Study Rescue

Eighty percent of clinical trials are delayed. If that number doesn't scare you, it should. After all, if pharma can't roll out its research studies, then it can't produce tomorrow's drugs.

Kathleen Drennan, Iris Global Clinical Trial Solutions

Clinical trials often derail because of the failure to recruit qualified patients. Kathleen Drennan, head of Iris Global Clinical Trial Solutions, which specializes in patient recruitment, knows this well. "These 'rescue trials' come to us when companies have spent their budget, tried everything they could, and still, they can't fulfill patient enrollment," she says.

Instead, companies should quit wasting their time and get strategic when it comes to mapping out their study strategy. Here, Drennan sits down with Pharm Exec to explain how.

There are better drugs already on the market and fewer drug-naïve patients. But does that explain the massive delays in filling the industry's clinical trials?

One of the more overlooked problems is that companies still rely on the individual investigators to recruit and educate patients and conduct the trial. In the old days, doctors could draw on patients in their practice. But today there are fewer big practices, so they have to go outside their offices to find patients. For instance, one investigator could run 10 studies for atrial fibrillation in cardiovascular disease. He's not going to have all those patients in his own practice, so he has to recruit—which means working with the media and doing grassroots efforts in the community. And guess what? The majority of docs don't do such a hot job. That's why studies are delayed.

Of course, compounding the problem is the distrust of pharma. Patients confuse a lot of the issues, and largely because of drug prices, anything pharma companies sponsor they tend to be more distrustful of.

What is the industry doing about this?

Pharma hasn't really taken the gauntlet when it comes to clinical trials. Most people still think of it as testing on guinea pigs. Although patients can get information in newspapers or direct mail or on the Internet, they really get their information when something terrible happens and it hits the mass media. The industry doesn't do any type of major education initiative, so that's all patients know.

What action should companies take?

First, they must put something into clinical trials that's been left out—strategy.

Study sponsors typically begin clinical trials by writing the protocol, which is the study "cookbook" for doctors: You have to see this many patients, conduct this many visits, do this many lab tests, and so forth. But usually, study sponsors write the protocol in a hurry at the last minute, without doing any real market research or feasibility studies to understand whether the protocol with its inclusion and exclusion criteria is going to work in the real world. Clinical trial protocols are created more like how you would cook spaghetti—you throw it at the wall and see what sticks in terms of getting the trial done.

Instead, companies should have a road map to get those patients. Who are the right investigators? Are they in the same geographic area as patients? How will you communicate to patients to motivate them to join your study?

How do postmarketing studies compare?

I don't think the needs of postmarketing studies today have caught up with the resources that companies are willing to put into them. These studies are larger and cost more than before, and they require as much diligence as your premarketing studies.

So the industry has a lot to learn. What parts of the puzzle are they doing well?

We're doing a 10-year registry in children for a marketed dermatology drug, which was mandated by FDA. But a lot of companies are willing to more proactively conduct Phase IV studies. That's good, because if they show FDA that they're monitoring their drugs, then that might hold off FDA coming in and making even more requests of them.

Adaptive trials is another area that isn't yet in full force, but I know of companies that are building divisions for this. That's going to allow companies to bypass these long, interminable studies if something is clearly working well. They're going to be able to move it through the pipeline faster.

Can you pinpoint the inertia to change?

Money is being thrown down a big black hole simply because pharma companies are slow to change the way they have always done things. The future is better study strategies and tactical plans. It sounds simple, but nobody's doing it. To me, those are the vehicles that executives have to implement to create fewer studies that need to be rescued—and see that 80-percent-delay rate go down.