A successful clinical trial can only happen when it has recruited and retained an adequate number of study participants. Patient enrollment for a trial can often become a difficult and a daunting process without the completion of which a trial cannot take off. Oftentimes, vigorous strategies must be mobilized for this very instrumental segment of the trial. The enrollment process is registering or entering a patient for a clinical trial. Before the formal enrollment, a patient goes through screening; wherein a patient is checked for eligibility parameters. Once all the formalities of this step are fulfilled, the patient is asked for formal, informed consent. A patient’s consent can even be required during the trial when a course of treatment is to be changed for a desired outcome.
Till recently, patient/subject consent for trials and medical interventions was primarily on printed paper forms combined with a briefing with the medical practitioner - which would remain unrecorded. Ultimately, the participant would be somewhat uninformed as his recall and comprehension of what had been told to him is deficient. Standardized participant information and consent forms have resulted in more complex documents. Another shortfall of these forms was that they were targeted more for fulfilling regulatory requirements than for the benefit of the participating subjects. These forms were, therefore, lengthy and confusing, thus being a significant reason for patient reluctance to join the trial.
Electronic informed consent (eConsent) is aimed at garnering the same amount of information from the subject but in an electronic format that includes the use of electronic/digital devices like multimedia components such as images, audio, video, diagrams, reports, call-out boxes and a digital signature, passive and interactive Websites, podcasts, biological recognition devices, and card readers which facilitates and expedites the consenting process. Simply put, a clinical trial eConsent is a digital consent process that studies participants undertake to enroll themselves in the trial and then throughout it to confirm their comprehension. These can be used for site-based traditional consent or at-home, remote consent. Signant’s options include support for the beginning of the studies or the closing phase; the trial could be confined to the local or global population segments.
Electronic consent forms have multiple functions: they fulfill a legal requirement, work as a gatekeeper, and act as an audit trail.
In case of a dispute between the patient and the researcher or provider, an eConsent form stands in as evidence that the patient had given informed consent to the administration of the procedure.
It allows only the signatories to access patient information and health records. These digital forms protect patients’ privacy and prevent the circulation/distribution of patient records unlawfully and randomly.
An audit trail authorizes only clinicians participating with the subjects to access the patient records. By agreeing or confirming their comprehension of the specifics of the eConsent, the accessing clinicians agree to a patient’s wishes regarding how his records are used.
eConsent forms have a user-friendly design, typically featuring multimedia elements such as videos, animations, and interactive quizzes. These inclusions simplify complex medical information and ensure that patients fully understand the study's purpose, risks, and benefits. Furthermore, eConsent platforms often offer language translation services, catering to a diverse patient population and promoting inclusivity in clinical research.
eConsent forms can be accessed remotely via smartphones, tablets, or computers, allowing patients to complete the process at their own pace and in the comfort of their homes. This flexibility eliminates the need for in-person visits, reducing travel time and expenses.
eConsent platforms facilitate real-time tracking of consent status, enabling research teams to address any patient concerns and regulatory compliances promptly. Undoubtedly eConsent forms significantly allow a patient ease-of-use and comfort and assure a patient-centered approach in clinical research participation.
Patient consent is extremely important when it concerns the line of treatment or the right care to be determined for the patient. A healthcare center or hospital is ethically and legally bound to administer quality treatment with the patient’s consent. The patient has to be in the know of things. Keeping this in mind, the practitioner or researcher must discuss the course of action and ensure that the patient/subjects comprehend everything. Accordingly, the patient has to sign a consent giving his acquiescence to whatever has been discussed between him and the medical practitioner concerning the administration of medical treatment. In addition to being signed, these documents must be safely filed to be referred to when the medical practitioner is questioned for medical malpractice.
eConsent forms are stored on a server or online, and this secures them from getting lost or hacked, as the cloud-based software has its cybersecurity and a reliable backup system. Patient care by the healthcare staff is greatly improved since they do not have to worry constantly about the paper form being misplaced/damaged or lost. Accessing patient record online is easier and time-saving than wading through loads of paperwork. The patient is well-informed about his treatment administration and can adhere more faithfully to the doctor’s instructions, resulting in very positive outcomes. It is comforting to the patient to know that his records are safely stored, and recourse to the law can be taken in case of an adverse effect of a treatment.
Hospitals and trial sites often update their consent forms. A paper-based consent form must go into reprint with every update without adding subsequent processes. eConsent forms can be updated and changes made with little investment of time and energy. It protects the patient from being subjected to an outdated version of the form and consequent lacunae in treatments.
Recent studies suggest that patients who are actively engaged and continually informed of the course of the trial are successfully retained. eConsent process takes cues from proven educational methods. As per these, the patients are given the bandwidth to ask questions or highlight sections of the form that eludes their understanding. This facility makes the whole process interactive and reinforces comprehension. Physicians/coordinators, too, can identify the problem in the document and discuss the section in detail. It stimulates the patient/physician relationship, thus significantly reducing patient anxiety and reluctance resulting in fewer dropouts. In a CISCRP survey, 35% of patients reported that the consent form appeared difficult to understand. A definite red flag to patient enrolment.
