- Protect participants and study staff
Consider minimizing exposure for study participants and reducing in-person appointments that would require the participant to engage in non-essential travel. Many elements of the study visits can be supported with virtual technologies such as remote monitoring.
Patients that are chronically or critically ill and at risk of harm if the trial is paused cannot continue their participation in a virtual way. Consider arranging private transportation for the participant to come to the trial site, if it is open. Respect the wish of the patient if they no longer feel comfortable to continue their participation in the trial.
As far as the research staff is concerned, being on-site may expose them to a risk that can be avoided. As recommended by the regulators, physical visits should be replaced with phone or video sessions where possible, recruitment should be suspended, home monitoring should be envisaged. In-person visits should be replaced with phone or video calls but consent must be given for trial operators to remove sensitive information from the trial site, or access it remotely. Consider using local laboratories, outside of the trial facility, to complete critical laboratory tests, imaging and other diagnostic testing if the patient is unable to get to or unsafe at the facility hosting the trial. Even in places with emergency measures, specimen collection centers are likely considered essential services and may remain open.
- Conduct trial risk assessments
Regulators are asking researchers to conduct detailed risk assessments, giving priority to the safety of trial participants. This means sponsors need to prepare for inevitable changes to processes and to protocols.
Make sure to review the risk to study participants. If the trial itself is beneficial to the health of participants, then traditionally the trial would need to continue so as not to endanger patients’ health. This is valid for oncology studies or rare disease studies, where the patients may derive great benefit from continuing treatment. Conversely, if visiting the hospital site would be detrimental to a patient’s health, that might be a point where you stop enrollment.
- Simplify protocol
Each and every clinical trial in the company’s pipeline needs to be reviewed and assessed in order to decide whether to be paused, cancelled or supported with virtual components.
The clinical trial data and how it can be collected is an important consideration, i.e whether it is a must-have and needs to be collected on-site, whether it can be collected remotely, or not needed. If possible, sponsors should consider implementing trial designs with remote startup, monitoring, management and closeout.
In deciding how specific clinical trials should be handled during this pandemic, John Hopkins advised the following guidance:
- Leverage technology to go virtual
To keep a clinical trial going on through the pandemic, existing digital technologies can be plugged into some of the elements of the study. Many consent forms allow flexibility but just in case companies need to review their original consent forms and see if participants have agreed on a particular approach.
It is crucial to involve the legal and data protection departments as early as possible in order to go through the approval process of introducing new technologies:
Over the past several weeks, pharma companies, clinical research organizations, universities and more have announced the suspension or delay in enrollment of some clinical trials due to concerns of the spread of the pandemic. This was also recommended by FDA, EMA and other national regulators so as to protect patients’ safety and prevent further infections. Due to the massive closure of sites, recruitment has been paused by many sponsors and trials related to Covid-19 agents have been prioritized.
It seems patient recruitment, enrolment, and engagement levels are the most common pressures trial managers are tasked with that virtual trials can help solve. If people can register through eConsent and enrol on a study from the comfort of their own home rather than visit a site, the burden is instantly reduced.
With so many people confined to their homes and health services at capacity, a virtual approach would not be as impacted as the site-based one is. We’ve talked in detail about the Direct-to-Patient recruitment and engagement approach in our previous blog post so if you are interested to explore the Do’s and Don’ts of this model, check it out here (hyperlink the article on the Do’s and Dont’s of Direct-to-Patient recruitment once published).
Obtaining remote consent was before Covid-19 a way to ensure better patient comprehension and higher retention rates. One of its benefits is that it can speed startup and reduce workload on sites. In light of the current crisis, however, eConsent is even more needed as in-person visits are discouraged and clinical trial teams are advised to employ different solutions that allow their trials to function remotely. If you are interested in exploring eConsent solutions, make sure you check the list of providers we have created on our blog.
Digital alternatives to capturing patient reported outcomes from a matter of convenience quickly transformed into a life-saver for clinical trials once Covid-19 made patients stay at home and sites to close. Not only can ePRO/eCOA solutions help your trial stay on track but they can also reduce costs and save you some time. We created a list of providers which will help you ensure the survival of your trial while also taking your operations to the next level.
Now more than ever sponsors and researchers will be looking for technology to support them in remote source data validation and remote monitoring, so consider what tools are needed to ensure monitors are effective while working remotely.
Processes must remain compliant with regulations (e.g. no unencrypted PDFs with personal data being exchanged), and researchers should carefully assess whether they are using compliant technology for this purpose, such as HIPAA-compliant screen-sharing technologies. We composed a list of platforms and devices geared towards healthcare providers but designed with the patient in mind to help you find the best option for your trial.
As recommended by regulators, where a trial participant is unable to attend the site, other measures, such as home nursing, if possible given social distancing needs, or contact via
phone or telemedicine means, may be required to identify adverse events and ensure continuous medical care and oversight. For years, companies have been integrating clinical trial expertise with in-home nursing to bring the trial to patients wherever they live, work, study or travel. In a situation of a pandemic like the coronavirus disease, such solutions can be crucial for keeping clinical trials moving and patients being taken care of. A round-up of recommendations for home nursing and telehealth providers is listed on our blog.