Ariette van Strien, President, Marken04.06.20
With the number of people affected by the coronavirus having surpassed one million, the rapid spread of this virus is causing significant challenges to operating clinical trials—and may forever change how future trials are conducted. Clinics and hospitals are less accessible, and it’s often unsafe or too difficult for patients enrolled in clinical trials to travel to sites.
Nearly 30 percent of surveyed clinical trial sites, from a report published by Continuum Clinical, said the novel coronavirus will have a “big” or “extremely big” impact on their ability to recruit patients for new trials and to keep already-enrolled patients compliant with their study schedules. Further, the same report found 56 percent of U.S. clinical research study sites and 81 percent of European sites indicated already-enrolled patients are “much less or somewhat less likely” to continue in clinical trials. Also, as of March 30, nearly 30 biotech or pharma companies have reported a disruption to a clinical trial as a result of the crisis.
This pandemic represents the first time there has been a global disruption to traditional onsite clinical trials. For that reason, finding alternative site solutions and utilizing more innovative approaches are critical to keeping trials moving forward to prevent delays in therapies and, ultimately, to the patients who can benefit from them. That said, the U.S Food and Drug Administration (FDA), the National Institutes of Health (NIH), the European Medicines Agency (EMA), China’s National Medical Products Administration and several other countries have issued guidelines pertaining to the conduct of trials during the pandemic, and are in full support of incorporating virtual services. These services include options where one or all patient visits do not happen in a clinic or hospital, but rather at home.
While COVID-19 is causing many drug and medical device developers to reexamine the way they prepare for these types of crises, incorporating best practices within clinical trial protocols and adapting to virtual models can help to ensure that therapies in development proceed in the presence of a pandemic. More importantly, clinical supply chain and logistics companies are now more integral than ever to help prevent pharma and biotech companies from postponing or delaying clinical studies, by providing patient-centric delivery services and biological sample shipments.
Implement DTP/DFP and HHC services in ongoing clinical trials
As clinical trials are disrupted amid COVID-19, adopting direct-to-patient (DTP)/direct-from-patient (DFP) services can solve rising challenges, which may include quarantines and travel bans, site closings, and protecting patients and site staff. Solutions, such as DTP, can keep clinical trials going and patients safe by making it possible for those patients to have treatments—and in some cases, diagnostic tests—shipped directly to them at home. Through DFP services, biological samples can be retrieved from a patient’s home to be sent to central and specialty laboratories for testing.
Integrating DTP/DFP into clinical trials during this pandemic also includes the use of tracking technologies that can provide patients with updates on home deliveries and pick-up. Real-time updates on the driver’s information, such as location and predicted arrival time, shipment number and delivery address, allow patients to have more visibility with regard to their role in the supply chain process and can help improve protocol compliance.
Moreover, providing a dedicated home health care (HHC) program, where a healthcare professional goes directly to the home, can help make participation in clinical trials as easy as possible for patients. A global network of providers can offer skilled and flexible services, including administering a therapy, performing a checkup or taking samples.
Lastly, planning for the long term is necessary. Currently, pharmaceutical companies are losing weeks of precious time, waiting for the necessary approvals to add these services to their protocols during the ongoing crisis. We cannot predict when clinics and hospitals will recover to a normal state. Therefore, planning beyond the next two or three months, and even throughout 2020, will help to minimize disruptions.
Shift protocol design to leverage virtual trials before launching new trials
Incorporating HHC and DTP/DFP early on in protocol design can help get trials running during periods of uncertainty. For example, a clinical trial that offers DTP/DFP and HHC services with no site visits could relieve perceived burdens for participants and accelerate enrollment. In this instance, study designers should evaluate objectives and question whether a full physical exam is required at every site visit or whether the study supports a virtual model where exams are being conducted by nurses throughout the trial in a participant’s home. If possible, sponsors should consider implementing trial designs with remote startup, monitoring, management and closeout.
Shifting protocol design now to include DTP and home visits will not only mitigate risks during this pandemic, but also will most likely become a standard clinical protocol, whenever possible, moving forward.
Planning for change
Historically, the pharmaceutical and biotech industries have often taken a conservative stance to drug development. But, in times of uncertainty, there lies opportunities for rethinking processes. To reduce disruption to clinical trials, it is the role of the supply chain solutions company to increase transparency and work with pharma companies and CROs to create a mitigation plan. Not having a plan in place could mean losing enrolled patients, resulting in having to restart a trial, which could add years to a drug’s development. That’s why thinking a step ahead is crucial and begins with observing what other countries are experiencing, and applying these efforts across a program.
At Marken we are standardizing our DTP and HHC services to swiftly put mitigation plans into action to allow clinical trials to continue running as best as possible under the current circumstances. Standardizing at the enterprise level allows for adapting to fast-changing logistics networks, which are being impacted by government lockdowns and airlines reducing or halting activities. Through utilization of the UPS network (for which Marken is a subsidiary) and private charters—along with providing additional DTP services to reach patients, as permitted, in each country—our staff is coordinating the delivery of therapies to thousands of patients confined to their homes. Each day a drug or product is delayed in clinical development translates not only to lost revenue, but more importantly, to postponing novel therapies in their journey to the patients who need them most.
Ariette Van Strien is president of Marken. She offers 28 years of clinical research experience from Phase I to Phase IV and has held senior executive roles across global marketing and business development, pricing as well as project management and global operations functions. Ariette’s ability to lead global teams has built strong, strategic relationships with major Pharma and CRO companies. Her extensive work on the central lab and clinical side brings a unique perspective of the supply chain to her current role.
