Insufficient patient retention in clinical trials is a common issue in the pharmaceutical industry. It has a number of consequences for the drug development process and can be very costly for the pharmaceutical companies – both in terms of resources invested, but also in terms of missing clinical data. This cost unavoidably is later transferred to the final price a payer or patient pays for a drug at the pharmacy.
We have identified some of the challenges that pharmaceutical companies experience as a consequence of patients dropping out of clinical trials:
Pharmaceutical companies invest a lot of resources in the planning and execution of clinical trials within usually tight timelines. Some of the clinical trial costs are directly related to the patients participating in the trial – e.g. patient identification, enrolment, and clinical site visits. In order for this investment to be successful, patient retention is a key element.
If a patient drops out of a clinical trial before trial completion, the expected knowledge and outcomes collected is not obtained, and the investment related to the patient cannot be recovered and spent to obtain sufficient knowledge from another patient. Thus, the investment is considered as lost.
Missing clinical data
Besides the lost investment, the missing clinical data as a consequence of patient dropouts is a major issue. A patient who drops out of a clinical trial cannot be replaced by another patient, and all the experience and outcomes of him/her using the investigational drug can’t be recovered. The missing clinical data poses a huge challenge for the statistical analysis as it limits the data evidence base and thus has a negative impact on the ability to document the full effect and safety profile of the investigational drug in the patient. Missing data is a major concern for any company developing a new medicine.
Consequently, the major regulatory authorities worldwide – e.g., the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others – have become aware of how patient dropouts can potentially disrupt the outcomes of a clinical trial, and thus they have a huge focus on this in their evaluation of a New Drug Application (NDA).
The combination of an investment potentially not returning and the risk of not being able to show sufficient evidence of efficacy and safety of the investigational drug makes the pharmaceutical companies focus a lot on patient retention.
How to effectively mitigate patient dropouts
So, what can be done to avoid patients dropping out of a clinical trial?
First and foremost, it is essential to gain a better understanding of the reasons for patients to drop out of your clinical trial – could it be due to: The frequency of clinical site visits? The distance to the site? The burden imposed by the protocol design, i.e. many assessments per visit? Patient’s ability and willingness to be compliant with protocol requirements? Conflicts with the patient’s everyday life? Or any other inconvenience for the patient?
Often, you will be able to obtain such insights from the investigators or site staff taking care of the patient. Yet, it is not a common practice to ask neither investigators nor site staff about the details behind the reasons for a patient to drop out, which means that valuable knowledge is not captured. Even when patients do not provide a detailed reason, often the site staff has a sufficiently good relationship with their study patients to provide further insights on a patient’s rationale for withdrawing consent. However, this type of feedback from a site staff is very seldomly sought in a consistent and reliable way.
By interviewing investigators or site staff immediately after they have experienced a patient dropping out of a clinical trial, you will be able to:
- Get a better understanding of the reasons why patients drop out
- On the other hand, understand the real motivations for a patient to continue participating in a trial, despite the burden
- Obtain valuable insights to apply adjustments in the design of subsequent studies to help improve patient participation and retention in following clinical trials
Would you like to know why patients are dropping out of your clinical trials? Please do not hesitate to contact us at [email protected]