Also helpful is providing workflows that show the site how the study can be incorporated into their practice or hospital without
disruption. Usually three or four sample workflows will accommodate the vast majority of practice situations. These workflows
can be immensely valuable in convincing a site to participate. Here's a real world example: In a post-approval study of cervical
cancer detection, a major medical device company devised a simple one-page data abstraction form to collect key information.
A web-based data collection and reporting system, which required less than 10 minutes training at most sites, was utilized.
Critically, the system was demonstrated to the sites as part of the recruitment effort so administrators could see for themselves
how easy it really was to participate. In a little over three weeks, more than 650 administrators were identified, enrolled,
fully trained, and had entered their first patient.
When it comes to the benefits that can be derived from participating in a particular study, the sky's the limit. The key is
zeroing in on the needs of the site. For example, orthopedic surgeons have different needs than cardiologists, and hospitals
have different value drivers than office practices.
Tactics to implement this strategy range from patient management tools to practice or hospital management tools. For example,
providing an automated means to communicate with referring doctors provides the office practice with both better patient care
and a practice-building opportunity. Providing benchmarking to hospitals can be used for quality improvement, negotiating
with third party payors, or to meet an accreditation requirement. [See "Killer Apps,"]
One of the reasons investigators participate in post-approval studies is for the sense of giving something back to the medical
community. For those for whom research is an avocation, participation in an important study or registry can be a source of
pride. The most successful programs are ones that become brands in and of themselves. Genentech's National Registry of Myocardial
Infarction or the American Heart Association's Get With the Guidelines are examples of programs that have achieved brand status
through numerous abstracts, publications, and citations. It's worth keeping in mind that the reason the Phase IV investigator
gives up a weekend to attend a meeting is not for the sun or the golf, but for the intellectual community around an area of
interest and the ability to learn more about the study's findings. [See "Value Add,]
Devil in the Details
Ultimately, convincing sites to participate in post-approval studies will depend on a sponsor's track record. With that in
mind, don't forget the following:
Up, Up, and Away
- Pay the sites accurately and on time. While money is not the primary motivator, payment disputes lead to frustration and anger.
Online payment reports for the site and sponsor may be one way to avoid confusion or problems.
- The help desk is the site's primary ambassador; a good relationship will make recruitment for the next study much easier.
Make sure your study help desk is knowledgeable, courteous and responsive.
- Remember, it's the site's data. They may want to use it to better or inform their practice, so making it inaccessible without
good reason is not well received in post-approval studies. Putting boundaries on specific data elements or releasing information
prior to a group publication is expected. However, unlike with pre-approval studies, making data more accessible will become
the post-approval norm.
- Implement easy-to-use technology and make sure it is focused on the needs of post-approval studies. It should be flexible
(it should allow users to work in a variety of ways, such as Web and voice) and should enable the sponsor to build a community
of research-naļ investigators across multiple integrated programs. It should also provide tools that enable sites to access
and even manipulate localized data. The system will also need to be inter-operable with other practice or hospital information
systems to decrease redundant data capture.