What Do Patients Expect from Clinical Trials?

Do you struggle with high drop-out rates in your clinical trials? Research shows that more than 30% of patients drop out in Phase III trials prematurely. For companies, this results in financial disadvantages, for example  recruiting a patient costs around $6,500 which is lost if a clinical trial is discontinued. For the short-term replacement of a dropped out participant, one can expect double to triple the costs.

But the immediate financial loss is not the only problem that comes with high drop-out rates; they also delay clinical trial completion. Patients who drop out of clinical trials may also be angry, potentially reluctant to participate in the future, or might cause lasting damage to the image of the clinical trials and the company conducting them. In addition, there is a loss of the previous data collected, which in the worst case endangers the integrity of the clinical study. But there are also disadvantages for the patients themselves, since they cannot benefit from the technologies or treatments used. Focusing more on the patients is therefore advantageous for both companies and participants. By better fulfilling the patient’s expectations of  the clinical trial participation, the general dissatisfaction and thus also the drop-out rate can be reduced. It is therefore necessary to pay attention to three factors right from the first planning steps:

• Patient Centricity
• Safety
• Commitment

By reducing the burden of participation as much as possible, patients should be motivated to participate actively.

But in order to meet patient expectations, these must first be identified. In this article, we address three major patient expectations and provide you with practical tips that you can implement directly.

3 ways to support patients in clinical trials

1) Create a sensitive and empathetic environment

2) Make the logistical clinical trial process clear and efficient

3) Provide information transparently

1) Create a sensitive and empathetic environment

Many patients who decide to discontinue a clinical trial feel that they are not taken seriously and/or that their needs are not being met. If they feel that the logistical aspects, such as travel and accommodation costs, are a great burden, this quickly affects their general wellbeing. In addition, patients want to feel valued by medical staff – both as participants and as humans. This includes understanding and empathy for the subjective burden they bear due to their illness and the cost of additional clinical trial participation.

Are you unsure about how much sensitivity and empathy is being shown to your participants? Then ask yourself the following questions:

• Who can patients contact if they have questions during the clinical trial?
• Do your employees who are responsible for the care of patients have good social skills?

The first step to improving patient wellbeing is to identify and designate clear contact persons on the part of the study staff. It is important that participants have a clear point of contact for problems and questions at all times. If you find that your staff’s interpersonal skills are lacking, appropriate skills-building training is a good option. You should also integrate ePRO questionnaires to learn more about patients’ unspoken problems and barriers, and resolve these. 

2) Make the logistical clinical trial process clear and efficient

The logistical and personal obstacles to a trial, such as travel time, costs, advanced age or individual health status, can be a great burden for patients. Frustrations arise quickly if the actual procedure and frequency of personal examination appointments are not clearly communicated. Therefore, these details should be considered from the outset and included in the planning. In addition, it is particularly important to actively support patients in their participation and thus enable a smooth process for both sides.

For this purpose, you should always ensure that your participants receive detailed requirements and clear information on the course of the clinical trial right from the start. Answer the following questions:

• How long do on-site visits take on average?
• What transportation options are available to reach the study site?
• Is it possible to complete the clinical trial completely or partially remotely?
• Where can participants find support for technical challenges such as televisits?

In addition, it makes sense to reduce the required on-site appointments at the study site, if possible, in order to keep the additional burden on patients caused by travel to a minimum. Hybrid clinical trial set-ups and digital data capture have proven to be particularly helpful in this respect. Televisits and medical wearables are also suitable for this purpose.

3) Provide information transparently

Patients want to be informed about a number of issues in a timely manner:

• What are the expectations of the clinical trials for the participants?
• Which advantages do patients gain from participating in the clinical trial?
• What risks does participation in the clinical trial entail?
• How will the clinical trial proceed?
• How will personal data be handled?
• What effort is required to participate in the clinical trial compared to standard therapy?

Depending on how this essential information is prepared and made available, this can either create incentives or hurdles.

In order to provide your participants with all the necessary information about the study in a transparent way, you should pay attention to the following: Prepare the information in a way that is as simple and easy to understand as possible. This includes the use of simple and instructive materials such as charts or explanatory videos. In addition, you should hold individual discussions with all patients to ensure that their treatments are optimally tailored to their indication. Last but not least, your clinical trial will also benefit from cooperating with patient advocates and patient organizations. They can help patients with any questions and problems and often prove to be valuable mediators between the study site and participants.

Conclusion: Improve clinical trials for all stakeholders with patient centricity

We often underestimate the importance of taking patient needs and expectations seriously and meeting them. Patient drop-outs are expensive and lead to costly delays and loss of valuable data. On average, 80% of all clinical trials are completed with a delay of at least one month. Such delays impact not only immediate study costs, but also subsequent drug sales.As a result, trial sponsors are faced with potential losses of between $600,000 and $8 million per day in the medium term.

Therefore, it is critical to take sufficient time in the early stages of a study to identify all measures that can support patient participation and engagement as much as possible. The most important factor in patient retention is the on-site staff and their attitude towards the clinical trial. After all, it is up to the staff responsible for patient care to ensure effective communication and thus transparently clarify any questions subjects may have – such as those regarding the expected efforts (such as time input) and potential benefits.

In addition, technologies such as apps, wearables and digital communication can strengthen patient engagement in the long term. Setting up automatic reminders for upcoming documentation, questionnaires or examinations can save time and facilitate the process for patients. In general, responsive and interactive questionnaires (ePRO) as well as the integration of further resources increase patient engagement. Medical wearables and televisits are also a great way to reduce the need for frequent on-site visits.

Want to increase your patient engagement and improve your data quality at the same time? If you would like to speak with a Climedo expert about how we can help you incorporate patient-centric elements and digital technologies into your next clinical trial, feel free to schedule a software demo or reach out to us! We look forward to hearing from you.