The Successful attaining the Recruitment Targets in Japan and 3H’s optimizing holistic approach for Challenging Clinical Trials.

When conducting clinical trials, it is important to have a well-constructed recruitment pathway. Clinical trials which fail to meet the enrolment target could have substantial delays as well as have small sample sizes which could decrease the study power and lead to early termination. As many as 85% of clinical trials fail to meet recruitment targets within the targeted timelines and this adds to the clinical trial conducting costs. Delay in recruitment leads to significant financial implications and nearly 10% of a clinical trial budget is dedicated for patient recruitment. Thus, 3H helps with quality potential lead generation which is important for recruitment. The human cost involved is high with trial budgets exceeding. To help with rapid set-up of a clinical trial, 3H assists with ethics and regulatory submissions as well as review of draft protocols to identify any complexities. It is important for a pharmaceutical company to align with the correct partner to help in avoiding any foreseen delays. 3H is a great choice as it has an vast patient database excellent record with feasibility assessments and proved recruitment campaign tactics to meet the timely recruitment

Why Recruitment is a Challenge in Clinical Trials: The reasons why clinical trials fail to recruit on time are due to several reasons. Some of the most common ones are:

• Participant Issues: Understanding the intensions of  subjects to participate in a clinical trial is important. It is also important to have a study site which has easy access to the participant. People across different socioeconomic strata can have different trust levels on participating in clinical trials. Regular awareness among the public about clinical trials can help change any negative perception. 3H helps in finding strategic sites to accommodate subjects across clinical trials. Further, 3H’s biweekly seminar (https://oncolo.jp/event/0825canow_1) on dedicated oncology indication wipes out many misconception and spread the awareness among potential participants as well.

Some of the successful recruitment strategies used by 3H includes:

• Seikatsu Kojo Web: This flagship website has the public being made aware of what clinical trials are. The registration process is simple and important details of subject medications, diseases and other data such as laboratory data is collected in the database. Thus, eligible subjects for protocols can be searched easily. Study information is uploaded on the website, email magazines and contact center. The individuals registered have a keen interest in clinical trials, so the rate of consenting is high.
• Patient Centric Advertising: 3H reaches the public though all modes of advertising ranging from Yahoo and Facebook advertising to conventional advertising such as newspapers, radio and television adds. Banners and posters too are used for displaying in pharmacies, clinics and community centres. Highly effective advertising is done, while confining to the ethics of GCP.
• Trial Branding for Smooth Trials: The 3H team takes great consideration to brand the protocol in action. The recruitment specialists identifies the precise patient profiles needed for the study. To attain patient centricity, a logo, copy and message is created. The tools strengthen the active support with an investigator and study coordinator in charge.
• Disease awareness campaigns: To actively seek subjects, 3H conducts disease awareness campaigns targeted to understand people with high risk and know their disease conditions better and how clinical trials can help, especially in the case of rare diseases.

3H helps with subject analysis to planning, tool creation, content creation and even provides contact centre facilities. This significantly reduces costs and manpower to sponsor to effectively speed recruitment, while reducing the number of screen failures as the most eligible subjects for the clinical trial is sought after.

To learn more about how we can support your study, kindly reach us at imran@3h-ms.co.jp