Logistics
One oncology patient who lived in Malaysia and usually travelled weekly to Singapore to take part in a clinical trial was no longer able to cross the border. In this case, clinical research organisation (CRO) Parexel worked with the Ministry of Health in Singapore and Malaysia to make a protocol deviation that allowed the nurse to visit the patient’s home in Malaysia, as well as shipping the drugs and ancillary materials from the Singapore depot straight to the patient’s home. “This was one of several such examples. In some cases, patients were 200–250km away from investigative sites and, as we were blind to where the patient was, we had to work closely with the site to make sure materials were shipped from the hospitals to the right addresses,” explains Sanjay Vyas, executive vice-president of Parexel India and head of clinical trial supplies and logistics. “If the IMP had arrived at the patients’ homes and the materials were not there to support the injection of the drugs, it would have been impossible.”
Ancillary supplies range from simple things like tubes, bottle caps, syringes, needles and pregnancy kits to custom on-body devices, pumps and centrifuges. Parexel alone has seven clinical distribution depots around the world stocking more than 3,000 different ancillary line items at any one time, and a single trial can require up to 35 of them. Perhaps due to the simplicity of many of these items, sponsors often give little thought to the potential complexity involved in sourcing them. “People often forget that these are actually the carriers of the IMP to the patient’s body, and sometimes you’ll end up with a requirement for an ancillary supply landing on your desk at the last moment. The sponsor will say, ‘We also need this for the study, we forgot to add it’,” Vyas explains.
Regulatory hurdles
Parexel complies with the same standard operating procedures (SOPs) for ancillary supplies as they do for IMPs, following good manufacturing practice (GMP), good distribution practice (GDP) and good tissue practice (GTP) processes. “Having the same standards as IMPs is critical. You can’t just put them on a rack somewhere,” Vyas stresses. “We cannot forget that the patient is at the end of the line.” Yet, regulations are harder to follow for ancillaries than they are for IMPs. “The sourcing of IMPs is easier and more structured because there are very clear regulations for it. Regulators are very clear about what an IMP is and where it can be sourced from. There’s always a clear chain of custody that has been defined. But that doesn’t happen with ancillaries. Sometimes you need to have scanned suppliers at several levels – sometimes at country level, sometimes at regional level and sometimes at a global level.”
Clinical Trials Insight /
www.worldpharmaceuticals.net
For this reason, it’s important for sponsors to have a cross-border compliance strategy. Say, for example, a sponsor has selected 28 sites and plans to recruit 3,000 patients over the next three years in Latin America, Eastern Europe, Russia or Asia. “They need to think about how they are going to get their materials to these sites,” Vyas says. “There are some complex countries in these regions, where cross- border compliances are terrible. Sometimes, some materials are allowed, some materials are not allowed. You have to think about proactively planning a global trade compliance strategy.”
Keeping trials running throughout the pandemic meant that IMPs and ancillary supplies needed to be shipped to patients’ homes.
“The sourcing of IMPs is easier and more structured because there are very clear regulations for it. Regulators are very clear about what an IMP is and where it can be sourced from.”
Sanjay Vyas
In addition, trials themselves are becoming more complicated, as biologics such as cell and gene therapies become more prevalent. “When you start looking at some of these new therapies, some of the new vaccination approaches that have come in, plus the complex requirements of moving these IMPs at a particular temperature, you also require ancillary materials that can support these trials,” says Vyas.
Quadruple complications
Add a global pandemic to an already challenging set of circumstances and, according to Vyas, the complexity of ancillary sourcing has “quadrupled” over the past two years. “Borders started shutting down. Planes were on the ground. Many governments started putting restrictions on the materials that
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