Trial drop-out rates continue to increase and some clinical trials grind to a halt due to low recruitment and retention rates. Could both be avoided by engaging a patient advocate early on to set patient expectations and allow sponsors to see the trial from a new perspective?
It’s clear that throughout the drug development cycle scientists and researchers have the patient in mind, as their treatments have a very specific goal – whether it be to cure a disease, extend or improve quality of life, the patient’s outcome is always the focus. But who focuses on the patient during the clinical trial process?
When moving into the clinical trial phase there is sometimes a breakdown of communication, which could be due to any number of factors – pressing deadlines, increased regulatory requirements, or even implicit knowledge believed to be passed onto the patient. It is at this point that clinical trials experience low recruitment rates or high drop-out rates. Could a review of the protocol by a patient advocate increase recruitment and retention? Patient advocates say yes.
An example of communication breakdown starts with informed consent. Advocates have expressed that this process is laborious and confusing to patients. 1 Studies have shown that patients prefer electronic informed consent over paper consenting processes, but many trials are still issuing paper consent. 2 Furthermore, studies have shown that the use of rich media in the consenting process has led to improved understanding and thus higher retention rates in clinical trials, but rich media and eConsent have been under-adopted by the industry. 3
With the increased demand for patient centricity in clinical trials, patient advocates can become major players in the clinical trial design process. Oncology research is leading the charge. Patient advocates are tasked with bringing the patient perspective into the implementation and planning of clinical studies with the NIH National Cancer Institute. They advocate for reducing the patient burden in clinical trial protocols, they create patient-friendly consent forms and educational materials and reduce disparities in clinical trial participation by increasing awareness and using culturally appropriate materials and methods. 3
Oncology has championed patient advocacy for years now and is bringing patient advocates into the clinical process earlier at a more rapid rate than other therapeutic areas. The rationale is that cancer treatments are often aimed at improving quality of life, and as such reducing patient burden is paramount to the trial. But oncology isn’t the only therapeutic area with incredibly sick patients. It would stand to reason that every therapeutic area could benefit from patient advocacy early in the clinical trial process to ensure patient expectations are considered from the start.
It’s simple. Our products are designed to reduce the patient burden and improve comprehension. We offer an eConsent solution that enables rich media, giving you and patient advocates effective tools to ensure that information is conveyed in an accessible and understandable format. Plus, our ePRO solution is accessible by any device from anywhere. Patients have expressed that they prefer to use their own device, and our BYOD (bring-your-own-device) model allows them to not only use the device of their choice but from the comfort of their home or wherever they may be.
Clinicians can benefit too! Our Direct Data Capture (DDC) solution allows clinicians to travel to the patient and enter data online or offline. Ultimately eliminating source data verification, when coupled with one of the fastest EDCs on the market, you’re saving time and getting treatments to patients who need them faster.
1 The Making Of A Patient Advocate For The Clinical Trials Enterprise Patrick-Lake, Bray MFS Clinical Leader 2007 Dec
2 Modifying a standard industry clinical trial consent form improves patient information retention as part of the informed consent process. Dresden GM, Levitt MA Acad Emerg Med. 2001 Mar; 8(3):246-52.
3. The Use of Multimedia in the Informed Consent Process Holly B. Jimison, PhD, Paul P. Sher, MD, Richard Appleyard, PhD, and Yvonne LeVernois, RN, MS, MPA J Am Med Inform Assoc. 1998 May-Jun; 5(3): 245–256.