The COVID-19 has thrown the clinical research industry for a loop. With flights grounded, businesses shuttered, and participants afraid to leave their homes, continuing trials has been made exceedingly difficult.
For sites and sponsors seeking to continue the pursuit of tests, treatments and other vital products, finding a way to keep trials going is critical. With such incredible, widespread interruptions striking the supply chain, logistics companies like Marken (a UPS company) are working to come up with solutions that keep trial treatments and supplies getting to where they need to be.
Outsourcing-Pharma (OSP) talked to Ariette Van Strien (AVS), president of Marken, and Kimberly Finn (KF), Marken’s vice president of Global Patient Centric Services, about the unparalleled interruptions to the global trial supply chain, and how such obstacles can be mitigated.
OSP: How are Marken's services making an impact on the clinical trial supply chain in light of the pandemic?
AVS: With the current COVID-19 crisis, the biggest challenge the industry is facing is how to keep clinical trials running. To accomplish this we need to get clinical drug products into countries, and get biological samples out of countries, and then back to the major central labs. We have been using many alternative solutions to make this happen amid a constant evolving landscape. Every day, there's another country imposing new restrictions. Commercial airlines have been reducing flights up to 95%. For us, being a UPS company gives us an incredible advantage, where we can leverage the UPS global network, and use our Marken setup in each country for the first and final mile.
I think that we will see several pharmaceutical companies considering if they should put any patient recruitment on hold. One of the reasons for this consideration is to reallocate the time of physicians and other healthcare providers to focus on COVID-19 patients.
Clients have asked us how they can benefit from direct-to-patient (DTP) services — ensuring the drugs go directly to the patient's home, versus having the patient go to the clinic. That has been our focus now, since early January. It’s a service we’ve offered since 2013, but we have been asked to expand DTP deliveries to several more countries. We were active in 57 countries. Now we're looking to expand it to 72 countries in order to keep patients enrolled in their clinical trials, so they can stay in and complete these studies.
China, Korea, Italy, the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have all launched new guidelines on how clinical trials can be conducted, with variations allowing the possibility to deliver clinical products to the patient's home.
Kim: Direct to/from patient (DTP/DFP) has certainly been the growing focus over the past several months. But now, more clients are utilizing DTP services so that critical medications can reach their patients, and we're now also experiencing an increase in requests for home healthcare (HHC) services. We currently have coverage for 50 countries and are seeing more requests from our clients to operationalize HHC and conduct either some or all of the traditional brick-and-mortar assessment in the patient's home. Clients are either requesting a full visit to be conducted in the home, or the critically necessary functions such as sample collection or IP administration.
Marken has built our HHC services over the past two years with a robust qualification process with each of our contracted agencies and providers.
OSP: Can you compare interruptions in the supply chain that we are experiencing with COVID-19 to other epidemics or events, like Ebola or Zika?
AVS: Marken was asked to provide supply solutions in South Korea for MERS when it happened in 2015. Patients who needed clinical trial drugs could no longer safely access health centers without exposure to MERS. Pharma companies and CROs could apply to the Korea Ministry of Food and Drug Safety to allow for DTP shipments.
We always look and find alternative solutions to meet the client and patient needs in each impacted country. We have booked charter flights when other options are not available. Just recently, with limited time to maintain lab sample viability and no cargo flight options available, Marken chartered a private plane to transport biological samples from clinical trial patients to testing facilities outside an impacted country.
In another recent example, we were asked to deliver urgently required temperature-controlled clinical medication to several hospitals in Serbia. All commercial international traffic had been halted and limited cargo flights were booked, so through the collaborative efforts of Marken's team members, we chartered a Cessna. The outcome was that hospitals and patients received their critical drug supply within the necessary time and temperature requirements.
We continue to source global alternative options including UPS and local commercial carriers in/out of impacted countries around the world. Ground transportation alternatives will be utilized where and when flights are not possible.
Ebola didn't impact Europe or the U.S. This pandemic presents the first challenge to this extent with this level of global disruption of the clinical trial supply chain.
OSP: What plans are in place to help further bolster preparedness and your global network to help clinical trials deal with the issues?
