Finding ways to operationalize clinical trials – Keeping staff and subjects safe
The current Pandemic has impacted the way we live and work. It’s impact is felt on every aspect of what we do and no industry is immune. The medtech clinical trial arena in large part depends on the participation of people and interaction/visits. These unprecedented times require us to adapt our existing procedures with caution. The challenge many device companies face is the continuity of their work which in large part depends on participation by subjects and to navigate this while complying with regulations and ensuring the safety of staff and subjects. This is not an easy task as the problem is novel to all.
The FDA and the EU have several considerations to guide sponsors and investigators through this situation however the common thread in these guidelines is the focus on safety of participants, maintenance of Good Clinical Practice, minimizing risk to trial & data integrity and documentation of reasons for protocol deviation. To help alleviate certain challenges many are looking toward technology, to see where it can help. Below we have listed a few ways to leverage modern technology to keep trials running.
Protocol Deviations as a result of skipped/missed visits
Carefully Assess & Amend
Protocol deviations include missed or rescheduled visits in studies and should be captured on file when they occur. Deviations typically do not entail an increased risk for the patient but might affect the study outcomes. To deal with protocol deviations, study teams should plan ahead by including a Protocol Deviation Form as a part of their Case Report Form. However, in cases where this has not been done, an amendment to the eCRF might be necessary.
SMART-TRIAL can support studies with its unscheduled event functionality. Users can include the Protocol Deviation Form as an “Optional Form” which can be activated on a subject level as an unscheduled event. This can be setup through the Process Creator
In cases where studies have not included a Protocol Deviation Form as a part of their initial study set up, it might be necessary to conduct a Study Amendment. These can easily be done within a matter of minutes and will not affect other data collection in the study. Once a Protocol Deviation Form has been created (either in this study or saved to your profile) it can be added to the Unscheduled Event Optional Form section. Study Amendments are initiated by clicking the Study Amendment Button in the bottom left corner of the Study Setting Screen.
Keep patients engaged with electronic Patient-Reported Outcomes
Due to concerns with COVID-19, many patients are either unable or unwilling to travel to sites for scheduled visits or sites
To accommodate for the lack of on-site visits and missing data, sponsors should evaluate the use of electronic patient-reported outcomes (ePRO). ePRO can be of great benefit to otherwise missing data directly from subjects remotely.
SMART-TRIAL provides a simple way to send questionnaires to subjects directly to their email or mobile phone via SMS, where subjects can answer the questionnaires at home or on the go. This works on most modern computers and smart devices like tablets and smartphones. Data is sent directly to the SMART-TRIAL Study and stored securely in compliance with regulations and industry standards
We are seeing our clients make full use of the SMART-TRIAL ePRO capabilities for subjects that are enrolled to answer questionnaires on their own smartphone . This allows them to go on capturing data. They are then opening deviation forms for visits that were scheduled and are now phone calls .
- BYOD – Send participants surveys/questionnaires and allow them to fill them out on their own device/smartphone
- Consider using Phone calls and video calls as much as possible as an alternative
Watch a quick video on how easy it is to use the SMART-TRIAL ePRO module
Keep patients informed
Now, and probably more than ever, it’s important to keep study participants informed of how the pandemic impacts their study participation and treatment. Many are left confused about how their participation will continue, if at all, so it’s important to share information with subjects on a regular basis to keep them engaged. Subject (patient) engagement is easy to set up in SMART-TRIAL. By setting up Information Events in a Study, a study manager can send emails and/or SMS to individual subjects, or all subjects, with relevant information and content on their study participation.
While many clinicians have their hands full in treating critically ill covid-19 patients, others are left with fewer patients. This can provide some medical manufacturers with a chance to reach out to clinical professionals to gather information and feedback on their products. This can be helpful especially regarding design of a Post-Market Clinical Follow-Up plan.
One way to approach this is for example is through Surveys, where SMART-TRIAL can be used to send questionnaires to clinical professionals to answer a set of questions on their use of a device, or to provide case-by-case information on the device’s clinical performance. Depending on the local legislative environment and if designed correctly, this might offer medical device manufacturers a chance to gather clinical data for PMCF use, without having to go through ethical approvals.
SMART-TRIAL is centered around subjects, and a subject can be a patient, clinician, or any other participant. Thus, the SMART-TRIAL ePRO can and has been utilised, for much broader data collection than just PROs. It is flexible and can be set up in different ways based on your study requirements.
When Site visits are not allowed or prevented (Monitoring)
Leverage Verification I & II
Pandemics ,weather conditions, cancelled flights etc. can prevent monitors from making their planned on-site visits. Being prevented from visiting the site can force device companies to change their monitoring strategies to a remote based strategy.
SMART-TRIAL offers two types of monitoring/verification features (Verification I and II) that can be used for a variety of things such as Source Data Verification (SDV), remote monitoring, site monitoring ,
These features can enable you to mark variables and visits that you have remotely monitored for data consistency, validity, etc. Furthermore, if you can get remote access to hospital information systems you can use the verification functionality to do remote SDV.
Remote enrollment with Informed Consent
One of the major challenges is enrolling participants into trials with informed consent when current consent methods are not feasible. Additionally, many companies are going back to the drawing board to map how participants are enrolled. While technology cannot resolve all issues it can be used in certain areas of the pipeline to patch problems. Authorities have recommended that any “validated and secure electronic system already used in the trial for obtaining informed consent can be used as per usual practice and if in compliance with national legislation”. SMART-TRIAL offers an e-consent integration to streamline the informed consent process, contact us to implement this in your studies.
What we do and how we can help?
While many of our customers are adapting to the “new normal” the impact of this on Clinical Trials indicates a push toward technology. From our inception SMART-TRIAL has been committed to the MedTech industry. Now more than ever we stand behind our vision for All MedTech companies to collect high-quality clinical data. While these unprecedented times have and continue to have an impact on business, SMART-TRIAL remains fully committed to serving the Industry and professionals that rely on us the best we can.
Contact us to learn how we can support your medical device and its clinical data.