Global Clinical Trials: What To Consider

So, your pharma company has decided to enter into global clinical trials.

Congratulations!  Global trials can expand both subject recruitment and product commercialization opportunities.  This is most important in therapeutic areas where subject recruitment is domestically competitive.  This can be due to a high number of competing trials and/or a small subject population (e.g. a rare disease).

However, going global also increases trial complexity and cost.  This complexity obviously increases based on the number of additional countries involved.  However, it can also increase if countries are chosen where the health authority has intricate requirements or there are communication barriers (e.g. China in relation to the US).

Here’s a high-level summary of considerations for sponsors before they embark on global trials:

• Number of Countries
  • Sponsors should use the least number of countries as possible to meet the trial’s goals.
    • For each country added, sponsors must plan for and coordinate the factors listed below, all of which consumes time, effort, and money.
  • Further, sponsors should consider country variations in subject population and enrollment rate when creating the overall study plan.
• Health Authority and Ethics Regulations
  • Each country has different regulatory requirements and pathway.  Sponsors must thoroughly understand these requirements to gain timely approvals.
    • For example, in the US, sponsors generally need only seek approval from the country Health Authority (FDA) and then each site’s IRB, while in France, sponsors may need to also seek approval from  a Central Ethics Committee (CPP).
  • Health Authorities and Ethics Committees regulations may also govern other trial activities, e.g. clinical trial insurance and advertising used to recruit subjects.
• Data Privacy Regulations
  • Each country and state/region also has varying data privacy rules
    • For example, GDPR and CCPA, the requirement to house data in the originating country, the requirement to have a local representative or Data Privacy Officer (DPO).
• Drug Supply Chain
  • Sponsors may need to set up multiple sub-depots to ensure that drug reaches sites in a timely manner.
    • For example, if a trial uses Australian and Asian sites, a depot may need to be set up in Singapore.
  • Sponsors must also ensure that the appropriate import/export licenses are in place to allow drug to be transported from one country to another.
• Kit and Equipment Supply Chain
  • For the same reason as cited above, global sub-depots may also need to be set up to house vendor supplies (e.g. ECG supplies, wearables, or lab kits).
  • Sponsors must also ensure that the appropriate import/export licenses are in place to allow these materials to be transported from one country to another.
• CRO Capabilities
  • Sponsors must select a CRO or a combination of CROs that have experience operating in the countries chosen.
    • Obviously, having more than one CRO increase trial complexity.
  • If the CRO is being used for monitoring, sponsors must ensure that the CRO can provide local CRAs for each country.  CRAs should also be able to navigate the local language and business customs where necessary.
  • If the CRO is being considered for regulatory affairs, sponsors must ensure that the CRO is experienced in filing in each chosen country.
• Vendor Capabilities
  • Sponsors must ensure that vendors are able to communicate with and ship supplies to global sites.
• Investigator Meetings
  • Typically, for global trials, sponsors hold multiple, region-specific investigator meetings to minimize site staff travel and keep meetings focused.
• Sponsor Clinical Operations Team Size
  • Bigger and more complex trials may require more clinical sponsor staff – even if using a CRO.  (An exception is if the sponsor uses a technology platform like ClinOps Pro to automate work).
    • For example, a study may require multiple clinical trial managers, each managing one region each (e.g. North America, LATAM, APAC) in partnership with the CRO.
  • Sponsor clinical trial managers must oversee the CRO and also act as the CRO’s point-of-contact for trials escalations (e.g. approvals for site selection, subject recruitment advertising, and

    site budgets).

As with any important endeavor,  may your global trial journey be equal parts reward and challenge.

Our innovative Clinical Operations Oversight Solution, ClinOps Pro, supports clinical operations teams managing complex, global trials across all therapeutic areas.