Director, Strategic Supply Solutions
The COVID-19 pandemic has made society very aware of the need to be flexible in daily life. Every part of “normal” everyday life is disturbed. Clinical trials and the traditional way of conducting them were no different. Flexibility has become an immediate need for sponsors, CROs, clinical sites, and patients. Quick adjustments needed to be made and new ways found to ensure that patients were adequately cared for. Monitoring of the clinical sites continued to be administered, and drug supplies and accountability were maintained. Many clinical sites acted as the shipping department trying to ensure that all patients received their medication safely and on time. CRAs conducted remote monitoring visits, virtual site tours, and virtual accountability reviews. Sponsors quickly began to rethink their direct-to-patient (DTP) approach as patients increasingly asked for their study drugs to be delivered to their homes.
The use and adoption of DTP may have grown faster due to the pandemic, but the general trend towards the decentralized clinical trial (DCT) / DTP model was on the rise before 2020 and is expected to increase significantly over the next few years. As more DCTs come on board, it is important to remember that clear roles and responsibilities, as well as experienced management, are critical to success. Sponsors who have more flexibility in their protocol designs, standard operating procedures, and quality control processes can effectively benefit from using the DTP model. The DTP model can help reduce the risks associated with patient recruitment (including diversity), patient retention, and compliance with general study times and overall budget. A well-planned DTP study can benefit patients and sponsors, but this model can prove to be more complex than the traditional model. An efficient approach requires a rethinking of Standard Operating Procedures (SOPs) and nearly every other aspect of traditional experimentation management, including protocol design and dosage windows. Before the protocol is finalized, consideration should be given to building a diverse team that is familiar with all aspects of study oversight and the supply chain.
Risk reduction in DTP studies
The decentralized model as well as the traditional location-based model with a DTP component can open sponsors to new risks in addition to those of the conventional model. Some concerns, which are fairly straightforward to resolve in traditional studies, can create problems for unprepared sponsors of studies with a DTP component. By identifying the risks associated with a trial in advance, sponsors can mitigate those risks and position themselves to better leverage the benefits of DTP care for their clinical trial surgeries and patients alike.
Successful studies begin with a clear understanding of the goals associated with using DTP and a knowledge of regional requirements and possible restrictions. DTP regulations vary significantly from country to country. Therefore, it is important to work with local experts to understand what is and cannot be done in a particular region and how important tasks such as consent and the content of clinical labeling can be addressed. A different plan is strongly recommended for each country. There is no one-size-fits-all approach to DTP delivery globally. Individual country plans make it easier to adapt from country to country if necessary, without having to interrupt or delay the entire study.
However, there are a few elements that are the cornerstones of all desktop publishing deployments. When using a CRO, it is important to choose one that has a solid track record of conducting decentralized studies. Equally important is having a strong clinical delivery partner with DTP experience, as is a flexible interactive response technology (IRT) capable of managing the unique needs of DTP, especially in a hybrid model that consists of on-site deliveries to patient directly to patient consists of patient consignments from a depot and delivery of on-site visits.
All parties need to communicate well and have a clear view of their roles and responsibilities. If all the details are not confirmed, no matter how minor at first glance, and otherwise prepared in advance for the study, assumptions and other problems may persist, which can lead to surprise costs and delays.
Specific issues teams need to consider include handling patient information, how to prevent the study drug from being dispensed to anyone other than the participant, requirements for temperature storage / distribution, return / accountability, and involvement in home health care. Providers with access to patient information should be vetted to ensure that they comply with all local data protection laws and that only those who need to “know” the patient information to perform a specific task have access. Couriers may be instructed to deliver only to the named patient or agent in order to reduce some of the risk, including the safety issues that could arise if the drug were delivered to minors, for example. The handling of returns and the monitoring of accountability by the credit rating agency require a different approach. Virtual review of documents and reports may be required if the clinical site does not store the drug. Involving home health care can also help minimize some risk: they can make sure the patient is taking the medication appropriately, and they can also help pack returns and fill out voting papers.
Virtual “visits” on the day of drug delivery, combined with tests and task reminders in a mobile app, can help reduce the risk of a patient receiving and taking the wrong medicine and ensure a full understanding of how and when the medicine was taken should be medicinal.
How DTP studies reduce operational risks
Conventional clinical trials have their own risks. The COVID-19 pandemic exposed some of the risks of the location-based model, but it is far from the first event to disrupt patients’ ability to receive the study drug in a timely manner.
Risk mitigation is possible when DTP is used as a supportive component in the decentralization of clinical trials. By decentralizing studies, sponsors can reduce the risk of slow registration and dropouts. DCTs eliminate the need for subjects to be physically close to a clinical site to participate, thereby expanding geographic area and lowering the socio-economic and diversity barriers that discourage, lock in, or cause patients to enroll. that they will be too big under load.
Decentralizing studies also helps patient policy compliance by preventing missed visits and increasing the diversity of the pool of potential participants. Overall, the benefits support quick enrollment and strong retention that improve adherence to general study schedules and budgets.
Faster recruiting and increased retention are just two of the ways in which decentralization and DTP from a central location can lead to cost savings. Sponsors also benefit from having to produce fewer drug surpluses, as there are no inventory locations in the event a patient signs up, reducing the amount of study medication that may be wasted over the course of the study. In addition, sponsors may see a reduction in clinical site fees for storage, visits, and handling. These savings will help offset any upfront costs associated with using DTP.
Putting DTP into practice
The benefits of DTP are now well validated. The COVID-19 pandemic has accelerated the transition to the model, showing everyone how to improve the operation of clinical trials and reduce risk. As DTP becomes an increasingly routine part of drug development in the post-pandemic, sponsors and their supplier partners need to keep abreast of evolving best practices related to using this approach and the ways in which DTP can be used to support operational mitigation risk and maintain patient focus.
Sponsors meet this challenge in a rapidly changing sector that is regulated by different countries by working with experienced clinical care providers who have a track record and knowledge of the evolving DTP area.