Key Issues in Clinical Development for Interventional CV Devices | Page 4

Key Issue #2: Site Selection »

Fortunately, manufacturers of interventional CV devices are accustomed

Selecting the right investigators may be the single most important

to providing proctoring services to physicians both during clinical

factor for trial success. Even the most insightful strategy and well-

trials and after device approval. Finally, the short technology cycles

designed protocol are useless if the data is not collected (or is not

for interventional CV devices can cause fierce competition for patients.

collected properly). Thorough data mining of past trial performance

Speed to market is imperative, as most of these devices are single-use

and a rigorous qualification process are essential steps in identifying

items (meaning that if they work properly, the patient may not

the best investigators.

need a replacement device for some time, if ever). As a result, it’s
vital to identify investigators who are committed to finding the best

Use information from past trials to pinpoint the right questions to ask,

solution for an individual patient, which may involve breaking down

which may include:

historical barriers between CV sub-specialties and challenging

• How many procedures have you performed with devices

existing treatment paradigms.

like the one under study (eg, artificial valves, stents,

Figure 3. Finding the Right Investigators

heart failure assist devices)?
• How many of your current patients would be eligible
for this trial?
• How long does it take you to get approval for trials (from
institution, ethics committee, government body [eg, the
Centers for Medicare and Medicaid Services in the US], etc.)?
• Are you willing to consider using a device in a patient you
would typically manage with medication (eg, someone with
heart failure)?
For interventional CV devices, site selection is complicated by the
small number of physicians with appropriate qualifications for the
type of device under study. For example, involving the world’s best
valve replacement surgeon can be extremely valuable if you are
developing an artificial valve but considerably less helpful if your
device is a drug-eluting stent. Physician expertise is a factor in
device outcomes,3 and novel devices may require significant
training for even the most experienced physician.

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