This swift action taken by the regulatory agencies was in direct response to global concerns around assuring the safety of clinical trial participants, maintaining compliance with good clinical practice (GCP) and minimizing risks to trial integrity during this unprecedented time.
These latest regulatory guidelines permit sites, sponsors and CROs to adjust their study operations to meet changing conditions for ongoing trials, however there are conditions that must be met in order for new solutions to be considered.
What You Need to Know
Both sets of guidance outline important information the clinical trial industry needs to know now about continuing existing clinical trial operations and considerations for new study start up during the COVID-19 pandemic.
- Ongoing Risk Assessment: The EMA legislation states that “safety of the participant is of primary importance, and risks of involvement in the trial, in particular with added challenges due to COVID-19, should be weighed against anticipated benefit for the participant and society.” Both US and European regulatory agencies recognize that local circumstances could lead to a change in risk assessment. Sponsors must use tools available to monitor local markets to ensure that site and patient personnel are safe to continue participating in the clinical trial.
- Protocol Amendments: The FDA says that “changes to the protocol or investigational plan to minimize or eliminate immediate hazards or to protect the life and well-being of research participants (e.g., to limit exposure to COVID-19) may be implemented without IRB approval or before filing an amendment to the IND or IDE, but are required to be reported afterwards.” On the other hand, the EMA states that while they acknowledge that the COVID-19 situation is likely to introduce more protocol deviations than normal, these deviations should be managed in accordance with the sponsor's operating procedures. They cite that a “proportionate approach will be taken by the GCP inspectors when such deviations are reviewed during inspections,” in the best interest of patient safety.
- Changes to Study Conduct: Both FDA and EMA guidance advocate for sponsors to evaluate alternative methods for safety and efficacy assessments, specifically changing physical visits into phone or video visits or providing for alternate locations for assessments, including local labs or imaging centers that are further from a risk zone or closer to the individual’s home. Both also recommend evaluating other ways of getting the study treatment to the participant, such as bringing medicines and equipment to the individual’s home or employing home health services. Implementing video visits or other digital communications could serve as temporary alternate monitoring measures amidst the coronavirus emergency situation. Results of altered monitoring and review measures are required to be reported to sponsors and captured in clinical study reports.
- Communication with Sites: The EMA notes that any changes in trial conduct should be “communicated clearly to investigator sites.” Should any of the formerly agreed-upon study conduct rules be amended, the sites should be notified and implications made clear.
- Reimbursements of Expenses: The EMA also notes that if urgent measures for the protection of patients cause expenses to be incurred by the patient, they should be compensated by the sponsor via the investigator. Similarly, if new study conduct causes expenses for the site (such as the use of a delivery service for medication, materials or site personnel), the site should also be reimbursed. These payments should be made in accordance with national legislation and/or guidance.
- Material Revisions: Should you implement new approaches to support your study, it’s essential for sponsors, Cis and IRBs to update governance documents to showcase new study monitoring methods, travel policies, adverse reaction documentation and more.
Greenphire is here to help.
These are unsettling times, and a priority for us right now is to do our part to help make sure the clinical research community feels educated and supported, by providing reliable information and links in our new COVID-19 Resource Center.
Despite the global crisis, Greenphire’s suite of solutions are operational worldwide serving sites and patients, sponsors and CROs with patient reimbursement, travel and site invoicing systems that can help keep studies solvent and access to clinical trials intact.
We’re also using this time to listen to clients’ immediate needs. Whether that be in client conversations or surveys, Your feedback with be used to incubate ideas and innovate on new solutions to help meet the demands of this challenging environment, while adhering to the guidance outlined above. These include:
- Data substantiation: As the FDA cited, changes in visit schedules, missed appointments and more may lead to missing information. You can rely on the Greenphire reporting set to provide insight into patient visit and reimbursement activity taking place across regions and countries.
- Alternative travel options: Planes and trains not operational? Let’s shift to car service or Lyft rides. We’re actively working with sponsors and CROs to adjust their travel policies to respond to live and local market conditions.
- Expense reimbursement & communication: Perhaps now more than ever, patients may have expenses related to their study visits. As the impact of the virus unfolds, we expect to see new categories of out-of-pocket costs, whether that be childcare or new methods of transportation. Our solution is flexible and scalable to help you ensure that patient access to their study remains unfettered.
Ensuring that your patients remain safe and enrolled in your study are pivotal, and we’re committed to doing our part to ensure that we help you meet your goals.