Clinical studies are regulated to ensure strong evidence
Ensuring that internal procedures are well in place is important for any company as it helps assuring the quality of its products and/or services. In terms of this, pharmaceutical companies are certainly not an exception as they operate in a highly regulated industry with several rules and regulations enforced by the authorities in order to protect the health, rights, and well-being of the public.
In particular, a number of rules and regulations apply to the drug development process to ensure a consistent and unbiased collection of data about the drugs that are being tested in clinical trials. Until recently the patients have been viewed as “subjects” in clinical trials. But there is now a growing understanding that patients can provide valuable insights into the drug development – beyond what has been collected so far.
For instance, following the increasing regulatory focus on patient-focused drug development, there has been an increasing attention to advancing the collection of patient-experience data in clinical trials. However, without standard operating procedures in place, patient feedback in clinical trials may be collected inconsistently and thus the validity of the feedback can rightfully be questioned.
Building on our experiences with capturing patient feedback from clinical trials, we have identified the following consequences of not having clearly defined roles and standardised procedures in place when working with patient interviews in clinical trials:
Limited reliability of collected data
If you do not have clear procedures and systems in place to coordinate, plan, schedule, conduct, and monitor patient interviews, there is a high risk that a patient interview project will not be successful.
The fundamental challenge is that patient interviews rely on timely and correct actions from many different people at different time points throughout a clinical trial. If the patient interviews are not conducted in a consistent way this can easily question the reliability of the collected data and potentially its compliance with Good Clinical Practice (GCP).
Difficulties documenting the interaction with patients
For the safety of the patients, it is a GCP requirement to have procedures and ways that allow a reconstruction of the course of events that may take place in relation to the interview.
Planning and conducting patient interviews in an unstructured way can affect the ability to properly document the interaction with patients in a clinical trial, which can lead to critical findings during inspections by regulatory authorities.
This emphasises the importance of having clear procedures and systems in place guiding the patient interview process, as well as the importance of being able to properly document the handling of the collection of patient-experience data including potential adverse events arising from the interviews.
Excessive use of resources to handle coordination tasks
Having no standardised procedures in place to guide the patient interview process will often increase the need for people to handle the coordination of the process – i.e. coordinating who will do what at which time point. This typically results in an excessive use of resources – most often working hours – that could have been used more efficiently elsewhere by the clinical site, the interviewers, and the patients.
In addition, not having standardised procedures that everyone involved is aware of, typically causes a lot of questions to be asked – e.g. what has been done? what is next? who is responsible for this? etc. Often such questions would be answered in a standardised procedure making the responsibilities and tasks clearer to the people involved.
Standardised procedures help to ensure consistent quality of patient-experience data
Having standardised procedures in place helps making sure that patient-experience data is collected in a consistent way, which improves the reliability of data.
Standardised procedures will help the involved parties in knowing what to do, who to do it, and at which time point. Thus, it also helps ensuring that nothing is left undone. For instance, standardised procedures are very valuable to help site staff in complying with the study protocol and with GCP. Moreover, in terms of ensuring proper reporting and handling of potential adverse events, standardised procedures are key to comply with existing safety reporting requirements.
At Clinigma®, we have Standard Operating Procedures (SOPs) for the collection of personal data, storage of personal data, handling of personal data, and for reporting of adverse events.
When conducting patient interviews, we make use of a semi-structured approach, which helps us in ensuring that the interviews are conducted in an organised and consistent way, while it still allows the patients to elaborate on their answers. This provides very valuable insights on the patients’ experiences with the investigational drug.
Would you like to collect quality patient-experience data in your clinical trials?
Please do not hesitate to contact us at [email protected]