Outsourcing
Global central labs have systems worked out
When it comes to choosing a central laboratory, there are good logistical reasons, Bi points out, for selecting one near the patients being studied. He cites the eruption of the Eyjafjallajökull volcano in Iceland in 2010 as an example of an event that disrupted the ability to transport samples from different locations. Covid-19 is a more recent example of an unanticipated event that has, says Young, “impacted clinical development in multiple ways”. This has included difficulties moving samples between countries that have closed borders, such as New Zealand. “So, what does that mean in terms of sample accrual – samples going to central labs which may not be in New Zealand?” he asks. “There are clearly problems in just maintaining sample integrity,” he notes. “This is one of the reasons global central labs make so much sense, because they’ve got those systems worked out.” So, what are the key factors sponsors should consider when choosing a central lab? While there are some companies dedicated solely to providing central laboratory services, there are also a number of contract research organisations (CROs) that provide central lab services as part of their full- service model. One of the advantages of opting for a CRO is the ability to integrate data from different services. For example, says Bi, bioanalytical measurements are typically carried out in a separate laboratory and are, therefore, often not fully integrated with the central lab work. A full-service CRO is more likely to be able to offer that integration. Local CROs, such as ChemPartner and ClinChoice who are headquartered in the region, “do outstanding work at significantly lower cost”, says Young. Because these are “local to the Asia Pac ecosystem”, he adds, they are “quite familiar with the regulatory scenario that exists, for instance in China, which is somewhat different than other countries”.
Harmonisation is crucial
Several global CROs also offer central laboratory services in Asia-Pacific countries to sponsors carrying out clinical trials in the region. These include players such as Parexel, PPD and Bi’s own company, Labcorp. These companies have the advantage of size; larger laboratories, says Bi, will have the scale to support a number of different trials. “[Labcorp has] thousands of assays or methods available, but when you go to a smaller player, they may have 100 or 200 assays,” he adds. Similarly, the company’s staff has a wide range of scientific expertise.
As well as lacking a breadth of scientific expertise, smaller laboratories may not be able to
Clinical Trials Insight /
www.worldpharmaceuticals.net
scale to handle thousands of samples, argues Bi: “If you look at the latest oncology trials, a trial could cover ten or 15 indications with multiple legs. That represents tremendous complexity.” He points out that the lab will need to be able to analyse multiple sets of data: “If you don’t have the means to handle that, it will be a nightmare.” Young notes that much of the central lab work being done in countries outside the US and Western Europe “has coalesced from groups of independent clinics or smaller university, or hospital clinics”. Because central labs are “largely involved in making sure that all of your tissue samples and all of your data collection are collected and analysed in a uniform manner”, he says, the consistency and comparability of testing methods and equipment across labs is crucial. “Small variations in equipment and testing standards, concentration standards of reagents, can effectively mess up your work.”
“If you look at the latest oncology trials, a trial could cover ten or 15 indications with multiple legs. That represents tremendous complexity. If you don’t have the means to handle that, it will be a nightmare.”
Honggang Bi
In a global trial, therefore, harmonisation is crucial, Young adds. Sponsors will want to check whether the laboratory has accreditation from the College of American Pathologists or meets the requirements of the Centers for Disease Control and Prevention (CDC) or the National Glycohemoglobin Standardization Program (NGSP). The lab will also need to meet the local requirements of the ministries of health in the different countries.
Be aware of regulatory processes In cases where the sponsor is initiating a large global programme that might run for several years, says Young, it can be worth carrying out an audit or at least reviewing existing audits of the central labs involved. “You want that audit to not only address protocol and internal standards, but to take a look at financial stability and look at not only the technology but also the technicians that are involved,” he says. It should also ask questions such as: “Have there been any financial improprieties? Have there been concerns about any of the personnel or the leadership of that particular central lab?” Factors such as these “contribute to the operational norms, which are important to maintaining good relationships”.
$11.9bn The estimated
value of the contract research organisation market in 2025.
Beroe Analysis 35
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45
