Forget Selecting a Site — Now the Site Selects You - Pharmaceutical Executive

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Forget Selecting a Site — Now the Site Selects You
The competition for where to conduct Phase IV trials is rewriting the rules of site selection


Pharmaceutical Executive


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.

Custom Value 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.


Killer Apps
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,"]


Value Add
Giving Back 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,]


Up, Up, and Away
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:
  • 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.


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