Clinical Trials: What Does Global Mean to You?

Speakers:Michael O’Brien, President & CEO, BEARDSWORTH

Art Gertel, VP, Strategic Regulatory Consulting, Medical Writing and QA, BEARDSWORTH

Navaneetha Rao, MS, ScD, Vice President, Clinical Research and Development, VICUS THERAPEUTICS

Renée E. Moore, President Global Operations, PROGENITOR INTERNATIONAL RESEARCH

What do we mean by globalization?

Definitions:

Regional – Localized to a distinct geography

International – multiple geographies

Global – The above plus employees in all major geographic areas in which clinical studies are being conducted.

Navaneeth Rao believed that many of the service providers are still mainly focused on execution aspect, because that’s how the CRO industry works. Many are not adapted to integrate the aspects he presents. The Service Provider looks at contextual localization. Renee Moore thought that geographical presence is a key primary concern where the study is projects. Being able to project an education strategy with the sponsor can provide this experience. Michael O’Brien thought that the drivers to globalization were lower cost basis, compress enrollment period, for marketing reasons. Very important for smaller CRO to represent where the price advantages are. It’s about value, not cost.

Partnership in a global environment. How do you best integrate the service of the sponsor? Can we maintain a partnerships moving on with the current clinical project? How do we maintain the integrity of the organism? What should sponsor considerations be? What does the staff retention look like? Loyalty, cost differential mythology, and locus of control. Renee Moore believed that the primary concern of the sponsor. Staff retention in an emerging market, the problem of increasing salary may arise. Staff retention is critical, and how do they maintain this over the period of the process. Is it appropriate to outsource outside your country? Outside your firm? Not every situation has the same solution, you must think outside the box.

Sponsor Trends – What are the trends? The advent of the outsourcing gate keeper, preferred provider, niche providers, effects of consolidation, effects of downsizing and local versus out of country. Clintrials.gov, the majority of clinical trials are ongoing in the US and Europe. The increasing competition and decreasing willingness of countries presents an overwhelming need to develop a global approach to clinical trials.

Contractual and financial consideration – Everyone structures their templates in different ways. Not all are changed. Michael O’Brien stated that there is a type of misalignment in a CRO with a sponsor. The sponsor is looking for the value of what they’re buying. It may be that the lack of clarity around the transfer of obligation to the CRO is partially the problem. CROs may take more risk in this relationship. Is the push to globalization enough of a step outside of the box to allow the relocation to the CRO. Renee Moore believed that the type of contract, service providers can and will enter into with a sponsor, driven by multiple factors. Smaller companies will have a little bit more of a challenge from a profit sharing model. Smaller may not be able to enter in to the contract without a neutral cash flow from the CROs. A built in risk when you’re working in global economies. An Example: 1.6 euros to 1.1 euros per 1 pound over six month period. Similar currencies are happening to all around the world. It is passed on to the current word. Putting in invoice that euro will be valued at what it is on the day of the contract.

Updated:

Here is an interview with Michael O'Brien and a small clip from this panel discussion: