The merits of a CRO (Clinical or Contract Research Organisation) with regards to subject retention and recruitment should be evaluated with at least similar attention and care as is given to a CRO’s ability to conduct a bridging study clinically and produce good quality viable data. When selecting a CRO or recruitment specialist to recruit specialist subject populations such as Japanese subjects, a sponsor will need to take into account various factors, including:
- Company structure and culture
- Safety record
- Track record
- Approaches to recruitment such as advertising, attraction and retention
- Safeguard against over-volunteering
Company Culture and Structure
The appropriate company culture and infrastructure is very important to both subjects and sponsors who are considering participating in a bridging study, especially for the first time. A good CRO understands this and is able to ensure that their staff is trained appropriately such that they can deal with various populations. Their staff should also be able to understand small but sometimes very important nuances that demonstrate that the CRO is able to successfully integrate within the target population. A company that is involved in conducting clinical trials that involve Japanese subjects can only be taken seriously if they place the appropriate amount of significance on bridging the cultural gap.
The clinical trial environment subjects are entering is naturally foreign to them, especially if this is the first trial they have made a decision to participate in. Such an environment can be even more daunting for Japanese subjects, and it is therefore imperative that the CRO ensures a cultural blend within its employees, which will enable it to meet its volunteer’s needs. This blend must be evident through the entire company, originating from the first point of contact (within the marketing branch) that a potential Japanese subject has with the CRO, through to its interaction with clinical staff and subject recruitment agents.
A good way of easing initial concerns that a Japanese subject may have about becoming involved in bridging studies (clinical research) is by ensuring that the company has a core group of well-trained professional Japanese employees. The presence of such employees in all facets of the company serves as extended infrastructure to the Japanese subjects and helps to cement the bond of trust that is necessary for success in specialist research.
When searching for a good indicator of how well a CRO has performed in appropriately integrating itself within the target recruitment population, you don’t have to look any further than their repeat rate of Japanese trial participants, along with the extent to which previous trial participants recommend friends and colleagues to participate in a trial with a CRO. This is easier to achieve with an inbuilt Japanese infrastructure within the CRO, as it serves as a demonstration to existing and potential Japanese clinical trial participants of the importance of these subjects to new drug development within the Japanese population demographic. Moreover, such an inbuilt culture and infrastructure, when combined with the trust that must be worked on continuously, routinely translates into a CRO on which sponsors can confidently depend.
One such Clinical Research Organisation based in the United Kingdom is Richmond Pharmacology who has conducted over 50 successful bridging studies on Japanese and Caucasian subjects. If you would like to learn more about bridging studies, please visit www.bridgingstudies.com