Manna Research - How to mitigate risk in clinical trials

Feasibility studies are evolving: increasingly penetrating questions combined with online technology use are improving speed and accuracy. Yet, not all the changes are for the best. Dr Graham Wood, chief executive officer at Manna Research, explores the impact these new approaches are having on the sector.

Can you briefly introduce yourself as a company?

Dr Graham Wood: Manna Research owns and operates four clinical research sites across Canada that focus on Phase II-IV primary care studies. We have been performing clinical research trials since 1995 and have completed more than 550 studies to date. Located either within or next to large family practices, our sites have immediate access to over 350,000 patients.

We also recruit from the community and have more than 8.5 million people in our catchment area. Our ten principal investigators ensure the highest standard of care for our patients and the best quality data, giving our sponsors the information needed to support their regulatory submissions.

What makes feasibility such an important part of the clinical trials process?

The feasibility process is what kicks off every clinical research study. The sponsor or CRO managing the study reaches out to sites to gauge the number of recruitable patients and how quickly they can be obtained. Sponsors also enquire about staffing and equipment in order to make sure they match the study's needs.

In an attempt to mitigate the risk of working with a site that is ill equipped or unable to properly recruit, the feasibility process allows sponsors to filter potential sites and identify those most appropriate for a given study. From a site's perspective, conducting feasibilities allows us to better understand upcoming studies and to manage the pipeline going forward.

How has the feasibility process changed over the years?

The types of questions asked about resources have not changed much. However, those regarding recruitment ability have evolved from simply asking the sites directly how many patients they can recruit and how fast, to requesting details on how each inclusion and exclusion criterion will cut down the number of those eligible. As an example, the questionnaire will ask how many diabetics the site has on their database, then how many of those diabetics are on a certain dose of metformin, then what number of those patients have an Hb A1c between seven and ten, and so forth. These extra details mean feasibility questionnaires are now two or three times longer.

The technology used to distribute and complete the questionnaires has also changed; what used to be done by faxed forms filled out by hand is now performed using electronically completed emailed forms, or online.

What impact are the more detailed questions having on the process?

The details that are being asked of sites undoubtedly help the sponsor or CRO make their selection. However, completing a feasibility process that requests these types of details takes a lot longer. Furthermore, sometimes information such as clinical laboratory values requested cannot be accessed by sites. Some of the most sophisticated electronic medical records systems allow sites to quickly perform searches, such as those used across the Manna Research sites, but the details often go beyond what is contained in the records.

Is the introduction of new technologies helping to streamline the process?

When feasibilities moved from faxes to emailed electronic forms, sites and sponsors saw a huge benefit in the ability to input and manage information. Taking things one step further, many sponsors and CROs have developed or are currently creating databases that store previous responses. As a result, sites no longer need to answer questions about equipment and facilities again and again - they only respond when there is a change.

However, some systems actually make it harder for sites to complete feasibilities. With direct data input into organised databases through the back end of platforms, web-based forms certainly speed up the process for both sponsor and CRO. But certain web-based interfaces limit collaboration within the site. Some web-based tools force users to complete feasibilities in a single sitting, or don't allow questions to be viewed all at once.

At our sites, we get input from multiple doctors and coordinators for every feasibility. This type of collaboration helps us cover all bases in our responses and is something that should be encouraged. However, it becomes complicated when working with a number of the less flexible feasibility input platforms.

What impact are these sorts of inflexibilities having on the clinical trials sector?

The time a site has to complete feasibilities is finite. If more time is needed to work through technical issues, then there is the possibility that less time is devoted to researching the responses. With minimal work and a focus on user feedback, the systems now being used can help us make feasibilities as accurate as possible so recruiting targets can be met.

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