CWWeekly’s semi-monthly company profile feature, Insider Insights, interviews executives of companies and organizations in the clinical trials space. Staff Writer Ronald Rosenberg sat down with Christian Burns, president, clinical operations and marketing, of ClinEdge.

Q: What are the key issues in educating Principal Investigators to mitigate reten­tion risks and alleviate patients’ concerns about understanding and participating in clinical trials?

A: If investigators could figure out how to deliver studies as a potential alternative to medicine, patients might be a lot more open to research. If investigators could dis­cuss with potential patients more about the fundamentals of research and not focus spe­cifically on one study opportunity, we might be more successful in educating patients on the positives and negatives of joining a clini­cal study.

Generally, physicians do not have a lot of time to describe many areas of clinical re­search to potential patients. One option is for research facilities to provide patients with an iPad with an application built in to provide more details about clinical trials. The appli­cation would have a variety of videos in which physicians discuss the benefits of partici­pating in a clinical trial. These facilities also would showcase all enrolling studies on the iPad. When a potential patient is identified, the facility’s staff could hand a patient the iPad to view study details and determine if he or she qualifies.

Q: What steps does your organization pre­scribe to clients to improve the informed consent process and help study participants understand complex protocols?

A: Pharmaceutical clients have improved in this area over the past several years. They have hired companies like ClinEdge to project manage a variety of areas in the patient re­cruitment and retention process. As a vendor, we take on this task to make sure site staff are consistently updated on protocol details. Using webinars with all participating sites, we can discuss protocol difficulties and how sites are overcoming any protocol or recruitment barriers. We also would invite pharma/CROs to participate.

With complex protocols, we make sure all patients fully understand visits, procedures, blood draws and anything else that may cause them to drop out in the future. Providing protocol details early usually leads to higher retention. We have created cheat sheets for our coordinators so they have scripts on which they can initial all protocol aspects that have been reviewed, plus discuss any amendments or issues that need further review.

Q: Given the strengths of some site net­works to gain access to promising trials, what are other sites failing to do to become more successful?

A: Sites still don’t realize that you have to spend money to make money. That means understanding the cost of marketing and business development. As a network of experienced sites, the motto we use with partner sites is: our reputation is your reputa­tion. We will only submit a site for a study if we feel it can professionally conduct the study. This approach allows our network to be successful by consistently representing high-quality sites.

Some sites may be failing because they do not under­stand that in our industry your reputation is everything. If you take on studies that are not suitable, then your reputation will suffer. Sites need to better understand the importance of taking on the right studies for their organization.

Q: The quest to tap patient advocacy groups and involve trial volunteers with the protocol early is increasing. How have patients’ awareness and perspectives on trial participation changed in the last five to seven years?

A: If pharmaceutical and biotech compa­nies continue to develop strategies that improve the patient experience, patients will become more aware of clinical trials. That includes allowing patients to have a say in the development of upcoming study protocols and providing them with access to the data from the studies in which they participated.

Merck, GlaxoSmithKline, Pfizer and others are working toward making data avail­able to patients after they join a study. I am excited to see this continue to increase in our industry. By having potential patients actually comment on a study for which they may be eligible in the future may allow for better patient recruitment and retention. This concept did not exist five to seven years ago. However, studies back then were not as tough to recruit either!

If protocols are going to get tougher and the window is going to get smaller for the type of patients needed, we should involve the true decision makers. By giving patients access to the studies that they participated in, that information should increase patients’ perceptions about how they feel and that the experience was part of something great.

Q: How important is it for sites to develop a referral physician network? What steps should they take to create it?

A: An effective physician referral network will be very active in referring patients. This would include multiple physicians buying into the importance of clinical research and being able to identify specific patients based upon the studies the nearby site facility is conducting. Local physician practices will have cheat sheets with study information. When a patient is identified based on a brief outline of the study criteria, he/she can contact the research facility, which will then provide a process for the appropriate follow-up. The physician practice typically will give this patient the full background on why clinical trials may be an important alternative healthcare option.

If the potential patient is interested in learning more about clinical research based on information provided by the physi­cian practice, the site staff will contact the individual and provide more background on research. The potential trial participant will be pre-screened for the database and hopefully for a specific study opportunity. If the patient meets a study’s specific criteria, the research facility will provide transportation for the screening visit.

The most difficult part of setting up your referral physician network is getting the “buy in” from nearby practices. The most successful recruiting sites may employ one to two dedi­cated individuals not only to call potential patients, but also to consistently engage and meet with members of the referring physician network.

To create a successful referral process sites would need to hire a good speaker with sales­manship capabilities who is outgoing and up­beat. This individual will be introducing and continually reminding referring physicians of the ongoing studies and the kinds of patients that would qualify for specific trials. The posi­tion would include dropping off educational materials, giving presentations on site and conducting lunch-and-learn programs to update physicians.

If a site doesn’t have an established network, I would advise developing a list of all nearby clinics and setting up a process for introducing them to research. A few lunch and learns introducing your clinical research facility and a background on clinical studies is a great start!

Email comments to Ronald at ronald.rosenberg@centerwatch.com. Follow @RonRCW

This article was reprinted from Volume 19, Issue 02, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »