Here at Clinical Accelerator we know that one of the major sources of delay to clinical trails is achieving sufficient levels of patient recruitment. In the next three blog posts, I will discuss some of the barriers to enrollment and ways in which these problems can be tackled. This post will focus on how to minimize patient’s fears of taking part in clinical trials.

Communication and education: Tackling patient fear

In a recent article at OncLive¹, fear was described as one of the greatest barriers to patients and families taking part in cancer trials. In particular, patients fear being a “guinea pig” or receiving a placebo instead of treatment. Clinical trials can also be complicated and confusing for patients, leading them to turn down places in promising clinical studies because they do not understand the procedures or likely outcomes. Potential patients may believe that participation in clinical trials is a last resort, or that a drug already approved by the FDA (or by EMA in Europe) would be better than a drug that is not yet approved. Participation in clinical trials also impacts upon the patient’s families, and patients may pick a treatment option that they feel will be less of a burden for their families, rather than the right treatment for them.

So how can patients’ fears be assuaged, and recruitment into clinical trials be improved? Communication and education are key in overcoming the fear-based patient and family barriers to participation in clinical trials. Healthcare professionals play a vital role in patient recruitment and the way in which they provide information about clinical trials can reassure patients and their families, and increase clinical trial recruitment.

Communication strategies for healthcare professionals:

There are several strategies that health care professionals can follow to help assist when it comes to recruiting participants:

• Engage with patients, providing information about all the treatment options including clinical trials to patients and their families.

• Involve patients in the decision-making process

• Educate patients so that they know that clinical trials offer a type of treatment rather than a placebo.

• Designate a dedicated research nurse to explain the clinical trial options in depth.

Cynthia Davidson, APRN Clinical Operations Manager for the Center for Investigational Therapeutics (Phase I Trials) at the Huntsman Cancer Institute told OncLive, “It is important to provide one-on-one communication with the patient and family on all the treatment options. Spend the extra effort needed— however much time it may be—allowing the patients to have some control over their decisions.”

Choice of communication method: Targeting your patients’ needs

Various types of media can be effectively employed to educate and recruit patients to clinical trial studies. As has been previously discussed on the Clinical Accelerator blog (Patient recruitment: is social media the cure for this headache?), the use of social media, such as Facebook and Twitter, as well as online patient communities is becoming a new recruitment ground for clinical trials, and these are also ideal places to provide information and support to possible clinical trial candidates.

More traditional methods of communication can also be important, with advertisements and word of mouth providing an essential means of education to patients. For trials in which the recruitment of patients from minority groups is required, developing relationships within the community, providing specific outreach and education, is of particular importance.

It is also vital to have the ability to address any potential language barriers. Ensuring that participants who do not share their first language with the healthcare professionals feel confident that they understand the clinical trial process and can have any questions they have can be adequately addressed, is vital to recruitment.

Financial concerns

Another important barrier to patient participation in clinical trials are worries about the costs of taking part. Depending the country of residence, these costs might include travel, time off work, and the cost of procedures, particularly if the patient is uninsured. In the United States, The Affordable Healthcare for America Act (2014) should mitigate worries surrounding participation in clinical trials and insurance, as provides protection to those taking part. However, patients may still be concerned that there will be unexpected costs that are not covered by their insurance. Some patients have limited insurance plans with minimal out-of-network benefits, and many patients do not know the rights they have within their plans.

Strategies for addressing financial concerns

In OncLive’s recent interviews, six clinical trial experts gave this advice in helping to allay patients’ financial concerns (some of these are primarily applicable to the situation in the United States and some are universal):

• Connect patients to financial counsellors or social workers to identify resources.

• Set up patient assistance programs, in partnership with private foundations and coordinate with local hotels and businesses to help with travel expenses.

• Provide reimbursement from the trial for some travel expenses, including food, lodging, and transportation.

• Advocate for patients to insurance companies.

• Encourage patient participation in the Health Insurance Exchange Marketplace.

Patient-centric recruitment

For successful recruitment of patients to clinical trials studies, communicating with candidates in a way that gives them confidence that participation is the right choice for them is key. Be prepared to go the extra mile and spend the necessary time with patients and involve them with the decision making process.

References

Tackling Patient Recruitment Challenges in Clinical Trials – http://www.onclive.com/publications/oncology-live/2014/march-2014/tackling-patient-recruitment-challenges-in-clinical-trials/