Patient advocacy is not only important to patients, but it is a vital aspect during the entire clinical trial process, and all involved
The National Cancer Institute describes a patient advocate as a person who helps guide a patient through the screening, diagnosis, treatment, and follow-up of a medical condition, such as cancer. A patient advocate helps patients communicate with their health care providers so they get the information they need to make decisions about their health care. How can clinical trial professionals benefit from collaborating with patients, patient advocates and other stakeholders, and do they have the time needed to nurture such relationships?
Research program managers, for example, are often faced with the challenge of balancing the workload staff members can manage, while still achieving study targets, maintaining data quality and compliance, and often at the top of the list, staying within budget. Collaborating with patients, patient advocates and other stakeholders may just prove successful in lowering the study workload associated with patient-centered encounters.
Studies Often Collapse due to Failures in the Process
Clinical trials still often fail to meet recruitment goals and are often closed or terminated. A study of terminated clinical trials was conducted on the ClinicalTrials.gov database as of February 2013. One of the main outcomes was to identify the reasons for trial termination. Approximately 12 percent of trials with results posted on the site’s database (905/7,646) were terminated.
Trials terminate for a variety of reasons, not all of which reflect failures in the process. Further research is needed to identify best practices for disseminating the experience and data resulting from terminated trials. Such efforts can help ensure maximal societal benefits from the investments of trial participants and others involved in the study.¹ Collaborating with patients, patient advocates and other stakeholders may help to collect data on patient-related issues leading to the closing or termination of clinical trials.
Can patients, patient advocates and other stakeholders keep up the pace within the ever-changing clinical trial arena? The way clinical trials are conducted in the European Union (EU) will undergo major changes when the Clinical Trial Regulation² comes into application in 2019. The goal of Clinical Trial Regulation EU No. 536/2014 is to create an environment that is favorable to conducting clinical trials in the EU, with the highest standards of safety for participants and increased transparency of trial information. The regulation will require:
- Consistent rules for conducting clinical trials throughout the EU
- Information on the authorization, conduct and results of each clinical trial carried out in the EU to be publicly available
The Positives and Negatives of Participating in a Clinical Trial
To help prevent a further increase in patient-related trial termination, it is important that the changes in EU policies are translated in a manner that patients can understand. When considering informed consent or other patient-related information, the chosen ‘language’ must also be considered.
Patients, patient advocates and other stakeholders can help in choosing the correct language needed for specific patient target groups. Clinical trial professionals need to help patients, patient advocates and other stakeholders keep the pace. In the end, the clinical trials and the patients involved will be the beneficiaries.
What are the positives and negatives of participating in a clinical trial? In a presentation ‘A Patient Advocate’s Perspective on Clinical Trials,’³ Jane Reese-Coulbourne, Executive Director, Reagan-Udall Foundation for the FDA, mentioned the following Positives and Negatives:
- Get more information
- Better sense of control
- Attention to supportive care
- Get latest treatment or thinking
- Feel that you are doing something to help others
- Risks – No data on efficacy of your treatment
- More tests than in standard care
- Being an “interesting patient”
- No long-term follow-up
Here are some of the reasons Reese-Coulbourne mentioned why patient advocates should be included in the research process:
- Ensure that goals of patients are kept in the forefront
- Help make your trial design more patient friendly
Often, patients are not aware that clinical trials are an option, and if they do then the challenge is finding one. Patients, patient advocates and other stakeholders can help gather insight in the best ways by informing patients of clinical trials, and what steps to take in finding the ‘right one.’ In the article ‘Patient Involvement in Clinical Trials,’4 I discussed some of the challenges patients face when participating in clinical trials.
It is important to build on mutual trust. Patients need to be reassured that his or her best interest is at heart. Patients will take the opinion of friends, relatives or other loved ones into consideration before giving consent to participate in clinical trials. Patients, patient advocates and other stake holders can play an important role in helping patients feel reassured, resulting in higher patient retention and better compliance. They may provide credibility that the trial is conducted in a transparent manner.
Better Sense of Control
Patients have a better sense of control when they understand what they may expect from the clinical trial, who to approach with specific questions, and concerns. Patients, patient advocates and other stakeholders may act as a go-between to help patients better understand the clinical trial, and address questions or concerns relating to more personal issues.
Partaking in a clinical trial is for each patient a personal journey.5 Making the decision to participate in a trial requires a personal approach, personal contact and assurance. Patients, patient advocates and other stakeholders can provide psychosocial support to patients and families. The can help ensure patient goals are a priority.
Collaboration between patients, patient advocates, other stakeholders, and clinical trial professionals is vital. It’s a collaboration which will help improve patient support, help with education and information dissemination, reshape the research process and help influence regulatory bodies about patient reimbursement, and patient needs.
Founder and President
1) Terminated Trials in the ClinicalTrials.gov Results Database: Evaluation of Availability of Primary Outcome Data and Reasons for Termination. PLos One. 2015, 10(5): e0127242. Published online 2015 May 26. Doi: 10.1371/journal.pone.0127242