Nearly 30 percent of surveyed clinical trial sites, from a report published by Continuum Clinical, said the novel coronavirus will have a “big” or “extremely big” impact on their ability to recruit patients for new trials and to keep already-enrolled patients compliant with their study schedules. Further, the same report found 56 percent of U.S. clinical research study sites and 81 percent of European sites indicated already-enrolled patients are “much less or somewhat less likely” to continue in clinical trials. Also, as of March 30, nearly 30 biotech or pharma companies have reported a disruption to a clinical trial as a result of the crisis.
This pandemic represents the first time there has been a global disruption to traditional onsite clinical trials. For that reason, finding alternative site solutions and utilizing more innovative approaches are critical to keeping trials moving forward to prevent delays in therapies and, ultimately, to the patients who can benefit from them. That said, the U.S Food and Drug Administration (FDA), the National Institutes of Health (NIH), the European Medicines Agency (EMA), China’s National Medical Products Administration and several other countries have issued guidelines pertaining to the conduct of trials during the pandemic, and are in full support of incorporating virtual services. These services include options where one or all patient visits do not happen in a clinic or hospital, but rather at home.
While COVID-19 is causing many drug and medical device developers to reexamine the way they prepare for these types of crises, incorporating best practices within clinical trial protocols and adapting to virtual models can help to ensure that therapies in development proceed in the presence of a pandemic. More importantly, clinical supply chain and logistics companies are now more integral than ever to help prevent pharma and biotech companies from postponing or delaying clinical studies, by providing patient-centric delivery services and biological sample shipments.
Implement DTP/DFP and HHC services in ongoing clinical trials
As clinical trials are disrupted amid COVID-19, adopting direct-to-patient (DTP)/direct-from-patient (DFP) services can solve rising challenges, which may include quarantines and travel bans, site closings, and protecting patients and site staff. Solutions, such as DTP, can keep clinical trials going and patients safe by making it possible for those patients to have treatments—and in some cases, diagnostic tests—shipped directly to them at home. Through DFP services, biological samples can be retrieved from a patient’s home to be sent to central and specialty laboratories for testing.
Integrating DTP/DFP into clinical trials during this pandemic also includes the use of tracking technologies that can provide patients with updates on home deliveries and pick-up. Real-time updates on the driver’s information, such as location and predicted arrival time, shipment number and delivery address, allow patients to have more visibility with regard to their role in the supply chain process and can help improve protocol compliance.
Moreover, providing a dedicated home health care (HHC) program, where a healthcare professional goes directly to the home, can help make participation in clinical trials as easy as possible for patients. A global network of providers can offer skilled and flexible services, including administering a therapy, performing a checkup or taking samples.
Lastly, planning for the long term is necessary. Currently, pharmaceutical companies are losing weeks of precious time, waiting for the necessary approvals to add these services to their protocols during the ongoing crisis. We cannot predict when clinics and hospitals will recover to a normal state. Therefore, planning beyond the next two or three months, and even throughout 2020, will help to minimize disruptions.
Shift protocol design to leverage virtual trials before launching new trials
Incorporating HHC and DTP/DFP early on in protocol design can help get trials running during periods of uncertainty. For example, a clinical trial that offers DTP/DFP and HHC services with no site visits could relieve perceived burdens for participants and accelerate enrollment. In this instance, study designers should evaluate objectives and question whether a full physical exam is required at every site visit or whether the study supports a virtual model where exams are being conducted by nurses throughout the trial in a participant’s home. If possible, sponsors should consider implementing trial designs with remote startup, monitoring, management and closeout.
Shifting protocol design now to include DTP and home visits will not only mitigate risks during this pandemic, but also will most likely become a standard clinical protocol, whenever possible, moving forward.
Planning for change
Historically, the pharmaceutical and biotech industries have often taken a conservative stance to drug development. But, in times of uncertainty, there lies opportunities for rethinking processes. To reduce disruption to clinical trials, it is the role of the supply chain solutions company to increase transparency and work with pharma companies and CROs to create a mitigation plan. Not having a plan in place could mean losing enrolled patients, resulting in having to restart a trial, which could add years to a drug’s development. That’s why thinking a step ahead is crucial and begins with observing what other countries are experiencing, and applying these efforts across a program.
At Marken we are standardizing our DTP and HHC services to swiftly put mitigation plans into action to allow clinical trials to continue running as best as possible under the current circumstances. Standardizing at the enterprise level allows for adapting to fast-changing logistics networks, which are being impacted by government lockdowns and airlines reducing or halting activities. Through utilization of the UPS network (for which Marken is a subsidiary) and private charters—along with providing additional DTP services to reach patients, as permitted, in each country—our staff is coordinating the delivery of therapies to thousands of patients confined to their homes. Each day a drug or product is delayed in clinical development translates not only to lost revenue, but more importantly, to postponing novel therapies in their journey to the patients who need them most.
Ariette Van Strien is president of Marken. She offers 28 years of clinical research experience from Phase I to Phase IV and has held senior executive roles across global marketing and business development, pricing as well as project management and global operations functions. Ariette’s ability to lead global teams has built strong, strategic relationships with major Pharma and CRO companies. Her extensive work on the central lab and clinical side brings a unique perspective of the supply chain to her current role.