How to increase the success of your diabetes trial
By: Erica Caveney, MD | November 12, 2015
Recruiting for diabetes trials has grown increasingly complicated as more investigators compete to attract a limited population of patients, and face the constant risk of attrition and patients who fail to comply with the treatment protocol. Changes in the regulatory approval process have only added challenges to this process. To meet requirements, including evaluation of cardiovascular risk, investigators are being forced to increase their sample sizes, recruit higher risk (and thus harder to find) patients, and create endpoint-driven, intent-to-treat (ITT) study designs.
It can feel overwhelming, however it doesn’t have to be. When investigators follow these planning tips, they can improve their recruiting efforts, reduce attrition, and improve the probability of success.
Patients join trials for different reasons that are often dictated by the stage of their disease. For example, when patients begin monotherapy or insulin, they are often interested in gaining no-cost access to medicine, experts and education. In these cases, recruiters should focus on getting the word out about the trial opportunity. Whereas, patients with early-stage nephropathy or neuropathy often lack concern about their disease because their symptoms are minimal, and thus may be less interested in trial participation. In these cases recruiters should focus on educating patient populations about the benefits of early intervention to slow progression.
Knowing what motivates patients to join a trial will help recruiters craft a marketing and communication plan to deliver the best results.
Design engagements to be patient centric
One of the best ways to improve recruiting and retention is to make sure the protocol design focuses on what the patient will tolerate beyond the standard of care, and what benefits will they expect in return. For example, a patient will expect a reasonable frequency of fasted blood tests, a fair site visit schedule, minimal genomic sampling, and relatively few cognitive/psychometric tests. In exchange they may see value in updates on trial progress, and access to medications that may improve their quality of life. Factoring these benefits and tolerances into the protocol design and messaging can reduce obstacles to recruiting.
As part of this process, designers should create an informed consent form (ICF) that succinctly lays out what the patient can expect from the trial, and what will be expected of them. A good ICF delivers all of the information a patient needs to make an informed decision in an easy-to-understand document with minimal check boxes and signatures. It should include information about the study design, the patients’ rights, consent agreements, and what role the patient will play in the trial’s success.
Set expectations for 100% retention
To reduce errors and minimize attrition, investigators should be certain everyone involved in the project, including investigators, site staff and clinical research associates (CRA), and participating patients, know the role they play in achieving the goals of the project.
Investigator meetings provide an ideal opportunity to set expectations among site staff and CRAs about how outcomes must be collected in order for trial results to be valid. It is important that everyone understands not just how to collect the data, but why it is vital to the success of the program.
When speaking to patients, investigators should convey clear and consistent messaging about the commitment they have made to the study, and how dropping out would impact their own safety and the integrity of the trial results.
Provide toolkits to support recruiting and retention efforts
Site toolkits can play a vital role in supporting enrollment of the right patients for a trial, as well as reducing the risk of delays and non-compliance. These tools, which may include educational brochures, posters, consent tools, and meeting reminder apps, should complement local recruitment efforts to raise awareness about the trial and educate patients about its goals and benefits. If designers are concerned about the ability to meet recruitment goals with their existing database of patients, the toolkits can also include tools to support recruiting efforts via physician referrals, advertising and/or patient advocacy groups if appropriate.
Keep in mind that preferred tools will vary by region and country, based on what is allowed by the regulatory authorities and what is culturally acceptable or preferable to investigators and their patients.
The key to all of these tips is to be proactive. When investigators design protocols that address the needs of patients while minimizing risks to trial progress, they can avoid wasted time and effort and increase their retention rates, which is vital to any trial’s success.