. For sponsor organizations that are still on the fence about making the switch, we’ve compiled our top reasons for adopting eQualification and eConsent for upcoming clinical trials.
Benefits of eQualification
- If the participant requires more explanation of a concept or they do not know how to answer a question correctly, they are able to reinforce their understanding by utilizing information resources within the qualification page.
- Interactive links comprised of explanatory audio and video examples can help a patient candidate self screen for the clinical trial. For example, a candidate can view laboratory tests or procedures that will be conducted during the study to determine if it’s a regiment that the candidate is suited for.
- Data captured during the eQualification process allows physicians to make an assessment of the candidate’s understanding of the study. The physician is able to provide clarification on uncertain subjects before having the candidate proceed to the eConsent page.
Benefits of eConsent
- Web-based access to the eConsent form allows patient candidates to discuss the consent materials with family members first and ensures the certainty of entering the study. Patients that have a high comprehension of the clinical trial such as research goals, risks, benefits and required medicines, are more likely to remain as a participant for the remainder of the study.
- The data collected during the consent and self screening process is centralized, allowing stakeholders real-time access. This data can be compared across multiple studies, can target specific demographics and provide insights to potential adverse events.
- Data from eConsent also reveals where candidates are struggling. Perhaps a certain qualification question is causing multiple candidates to withdraw from the self screening process or maybe candidates are having difficulty understanding a word or phrase. Over time, this data will help sponsors refine the consenting process which will save time and money for future trials.
To learn more about studies that Parallel 6 has integrated Clinical Reach and it’s eQualification and eConsent modules, contact us today.