There are hurdles galore in the screening process that can discourage a prospective participant from continuing participation. In a situation where screening and recruitment can be automated, it would be less cost sensitive and time-consuming; for both the sponsor and the patient participant. Automated screening can be done with a patient’s EHR (Electronic health record), greatly improving speed for patient identification, streamlining patient recruitment, and increasing patient enrollment in a trial. Automated screening reduces the total screening time, thus saving expenditure on human resources and time lost.
Drawing patients for clinical studies requires implementing strategies. A digital advertising campaign with a landing page for the particular trial is perhaps the most effective. It means that a clinical trial will have its standalone web page specifically created to handle this specific trial. It will have its goals, processes, and CTA or call to action, all in one place. The patients will have everything spelled out for them in one place. They will not have to research or hunt up material for referencing or waste time trying to decode things for themselves. The most essential component of digital marketing is the call to action. This step encourages and entices the patient to move toward participation. The patient opts in and then can be contacted for participation.
Landing pages are used to maximize the number of patients leaving contact information. These pages are designed to remove friction and nudge the patient toward an opt-in. A visitor has to click on a link to be taken to a landing page. The landing page could bring in 10 to 100 patients who want to be contacted.
It cannot be denied that digital marketing/advertising does affect the efficacy of patient recruitment and enrollment methodology. It takes the patient-centric procedure to the next level. The landing page personalizes the content without pushing material that is of no use to the patient. It economizes on timelines and budgets as it can work on subdomains of the leading site. When a study's purpose and roadmap are explained on the landing page, it can ramp up the recruitment drive. A patient suffering from a particular disease would respond without delay to call-to-action if the study is well-explained on its landing page.
For the screening of patients online questionnaire or a survey may also be taken by the prospective/interested subjects. These can be posted on the trial site, the sponsor’s website, via Facebook, or even the landing page. Online questionnaires confine themselves to general patient information, including contact details. It could be phone number, email id, etc., The patient is then interviewed by the trial staff and further screened. The patient can be deemed unfit at any interview juncture and excluded. Registration of a subject will only happen if all the criteria are cleared including that of informed consent.
Studies have found a participant’s comprehension of critical areas of study, namely the
are sufficiently clear to allow them self-completion of eConsent forms using mobile platforms.
A mobile platform is enabled with visual, auditory, and touch modes of accessing information and interaction, for example, listening, watching an explanatory video, or participating in an interactive session. These technologies provide just-in-time information and facilitate a self-determined pace of learning, even allowing repeated explorations of consent topics by the prospective subjects. Smartphones can be used to fill eConsent forms remotely and independently, and a mobile app would do the needful.
Self-scheduling is fast becoming a facility much appreciated by patients/subjects. With self-scheduling tools, patients and participants can book, alter or cancel their appointments from their smartphones or computers. The benefits of patient self-scheduling significantly ensure patients turn up for the appointment, reducing resource wastage and enhancing operational efficiency. Typically self-scheduling tools contain features that alert/send notifications and have calendar reminders. Above all, patients/ participants are more inclined to keep an appointment when choosing a time slot.
There is increased operational efficiency accompanying self-scheduling. The staff is left free to carry out more productive tasks than working on setting up appointments depending on the patient’s medical history or outcomes of previous administrations.
Software vendors offer patient portals that integrate EHR and billing systems and allow patients to schedule appointments at their convenience.
There are cloud-based standalone systems that are affordable and accessible for a trial working within a limited budget. These systems are specifically for patient self-scheduling, and health apps can also be used to fulfill the purpose of the participant.
Patients/participants can be encouraged to self-schedule through specific campaigns. Emails can be targeted to participants with a ‘schedule now’ option, clicking on which would allow them to self-schedule.
Telemedicine, too, has worked towards effective self-scheduling of eConsent by the prospective participants. Telemedicine services are channeled through video conferencing or other virtual technologies, which helps save the care providers' resources and considerably reduces the cost of the treatment. Telemedicine can be employed to target participant populations in remote areas.
We cannot deny that integrating eConsent into clinical trial processes has hugely simplified patient enrolment, streamlining workflows and delivering notable efficiency gains. eConsent empowers patients with increased access to information, fostering informed decision-making that comforts and satisfies the participant. The ease of use, user-friendliness, and multimedia capabilities of eConsent platforms facilitate comprehension and retention of essential trial details, resulting in more confident and engaged participants.
Furthermore, eConsent reduces the administrative burden on research staff by automating various time-consuming tasks, such as document tracking and version control. Clinical trial teams are, therefore, more free to focus on critical aspects of the study while ensuring regulatory compliance. Digital signatures and real-time data management safeguard the integrity of consent records and minimize discrepancies, enhancing data quality and audit readiness. So it becomes a win-win situation for the participant and the trial sponsor.
As a result, eConsent accelerates patient enrolment, reduces dropout rates, and contributes to the overall success of clinical trials. Adopting eConsent is an ethical and strategic imperative, leading to faster and more cost-effective drug development. The continued advancements in digital health technology and widespread acceptance of eConsent will propel the medical research industry forward, offering immense benefits to patients, researchers, and society.
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