Many of the delays seen in trials these days originate in the start-up phase. The parties agree to get moving, and then a protocol is untenable, or the investigators can’t find as many patients as expected, or regulatory snafus appear. Chaos ensues.

Feasibility studies can be a way to circumvent all that, asserts Javier Revuelta, MDS Pharma Services’ head of clinical operations for Europe and Asia. As more sponsors are taking their trials global, feasibility studies are becoming more common.

Dedicated Unit

MDS has a unit dedicated to the start-up phase of its clients’ studies—and half of that unit’s resources go toward feasibility studies.

What exactly is a feasibility study? A detailed survey, usually of the study sites, “to assess and define how the study will be managed, and whether it is something that can be managed,” said Revuelta. Sometimes the focus is on exactly how many patients an investigator has access to. Other times, the regulatory time line is carefully assessed. Still other times the focus is more clinical. It all depends on what the sponsor is asking for, what it needs to know.

CRAs and Surveys

The information is often gathered by clinical research assistants (CRAs) on the ground near the site. Also used are questionnaires that investigators fill in. Then there’s a teleconference to help tie it all together, said Revuelta. The end result should be a carefully thought-out and realistic assessment of what can be done at a certain site, or in a certain country—with “realistic” being the key word.

Revuelta said some CROs that do feasibility studies can have a tendency to paint a rosy picture about what’s possible in order to keep the client happy, or to look good themselves as they jockey to show a potential new client what they’re capable of.

Rosy vs. Realistic

But in the end, he said, that’s a bad idea. The sponsor can end up angry if projected numbers don’t jibe with reality. Depending on the contract, a CRO can end up losing money.

“More and more, we are exposed to some risk as a CRO because we sometimes sign fixed budgets, so you need to be very accurate in your predictions,” said Revuelta. In other words, the CRO often gets a fixed sum for conducting the study. If the pace of finding patients has been exaggerated, the CRO may have to absorb the cost of any delay.

Contract Structures

Feasibility studies can take a variety of forms. They are sometimes part of the overall contract between a CRO and a sponsor on a particular study. Or they can be part of the proposal process. Or sometimes a sponsor will pay a CRO just for the feasibility study, see what is produced then decide whether to proceed with that study and CRO. Feasibility studies can also be done after a study is under way “to assess changes needed to the study or just assess contingency plans,” said Revuelta.

For global studies, just about everyone’s doing feasibility studies, he added. “They need help deciding which country is better to go to: Belarus or Armenia?”

Managing Expectations

Also, for Phase III studies, most sponsors want feasibility studies run before they dive in. Revuelta added that for Phase I and II, many sponsors will run feasibility studies themselves, especially when they’ve been working on a particular compound and have good relationships with specific investigators.

One newly troubling trend, however, is the three-day feasibility study. Some sponsors have begun to expect that level of speed. But Revuelta argues that three days is not enough time to garner a realistic picture.

Slow Acceleration

During a session on study start up at the 2008 annual DIA meeting in Boston, he sounded a skeptical note. Said Revuelta: “Running a global feasibility study in three days ... you cannot release the name of the study drug, you don’t have even a synopsis, you have a title but this is not a final title, not to mention that the fees for investigators are not even considered—but you need to predict exactly the number of patients? Also the time lines for ethics committees, in three days? You can get data but you don’t get real information. And you can upset investigators at a time when you really need their cooperation.”

In general, MDS tells clients it will take closer to two weeks, depending on the depth of information that needs to be gathered. But it can take longer to do the job right. It is not unheard of for sponsors to add new elements to the project toward the end of a feasibility study—different admission criteria, for instance—that may force the CRO to go back to the drawing board.

Revuelta of MDS Pharma

But things do move faster, Revuelta said. Ten years ago, there was more faxing going on, as opposed to e-mailing. Other data can be gathered electronically instead of on paper. Plus design of the questionnaires is better. It all adds up to a quicker process.

Revuelta says that sponsors seem to be getting the concept and why it makes sense. “What I see is more and more understanding from clients of what a feasibility study is and what they can expect to get from it,” he says.

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