Last Updated on October 1, 2024
Introduction
Clinical trials are the backbone of medical innovation. Whenever a drug is discovered or a medical device is invented, it needs testing to ensure its safety and efficacy.
However, this niche is facing the daunting challenge of retaining patient count. Did you know that the average investment in retaining one patient is around $6500? After recruitment, sites face a hurdle of around 30% loss due to dropout rates. These statistics show that we should take active steps in retaining patients to minimize loss. Let’s explore them in this blog.
What is Patient Care Coordination?
Before starting with the patient care coordinator role, it is necessary to understand this term. Patient care coordination refers to the systematic organization and management of healthcare services to ensure that patients receive the necessary support at every stage of their medical journey.
In clinical trials, care coordination involves overseeing the medical, logistical, and emotional needs of participants. It involves making sure that there is adherence to trial protocols addressing any side effects they may experience. Moreover, they facilitate communication between patients, healthcare providers, and trial coordinators.
What’s the Need for Retention in Clinical Trials?
The success of clinical trials lies in effective patient recruitment and retention. As trials can proceed only with the efficient patient count, there is an utmost need for retention. And as we know that trials may proceed for years, the need for retention adds up more.
Additionally, estimates tell that around 90% of the trials fail to meet original recruitment targets.
There are a magnitude of factors behind this fact, like trial location limitations, strict eligibility, protocol complexity, etc.
Trials can have the necessary volunteer participation if they have committed resources and tactics around recruitment planning, ethical incentives, reducing patient burden, and continuous communication. This makes it possible to get accurate and timely data to ascertain genuine safety and effectiveness.
Steady progress toward market approval of crucial new medications is made possible by robust enrollment and retention, which benefits patients awaiting new therapies, drug developers, and public health as a whole.
Improving Trial Outcomes with Patient-Centricity
Retention in clinical trials is not just about a logistic concern, rather it is about the validity and success of the purpose, i.e. research. Therefore, understanding why retention is so important can help highlight the need for effective patient care coordination.
First, data accuracy is needed. If too many participants drop out, the data collected becomes incomplete, which can compromise the statistical validity of the trial results. In some cases, this can lead to inconclusive findings, requiring the trial to be extended or restarted with new participants.
Secondly, cost-efficiency is another paramount feature. Recruiting participants for clinical trials is an expensive and time-consuming process. If participants drop out before completing the study, the costs associated with replacing them can be huge. Moreover, every additional participant needed to replace dropouts extends the period for the trial. Moreover, it elevates the cost and delays the approval of potentially life-saving treatments.
Finally, retention is a prerequisite for regulatory approval. Before approving a novel medication or therapy, regulatory agencies like the Food and Drug Administration (FDA) in the United States need a clinical trial to have a minimum number of participants finish it.
Additionally, excessive dropout rates have the potential to compromise this approval procedure, resulting in additional hold-ups or possibly trial cancellations.
Common Barriers to Clinical Trial Retention
Complete understanding of clinical trial patient retention involves understanding the barrier and overcoming it. Several factors contribute to patient attrition, many of which can be addressed through effective care coordination.
The most significant barrier is the complexity of clinical trial protocols. Participants may be required to attend numerous clinic visits, undergo frequent tests, or follow strict medication regimens. For some this involvement becomes overwhelming, leading them to withdraw from their studies.
Another common reason for dropout is side effects. Participants may experience adverse reactions to the treatment being tested, causing discomfort or concern. If these side effects are not managed promptly and effectively, participants may choose to leave the trial.
Additionally, poor communication between participants and clinical staff can lead to confusion or frustration. When participants do not receive clear information about their responsibilities or the trial’s progress, they may feel neglected or unimportant, increasing the likelihood of withdrawal.
Proposed Solutions for Recruitment and Retention
Having a solid recruitment plan might seem like the bare minimum, but it’s necessary for making sure participants stay engaged and the trial is completed successfully. It’s important to plan, monitor, and think about retention right from the start.
Learning from previous trials’ challenges and putting an experienced coordinator in charge of recruitment can improve participant commitment. Both recruitment and retention plans should be flexible, as real-life patient conditions and the trial protocol can vary from site to site and evolve.
Things like the trial’s location, the participants’ socioeconomic background, and even geopolitical factors that study teams may overlook can have a big impact on how well the plan works.
Top Considerations When Creating a Recruitment Plan:
Participant Characteristics: Take into account demographics like age, gender, and background, as well as education level and their ability to stick to the trial’s requirements. Approaches for adult and pediatric trials need to be different.
Motivations: Understand why the participants are joining the trial. Is it out of a desire to help others, because they don’t have other treatment options, or for access to free care?
Barriers: Look for potential issues that could make it hard for participants to stick with the trial, such as time off work, transportation problems, or mistrust in the process (like fear of placebos).
Incentives: Finally, find ways to motivate participants, keeping in mind local regulations. This could include offering small gifts, arranging transportation, or simply showing appreciation.
How Patient Care Coordination Enhances Retention?
When things are not communicated properly, then there are high chances of participants dropping out. Thus, there is a high chance of making people understand the trial protocols, risks, and benefits. Patient care coordination can prevent this by ensuring that participants receive clear and consistent communication from the beginning of the trial.
Effective care coordination is not a one-size-fits-all solution. Each participant has unique needs, preferences, and circumstances, which must be considered to ensure their continued engagement in the trial.
The management of side effects is a main component of patient care coordination. Many participants drop out of trials because they experience adverse effects from the experimental treatment. Coordinators play a key role in monitoring participants for side effects and ensuring they receive the necessary medical interventions promptly.
Conclusion:
To conclude, patient care coordination plays a central role in advancing clinical trial retention and addresses the key challenges that lead to participant dropout.
By providing support, side effect management, logistical assistance, and financial aid, care coordinators create an environment where participants feel supported and valued. But don’t worry, Minerva Research Solutions has got your back.
Contact us today for some most efficient and streamlined patient care coordination that helps you elevate your retention rate.
