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Industry Viewpoints: Tackling Operational Struggles in Clinical Trials

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18:25, January 17 2018

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Tanja Ouimet, Pharmaleads, talks to CTA’s Alexandra Bamgboye about the operational struggles when conducting clinical trials

An ineffective enrolment strategy can have huge consequences on a study, with delays costing sponsors obtuse amounts of operational costs and lost opportunity costs. More than half of clinical trials do not enlist participants within the initially forecasted timelines, and nearly half of selected sites fail to meet their recruitment targets, while 10 percent fail to recruit any patients. Patient recruitment and site selection are two of the biggest operational issues that can have significant impact for smaller companies in particular who tend to have fewer resources.

In this Industry Viewpoint, Alexandra Bamgboye sits down with Tanja Ouimet, Head of Clinical Operations at Pharma Leads. Below, they discuss the various challenges faced by smaller pharmaceutical companies in tackling patient recruitment and site selection, all in a climate that’s becoming increasingly complex.

Alexandra Bamgboye: You spoke about patient recruitment and social media in 2017 edition of Outsourcing in Clinical Trials UK & Ireland, how is the landscape in this area at the moment?

Tanja Ouimet: There is an enormous amount of data out there and we need to know how to capitalize on this. Data is constantly around us, patients are talking on social media and this cannot be ignored. We need to raise awareness because patients are constantly discussing on these platforms. To mitigate the issues surrounding confidentiality, a solution might be to go to the source of this challenge and tell patients how to behave when in a clinical trial.

AB: Is there a protocol in place for social media use?

TO: In terms of standard practice for patients, there currently isn’t a set protocol for the use of social media. For instance, patients are not told explicitly how to behave on social media, but it is something that should be considered. The lack of guidance in this area could be detrimental, especially if a patient reports an adverse event from a product which could impact the study from a legal standpoint. However, it still makes sense to channel the potential of this platform rather than ignore it.

AB: How can we overcome the issues surrounding patient recruitment?

TO: In the past, I’ve given talks about using the internet and social media to help with clinical trials. Advertising on social media to get patients is an effective method as most people have an online presence. If you want to reach out and engage with as many people as possible, you cannot ignore how big the digital segment is.

Additionally, social media also mitigates the problem of sites recruiting patients. Nevertheless, I have come across people, working in oncology, who don’t tend to agree with online-based recruitment, arguing sites should know their patient population, and should be the sole recruiters.

AB: What would the main challenge be?

TO: Clearly regulation may be the big issue in this area, and big pharmaceutical companies may be more concerned about the legal aspect of using this type of recruitment tool. People are really afraid it would compromise the trial. Nevertheless, the impact of social media use, if maximized correctly, means faster recruitment with lower costs because far fewer sites need to be opened as they will have the good patient representation needed. It will ultimately increase the success of the trial because a high percentage of trials are failing due to patient recruitment; this is the major cause of delays.

AB: Why is site selection so difficult?

TO: Site selection is generally difficult, because you need to select good sites that are going to recruit well, so ultimately it is critical to the success to your trial. If a site is not selected correctly then the implication will be a slow recruitment process, which may not be done effectively thus costing a lot of money. At times, you may have to open more sites to achieve your objectives to compensate for the initial site that has not been successful. To mitigate this issue, we do ensure feasibility studies are conducted, and this can be done by using feasibility questionnaires which all sites are required to complete.

However, as sites want to participate they can claim they have the capacity to meet the objectives even if they cannot deliver. To truly understand the capability of the site, you must visit the site. It is only once you make a site visit that you realize things may not be working. At this point it is usually too late in the trial chain. As a community, we must create a mechanism to identify these issues earlier. A solution to this is identifying the right CRO who has worked with certain sites. However, this is still very hard for smaller companies with fewer resources. The ranking that big pharmaceuticals use to assess sites will not always apply for small companies, so it mostly comes down to the CRO you hire. Through them you can identify the right sites that fit the indication/project you are working on, which will then allow you to recognize the sites you need to work with.

AB: What other pressing concerns do you have?

TO: Funding is difficult; I have started to see CROs negotiate different contracts with smaller companies where they may give up parts of their company or product for a lower service price. If you are a really small company that is having trouble raising money to run your trials, this is a very good option. However, you need to identify the right partner, which will be an issue. Negotiating the contract may be another issue because small companies tend to have less leverage and buying power.

 

Tanja Ouimet

Head of Clinical Operations

Pharmaleads

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