52 Perspectives: “Accelerating Patient Enrollment for Clinical Trials”

Partnerships In Clinical Trials 2011 Media Partner goBalto has teamed up with this blog to bring you weekly perspectives on the clinical trials and outsourcing industry. We are very excited to present you with weekly contributions leading up to next year's event!

52 Perspectives: “Accelerating Patient Enrollment for Clinical Trials”

Jae Chung

This week’s contribution to ’52 Perspectives’ comes to us from Vatche Bartekian, the President of Vantage BioTrials Inc. Vatche founded Vantage BioTrials Inc in April, 2007. Prior to taking on this new venture, he was an independent clinical research consultant working mostly for big pharma. He has been involved in the pharmaceutical industry for over 10 years and has gained broad experience handling complicated clinical trials across a vast array of therapeutic areas, specializing in clinical operations, project management and clinical monitoring.

1. What are some steps your company takes to make the clinical trial process go smoothly and successfully?

At Vantage BioTrials, our experience has shown that the best way to ensure a smooth and relatively successful process along our clinical trial management activities is by first developing a clear plan of communication between ourselves and the Sponsor.

Our Communication Plans are put into drafting as soon as the service contract has been signed. They are further finalized once Project Kick-off Meetings are held and logistics are agreed upon for the management of the study. The key players (i.e. decision makers) for the study are identified early, and we do our best to never change the team throughout the life of the project, unless otherwise requested by our Sponsor. This type of team continuity plays another important role in the success of the study. This is also why we work very diligently to maximize employee retention and minimize turnover at the project level.

Finally, we ensure that tools are set in place to aid the tracking of progress for the project and these tools are kept as simple and user-friendly as possible. Redundancy and duplication of efforts or information is usually a major factor in unnecessary delays throughout the lifecycle of a project, and our metrics tools have greatly helped in minimizing these delays.

2. What range of service and product offerings does your company have to ensure quick patient enrollment and reliable data?

Depending on the type of project (phase I through phase IV), we use a multitude of patient enrollment tools and services:

a) We partner with local or international service providers specialized in Patient Recruitment services who have demonstrated a strong track record in past studies.
b) We use social media tools (such as facebook, twitter, linkedin, etc) to advertise clinical study information and set-up a single hotline for interested participants to call.
c) We advertise the study on clinical study database sites such as Clintrials.gov, clinicaltrials.gov, NIH website, CentreWatch.com, EudraCT, ClinicalConnection.com, etc
d) We use Territory Development strategies to reach out to potential clinical investigative sites in a given region who might be interested in the investigational product.
e) We invest a lot of effort to improve communication and cooperation between Sponsors, academic research networks and investigative trial sites to maximize patient enrollment.

3. What are the major challenges to delivering high quality data in a clinical trial?

Although challenges abound in running clinical trials in general, the US Food & Drug Administration often cites deficiencies in record keeping during almost every inspection they perform. Without a proper paper trail and sound documents that capture relevant data for analysis to determine the safety/efficacy of any study medication, the quality of the data comes into question.

When creating a development plan for clinical trials, a lot of consideration has to be put into the end product, mainly, the information needed for the package insert/marketing application. The development plan must, therefore, be attacked from the other end (i.e. backwards) to meet study goals. It becomes necessary to consider what the protocol and CRFs must look like in order to achieve quality data to support the marketing application.

When developing CRFs, this should be done as a team approach, enabling input from all sides and individuals (including clinical staff, medical advisors, data management, quality assurance and regulatory affairs).

Patient compliance is also a big factor in obtaining usable quality data. Any non-compliance impacts the required sample size, hence possibly delaying the study, increasing the overall costs associated with trial management, and also decreasing the level of quality data. In order to avoid patient non-compliance issues, the following strategies can be implemented early on: reminders, newsletters, comfortable clinic visits, education, a simple ICF document (which essentially becomes the patient’s contract with the sponsor and the site), introducing a graduated regimen for more complex studies, enlisting family/friend support, and rewarding the patient’s compliance.

4. How does your company access deals and new contracts with increasing competition from the growth of the CRO industry in emerging markets?

As a Canadian-based CRO with operations mainly spanning North America, Vantage BioTrials has strategically aligned itself with partners in Latin America and Europe to provide our clients with the same high-quality services in those regions. Through collaboration with our partners, we are able to tap into regional expertise and align our standard operating procedures while maintaining the same high level of quality that the Canadian clinical research arena is known for.

Although it is almost impossible to directly compete with the low-cost offerings in emerging clinical research markets globally, we do strongly compete on the quality side of the R&D landscape. We are slowly noticing a shift back to North America from sponsors who had previously placed their R&D efforts in these emerging markets as they’ve realized that, although the short-term expenditure savings add up, the long-term cost of a trial increases as studies need to be repeated or delayed due to serious concerns of quality and integrity of data.

The key factor for accessing more deals and keeping studies in North America is to continue to improve quality, be more flexible with cost, and collaborate with all levels of industry (academic, government, client, service provider and investigative sites) to identify process efficiencies and increase recruitment speed while enrolling good-quality patients.

5. How is the current economy hurting or helping recruitment?

Ever since the economic downturn began in 2008, we believe it has had, unexpectedly, a positive increase in the number or ease of patient recruitment into clinical trials in North America. Due to lack of steady income and financial hardship for many average citizens, they are forced to “think outside the box” and consider volunteering for clinical trials that pay (for early-phase, or BE/PK/PD studies, etc) or participate in later-phase trials that cover the costs of all medical expenses. It would be very interesting to see an industry-wide survey performed regarding this issue to factually gauge the numbers.

About Vantage BioTrials:

With headquarters in Montreal, Canada, Vantage BioTrials Inc. is a Clinical Research Organization that provides superior trial management services and combines a precise blend of clinical development knowledge, talent and resources that will ensure your clinical studies full potential. We possess highly seasoned professionals, averaging 10 years experience. We also cover a vast geographical area by offering our services in North America, Latin America, and Europe.

To contact Vatche please Click Here

About goBalto: goBalto is a small team that creates simple, focused and affordable web based software for the global clinical trial industry. Our products offer drug trial sponsors the easiest possible way to start their clinical studies on the web, which makes them feel better. www.gobalto.com