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“When it comes to dedication, ICTS is second to none. Our study was in crisis mode. Everything we tried had failed. ICTS developed a novel approach to physician referral that prevented yet another round of adding investigators.”
Project Director, Top 50 Pharmaceutical Company

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Orphan Drug Studies and Difficult Patient Populations

  • November 07 2014

Risk AND Reward

The purpose of any recruitment strategy is to accelerate patient randomization by providing efficient solutions. As the industry leader in innovative patient enrollment tactics ICTS is constantly developing new and more efficient strategies. Many of the innovations that we developed were designed to meet the specific needs of difficult protocols and are now considered industry standards.

Social media has now reached an effective saturation point as a cultural medium and is beginning to replace national, charitable foundations as the primary resource for patient and caregiver advocacy and support. The socially interactive nature of sites like Facebook, twitter and others have made possible the rapid increase in personal healthcare discussions and the formation of many grassroots, indication-specific, interactive groups and personal experience blogs.

With the amount of time, effort and chatter being devoted to social media and patient recruitment, it would appear that someone has discovered a utopian strategy to fill all the needs of every clinical trial. While it's true that social media can be an effective tool, IRB restrictions on page content and visitor interaction have reduced clinical trial social media pages to nothing more than extended information advertising. As a result of these restrictions the patient enrollment community has effectively taken the “social” out of social media.

Using social media keyword and key phrase search advertising to bolster the social media aspect of a study website has become commonplace as a cost-efficient means of reaching potential patients for most average to high prevalence rate indications. ICTS was one of the first companies to utilize social media both organically and as an advertising resource and, we continue to utilize social media as a portion of enrollment strategies for many protocols. 

However, the specific challenges inherent in clinical trial enrollment for indications with very small, often orphan, populations make most currently acceptable enrollment strategies inefficient in both time and cost. In these types of studies the prevalence of academic medical centers as investigator sites, further complicates the enrollment process due to internal HIPAA guidelines and local IRB's. Standard patient recruitment strategies often prove to be costly which can drive a study team to maintain status quo rather than engage in an active patient enrollment plan.

Any communication for the specific purpose of developing inquiries for a clinical trial or clinical research site is regulated by both common rule and IRB guidelines. In most cases, getting communication pieces approved by a local IRB can be a long process. To expedite the development timeline of any recruitment effort involving high percentage of academic medical centers as investigator sites, a new paradigm for patient enrollment philosophy must be explored.

What if it was possible to develop a viable resource for clinical enrollment for studies that are small in scope and rely heavily upon key opinion leaders and academic medical centers?

If it were possible to utilize social media to engage potential patients and caregivers in healthcare discussions, while maintaining a conservative respect for IRB guidelines, what kind of structure would it have?

Is there a way we can engage patients and caregivers in active discussions of indication specific healthcare issues, attitudes towards clinical research, and lifestyle and qualifying information that can be used as a patient recruitment tool?

At ICTS, we have been conducting indication specific focus groups as a resource for engaging patient discussion and providing consumer-based healthcare information research for many years. Recently we began conducting focus group recruitment and research online via Facebook, reducing both time and cost and process. It is this blend of our experience with focus group research and social media that led to the development of our most recent innovative patient enrollment tactic.

The on-line focus group was only a step in the evolution of our new tool. We now have the means to rapidly accelerate the enrollment process for even the most difficult and smallest of protocols. And we can do this in a phenomenally cost effective manner.

Any new tactic comes with a certain amount of risk attached. The key is to mitigate risk by assessing common sense values inherent in the tactical design. We build along the common thread between currently acceptable tactics and the innovation. This is the practice employed by ICTS in the development of all new tools and we have never failed to deliver results. A little risk, especially in a tactic with a far lower cost than status quo, can go a long way to delivering a great reward.

For more information about this ICTS innovation, please contact Michael Ohrwashel, VP of business development via email or phone.