Shaheen Limbada has provided tips and advice on how to recruit and retain patients for clinical trials. Limbada is the managing director of Topstone Research and has had more than 12 years’ experience in the pharmaceutical industry.
Limbada said: "Too often we see patients as a commodity or just another screening number. The focal point should always be the patient."
Topstone Research is a solutions provider at the marcus evans Evolution Summit 2016.
Just 10% of all clinical trials are completed. What is the solution?
We need to find the appropriate strategies based on each study protocol, keeping the patient as the focal point. A patient-centric approach is one of the key success factors for overcoming recruitment challenges.
What key pitfalls has Topstone identified?
Site selection is a key pitfall. Timelines to start up studies are often crunched, as a result we make quick decisions to bring on sites that we know or have used in the past, without vetting sites for that particular protocol or patient population.
In addition, we continue to not leverage the power of digital media. Digital media can help drive additional patients to sites to speed up recruitment timelines. In one recent study, Topstone increased recruitment by 292% by using digital media and ensuring the appropriate selection of sites.
What is required in a patient recruitment plan?
First, you need to identify the epidemiology of the disease, identify the patient pathway and conduct study feasibility. Once that is completed, you need to do a secondary analysis of that feasibility, picking up the phone and speaking with the sites. That will help you clarify the patient profile to ensure they have the appropriate patient database.
The next step is to motivate and engage those sites, to leverage the patients they have. It is important to look at similar studies running at the same time, understand how they are finding the right patients and what the best budget is, to ensure you are paying physicians appropriately.
You must engage your sites on a regular basis. We suggest weekly calls, which helps to identify the number of screening visits they have, if the study is paying well, if patients are enjoying the study and so on.
That helps project managers make the appropriate decisions and take actions to mitigate any risks. The last piece of the puzzle is utilization of digital media to get the most number of patients possible.
What advice do you have on patient retention?
The biggest success we have found is making patients feel they are part of something bigger. Provide information through patient newsletters that are specific to them, help them understand they are part of a large study across sites or countries.
We are also keen on study branding, giving a study a name, logo and colour scheme. In one study, we reduced the early termination rate by approximately 50% using branded milestone achievement cards.
What makes the biggest impact on getting a drug to market? What alternative approaches could you suggest?
We are a strong proponent of social media, advertising the trial using Google AdWords on Facebook, and creating banner ads that click back to a clear and concise study-specific website. With every click that a patient needs to go through you lose 50% of your viewership, so the information they are searching for should be one click away.
We raise awareness of the website through digital media, and if the patient passes the pre-screening questionnaire they are sent to our call centre. The centre is staffed by physicians, which instantly establishes a level of trust with patients.
The big piece of the puzzle is to book patients into study visits from that first call. One of the biggest mistakes people make is to raise awareness of clinical trials then direct patients to call a particular site where coordinators are not waiting by a phone.
Study participation is a decision made in the moment. You will lose patients if you give them too much time to think.