Global Clinical Trials Regulatory and Operational Insurance Risk Map

Dec 9, 2019 | Aon, Globalization, Insurance, Regulations, Study Start Up

Global Clinical Trials Regulatory and Operational Insurance Risk Map

For most industry sponsors, conducting clinical trials represents a multi-national, global affair. With rapid drug market globalization, comes the need for more global clinical trials. As we are map geeks here at TrialSite News, we share, for those interested, the significantly dry yet incredibly important subject of clinical trials global insurance. A plethora of regulatory and operational challenges follow the global pursuits of clinical programs driven by industry, government and non-profit clinical trials sponsors. Visualizing the global risk, at a high level, intrigues those that care about these sorts of things. Aon’s 6th edition Clinical Trials Risk Map highlights clinical trials insurance regulations and complexities for over 80 countries throughout the world.

Aon (NYSE: AON), a result of years of mergers, acquisitions and related activity, is a global insurance giant based in London, UK. With about 50,000 employees, the firm generates $10+ billion turnover. Competitors include AIG, Marsh & McLennan, Mercer, Gallagher and Allianz.

Clinical Trials and Global Risk

Aon Life Sciences group possess a considerable global network and clinical trials expertise. Their global network supports global biopharmaceutical companies to efficiently and effectively secure international clinical trial coverage that complies with each and every regulatory requirement of individual countries. The goal—allow drug developers to minimize risk of financial volatility—vital in working to keep drug development costs under control. Often, clinical trials must secure proof of insurance prior to study start up.

The Sixth Edition Life Sciences Clinical Trials Risk Map

The Sixth Edition of Aon’s Life Sciences Clinical Trials Risk Map emphasizes the accelerated globalization now ongoing in the clinical trials industry.  Key updates include the focus outside of the U.S. for conduct of clinical trials, so that sponsors can advance their investigational products through the regulatory approval process to meet study start up milestones. Each nation has its own clinical trials liability insurance requirements and trial sponsors must understand, and meet these requirements to effectively and efficiently conduct commercial trials. What can be a labyrinth maze of regulatory and bureaucratic red tape ensures sponsors must often secure a certificate of insurance with specific requirements, on a country by country basis, for regulatory filings prior to clinical trial approval.

Issues to Consider

Life Science sponsors face considerable risks for securing insurance for foreign trials: time and cost can rapidly increase if not managed carefully. There are not a lot of insurance companies that can cover industry-focused liability exposure (e.g. pediatric populations, vaccines, biologics)—in fact in actuality there are few firms that can offer comprehensive coverage across the world’s nations when it comes to comprehensive clinical trials in specialized therapeutic areas with significant risk. And issues associated with complexity and administrative and legal procedure can entangle even the most sophisticated of operations. Country by country, elements further offer consideration for underwriting coverage for specific clinical trials. Specific insurance companies may impose indication-level constraints on coverage as well. National laws must be factored in, understood and incorporated into the global strategy. Other constraints abound—for example, most companies insurers can’t just issue policies in certain countries at all—hence, they rely on a network of “affiliated” partners and thereby secure coverage via joint agreements or separate agreements in certain countries with alternative insurance companies. Moreover, the sponsor must often offer evidence of coverage, which by itself can introduce more complexities. For example, local IRBs (called Ethics Committees in some parts of the world) often must receive evidence of coverage and hence demand amendments in order to progress with study start up. Imagine the pressure sponsors face to meet site activation and study start up timelines: if there are insurance issues, the IRB/EC may require additional underwriting changes, which could lead to delays and more cost. It is a complicated business.

AON Life Science Practice

AON offers a range of services for life science companies—from upstarts seeking to expand outside of America to well-established multinationals managing large volumes of international clinical trial certificates coordinated via multiple centers worldwide. Firms such as Aon offer managed services for activities such as controlled master programs arranged with insurers capable of issuing certificates in most countries worldwide—those using insured fronted and captive programs to localized efforts where in-country placements are needed or for collaboration and coordination with local client trial managers and CROs. Aon and undoubtedly its competitors will offer a proprietary database of global clinical trials regulations available via a secure online portal.

Source: Aon

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