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How to Engage Patients In Order to Drive Compliance and Create Robust Clinical Data

October 25, 2016
Posted by: Jamie Zacher, PharmD

Patient engagement is crucial for any clinical trial to have good, reliable and robust data. The challenge, therefore, is to keep patients engaged and feeling valued because patients who are not engaged and are not feeling valued, are more likely to drop out.  And drop outs costs the sponsor company additional time, money and resources to complete their clinical trial.

Patient engagement starts at the site immediately when the patient is enrolled. Patients must be properly educated on all aspects of the study. As they receive education about the trial, the medicine and/or procedure, they gain confidence that they can indeed adhere to the protocol requirements.  This confidence leads to increased patient engagement in the trial. And, increased patient engagement and understanding leads to an increase in adherence, enhanced trial outcomes and a decrease in drop out rates.

For better patient engagement, clinical sites and sponsor companies often times provide patients with educational handouts and now a days,  videos which contain all the information the patient needs to be an active and engaged patient in the study.  However, there is more that can and should be done to maximize the opportunity for success.

Here are a few simple options to follow to keep patients better engaged in clinical trials for enhanced compliance and more robust data.

1) Once patients are home, study personnel can use other methods to keep patients engaged in the trial. Study personnel may send out mailings or emails to patients to provide additional educational information about the study, provide updates or changes to the study, remind patients to take their medication and remind them of upcoming appointments.

2) Sites can use text messages and recorded phone messages to keep patients engaged. These messages can remind patients of an upcoming appointment or to take their medication. Study personnel may also choose to use Skype to have more direct contact with patients in between their scheduled site visits.

3) Adding a pharmacist to the clinical study health team can also help to keep patients engaged. Pharmacists are medication experts who can provide valuable information and timely support to patients. Pharmacists are able to provide a deeper level of communication to the patient including medication and protocol education as well as counseling and support during the trial. The abundance of information patients get at the beginning of a study can be overwhelming. Patient counseling by a pharmacist can reinforce the information patients learned at the site, as well as answer any additional questions the patients may have. Pharmacist calls and visits conducted between site visits provide another valuable opportunity to keep patients engaged in the study.

Patient adherence and retention increases when patients feel supported and informed during a clinical trial.  And clearly, patent adherence and retention is key to the success of any trial, as data from non-adherent patients can adversely affect trial results to the extent that a drug or procedure is rejected for market approval.[1] Because of this, patient education and engagement is crucial to supporting the best and most unbiased trial results possible. The optimal way to ensure that this occurs is by using a combination of the methods discussed as well as including a pharmacist on the clinical trial healthcare team.

 

[1] Lamb, M. Improving Patient Compliance in Clinical Trials, Smart Packages or Smart Design. http://ecm.cachefly.net/pdf/Improving_Patient_Compliance_in_CTS.pdf

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