AVS: Our clients worldwide are setting up the DTP deliveries, and we are encouraging all of our clients to plan long term, for even after the pandemic has passed. For instance, we suggest that our clients should consider adding DTP to protocols during trial set up so that you are ready to respond as needed. We continue to train our local service providers (LSPs) in every country in which we have DTP requests. Marken teams are trained in all European countries, Asia, US and Latin America to provide DTP solutions where needed. They are equipped with all of the necessary SOP training to comply with all safety regulations in each country in which they operate.
Our access to, and increased use of, single-use packaging solutions has become critical in areas where it's not feasible or safe to return boxes.
KF: This has absolutely changed the landscape of clinical trials. Virtual and hybrid trials are really a necessity now rather than an option. Sponsors are now willing to adopt this technology and this is really going to pave the way to move into that paradigm quite quickly. I don't know that we'll go back to traditionally-designed clinical trials after this pandemic.
We’ve developed the processes in order really to contain infectious disease control, and to minimize driver interaction with the patient. Marken has instituted a no touch policy in order to reduce the spread of COVID-19 to patients and drivers. Signatures from shippers for pickup on board and consignees for proof of delivery are not required. The driver will record the shipper’s and consignee’s details on the Marken booking form after verbal confirmation of each to document chain of custody.
For DTP deliveries, the driver will take a picture of the fully executed booking form and email to the respective Marken branch following the visit to confirm delivery, which drivers will be instructed to delete from their phone to maintain patient privacy. The completed booking forms will be provided to the sites for record. Our drivers are making it happen to ensure clinical trials move forward and our client's needs are met during this critical time. These patient-centric heroes, and all 1,200 Marken staff members, have continued to work around the clock and deliver supplies and clinical drug products to our clients and patients. The processes that we have now are solid with contingency plans in place, and we'll be able to apply it to any type of future pandemic or situation that may arise.
OSP: Why hasn’t adoption of decentralized trial technology been more widespread and rapid than it has been?
AVS: More pharma companies had been looking at decentralized models but quality is always at the forefront of the focus. Previous options included site oversight utilizing a hybrid trial versus a completely virtual trial. In a hybrid trial, some visits take place at the patient's home, and some can occur at the clinic. Pharma companies and smaller biotechs adopted it less quickly, but over the last few years, they too are switching to decentralized models. Moving away from a model which has been working for the last probably 25 years, and moving to a new model takes time.
KF: The industry rightfully wanted to ensure that proper oversight was in place, and to ensure the safety of the patient. Many companies are developing virtual trial technology, but integrating that technology along with existing clinical trial technology to create continual data analysis takes transition time. Additionally, local laws and regulations needed to be considered in light of how medical professionals engage with patients.
Countries can vary with requirements regarding how medical professionals can treat patients. All of the country-specific health regulations need to be evaluated and considered as you move into a fully virtual trial.
OSP: What can sites, sponsors, and admins do right now to help make their situation better in terms of minimizing the negative impact on the supply chain as it affects their businesses?
AVS: To help our clients evaluate the decisions on a country-by-country basis as to where they wish to put trials on hold or consider a DTP option, we created a Daily Critical Supply Chain update that’s emailed to 10,000 clients and summarizes by country what conditions may impact their trial decisions.
Our team members also reach out daily to many of our clients, in order to make sure that they understand what options they have in each country. It’s important to maintain constant contact with your logistics experts, and verify current statuses before making decisions, because things are evolving daily.
We have seen some incorrect information provided by other providers, or an incorrect interpretation of what information has been provided by health ministries in each country, so it's critical to verify with your local teams any information you receive. As long as the crisis is ongoing, and considering the new guidelines recently published, it's likely that most countries worldwide would potentially allow a switch to a decentralized model, a move to home deliveries and, where possible, home treatment until the situations in each country can return to normal.
KF: We do encourage our clients to think about the longer term as well. What's next after this? Right now, we're managing day by day, if not hour by hour, implementing all of the immediate contingencies and solutions needed. But things are changing rapidly, and no one knows how long this pandemic will impact clinical trials. We are focusing on longer term solutions too, not just for the next 1 to 2 or 3 months, but possibly even throughout 2020. We are ready to help provide solutions for trials everywhere, whether it be clinics, sites and hospitals, or fully virtual.