So far in this mini blog series we’ve had a look at what decentralised clinical trials (DCTs) are, explored how COVID-19 forced an accelerated adoption of them and have discussed some of the top benefits an organisation can achieve by moving away from the more traditional in-person trial method.
Whether you are looking at decentralising the entirety of a clinical trial or are considering a hybrid approach, in this post we’ll explore a few key data concerns worth taking into account to ensure a secure and successful trial.
1 – Collecting data
The central benefit of a DCT is that the patients can be involved remotely, negating the need to travel to and from a trial site and easily integrating being involved into their day-to-day life. But the first thing to consider is how will you collect patient data and transfer it from patient site to trial site? Not only do different countries have differing rules and regulations, but it can also be the case that clinical trial sites have differing standards which you will have to meet.
If your trial is focused on the collection of patient-generated data, will it need to be collected in real-time? Security is of course of the utmost importance. Patient data confidentiality is essential to the integrity of a clinical trial, as well as storing the data so that patients remain personally non-identifiable to those externally. What technology will you use to collect, transport and analyse patient data? Will data have to be generated and collected on a particular day or date? If so, it may help to schedule these from the offset as part of the kick-off process. Will you incorporate insights gathered via eCOA or ePRO? (More on these later).
Due to their very nature, remote trials can often produce greater amounts of data from many different sources. It’s therefore highly important to ensure you have appropriate tools and processes in place to protect the data and prevent it from becoming lost, corrupt or even, risking having datasets in different locations.
Sample receipt and a reliable chain of custody will help your path to compliance, especially if your clinical trial is audited in the future. According to the EMA, “if data is generated, recorded, manipulated and stored or archived electronically, it is strongly recommended that (where possible) an electronic audit trail is maintained. The reason for any changes to the data should be justified and the justification documented. It should be possible to determine who made the change, when the change was made and for what reason.”
A digital archiving and preservation solution can support maintaining a complete chain of custody for all data stored, while ensuring the long-term preservation of the data as required.
2 – Is your technology intuitive and easy to use?
The technology employed throughout the clinical trial must be easy to navigate and integrate into daily life. Is it self-explanatory to set up? Log in to? Do they know where to go to for technological support?
If you do require more advanced programmes, applications or hardware, perhaps think about an initial run-through of the process (of course anonymously). A video call may be an ideal solution here. Testing the technology and ensuring the processes are documented within a guide will also be a great starting point for your trial.
Helping your patients feel at ease when using the technology, collecting their data or providing samples, will go a long way towards your clinical trial retention, patient satisfaction figures and most of all, data reliability and quality.
One such manner in achieving this outcome and generating genuine primary insight into the efficacy of the drug being trialled is to incorporate eCOA/ePRO. Electronic Clinical Outcome Assessment (eCOA) and a Patient Reported Outcome (ePRO) are methods of capturing primary insight electronically. These methods measure how patients feel and can be used to determine whether or not a drug has provided a treatment benefit and to gather primary insight into the efficacy of the drug being trialled. They employ mobile technologies such as smartphones, tablets and personal computers to allow trial participants, physicians and caregivers to directly report information.
3 – Retention of clinical trial data
The data your clinical trial will generate and collect – including the trial master file – will have to abide by, and meet, various regulatory requirements and data best practices (e.g. EMA for Europe, MHRA for the UK and the FDA for the US).
One of the key stipulations of the storing of clinical trial data is that it must be retained for a certain period. The EU, for example, stipulates that this data must be retained for a minimum of 25 years. Over the course of the retention period, an audit can be requested at any point in time. A clear audit trail will be necessary, whereby a record of who has accessed a document, made changes and when must be available. A digital archive and preservation solution will achieve this and ensure you remain compliant for your entire retention period and beyond (if you so choose).
Aside from inspections, there are other legal considerations to factor in as well, such as GDPR. You must be equipped with the knowledge of which data requires redacting or anonymising in order to be compliant. Is your data effectively and absolutely personally non-identifiable where it should be? Just like failing an inspection, failure to comply with the rules laid out by the GDPR could result in severe fines and reputational damage for your organisation.
Deciding on the where data responsibility lies should be identified and accepted by all parties from the offset i.e. what will the trial site own and maintain? And likewise for the sponsor? Remember, only data which requires storing and maintaining should be done so.
You must have a data management strategy defined from the outset and we strongly recommend you archive associated documentation throughout.
For further information, or for more guidance on retaining your clinical trial data, please contact us.
02 Jul, 2021
COVID: The catalyst of decentralised clinical trials?
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Three key benefits of decentralised clinical trials
27 Apr, 2021