Critical Population Research

In addition to regulatory, data collection and safety elements, most clinical trial protocols define the elements needed to medically evaluate patients for inclusion and continued participation in a clinical trial. Content and direction as to the desirability of a patient is contained within every protocol, however, generally no content beyond age, sex and occasionally ethnicity is provided.

Critical Population Research (CPR) goes beyond standard protocol information and evaluates these and many more factors and creates an exacting roadmap for clinical trial enrollment success; factors involving geography, economics, patient’s proximity and access to healthcare, and the etiology and prevalence of the disease or illness under study. CPR defines what mediums (e.g., TV, Radio) persons within given communities receive information, and helps to pin-point the most effective “messages” needed to communicate to potential study candidates.

CPR provides practical enrollment targeting ensuring that patients cannot only be found, but can be gathered by an Investigator for screening, randomization and completion.

• Investigator Selection has a profound influence over enrollment success. While not always obvious, highly visible Investigators, even those practicing in well known medical environments may have the least access to day-to-day patients required for many clinical trials. Alternatively, Investigators practicing in a variety of community based (private-practice and hospitals) setting may have the best proximity to the patients needed.
• Availability of transportation within a given geographic area plays a significant role on Patient enrollment even within areas with significant disease/illness density. If a patient cannot conveniently travel to an Investigator, that patient will not become available for screening or recurring study visits. In large metropolitan areas like New York, Chicago or Los Angeles, most persons will travel only limited distances to purchase consumer goods or obtain healthcare. Conversely, persons living in more rural or suburban environments will travel greater distances for consumer goods or healthcare services.
• Selection and mix of direct-to-patient messaging (using media) is another critical element that CPR provides. Using highly predictable data, CPR will pinpoint the exact medium within a given budget and geographic area needed to attract additional patients (study candidates) into an Investigator/Site. This same data enables Sponsors to make quantitative decisions about Investigator placement (geographically) instead of relying upon self-reported retrospective surveys.
• Age, sex, ethnicity and economics are other deciding factors that play into the success of clinical trial enrollment. CPR isolates these elements into patterns and trends that enables Inclinix to precisely determine:
  • how to communicate... using mediums such as television, radio, internet, etc.
  • when to communicate... time periods throughout the day and night when best to communicate
  • what to say... optimizing the message about the benefit of a clinical trial in order to attract the highest number of respondents (study candidates)

CPR for “Special” Population Studies

Some protocols mandate a percentage composition of study candidates based upon racial, ethnic, or genotype variation. For these studies CPR is a highly effective means to define the following:

• the most appropriate locations where targeted patients can be found (by geography and type of healthcare delivery setting)
• the most appropriate type of Investigator who serves this community
• the best method to communicate the study message

CPR to Plan and Execute

Inclinix believes that a clinical trial protocol is not complete until CPR has been incorporated as an SOP.

• CPR can be applied as a Feasibility tool before a protocol is complete, before Investigators are selected, or before any methods of outreach (direct-to-patient communication) are developed.
• CPR can be applied as an Enrollment tool during the conduct of the clinical trial by applying real-time enrollment data converted into media selection and management information. CPR will optimize messaging to potential study candidates, placement of media (by type, location, and frequency) and generate predictable, measurable and cost-effective results.
• CPR ensures the right investigators, in the most appropriate locations, with the greatest proximity and access to targeted patients are available for your study …. CPR is your SOP for success.