By Josh Bryning
During a sponsor-blinded study the majority of the study team are blinded and do not have access to much of the clinical trial information, but the patient and investigator know which treatment has been assigned. Therefore, maintaining the blind requires an independent team with the necessary experience and knowledge to review the unblinded data for the study team, both to ensure that the data being entered accurately and to ensure that any potential safety concerns are not missed.
Why choose Pharmora?
So, why choose Pharmora to be responsible for reviewing your unblinded data? Well, above all else, we are committed to providing the best possible service for the client. This means that we strive to review the data as effectively as possible, whilst catering to the client’s needs.
As explained in the blog on UMR, Pharmora has wide ranging expertise, covering not only clinical development, but also patient safety, therefore we are familiar with reviewing unblinded data while maintaining the blind for the others in the project.
Where does UMR begin in Pharmora?
To ensure that we can deliver the best possible unblinded medical review (UMR) service, Pharmora will arrange meetings with relevant team members so that we can fully understand all their needs, helping us to provide a bespoke service. Pharmora uses this approach for all of our projects, not just UMR! These meetings will come in the form of scope meetings, where the study team can inform Pharmora on the study design. The study team and Pharmora can then work together to outline the scope of the UMR, such as choosing which electronic case report forms (eCRFs) that the study team want reviewed. Once the scope of the work is agreed, a contract will be sent outlining the responsibilities of the UMR, which both parties will agree to and sign, called a Scope of Work (SoW) contract.
Generally the UMR SoW provides for a small amount of full time equivalent (FTE) resource (e.g. 0.2 FTE) to review the data and study documents initially, slightly building at key milestones during the study but remaining low (e.g. maximum around 1 FTE) and supporting right through to the end of the need for data review.
Next step: the Kick off Meeting
Once the SoW has been signed, A Kick-off Meeting (KOM) will be arranged between the Pharmora UMR team members and the study team, to get acquainted and to agree ways of working, as well as any questions from us for the study team regarding the study setup or design. At this meeting the attendees share their understanding of the UMR process and any areas for Pharmora support, explain how we will maintain the blind, agree the format of our interactions, and our key contacts in the study team will have an opportunity to ask us any questions.
When does Pharmora UMR support begin?
The UMR team will be ready to help immediately with reviewing study documents even before the first subject is randomised in the trial (FSI), such as specifications for data listings and the unblinded data outputs, medical oversight plans, study integrity plans and clinical study protocols, to name a few. We can also review the electronic case report forms (eCRFs) and eCRF instructions, to support the team to capture all the relevant data points. The UMR team can help to extract and manipulate data listings from the electronic data capture system (EDC), if the unblinded data review tool is not ready at FSI.
Although the FTE is very low for each individual project, Pharmora understands that the needs of the project will vary considerably throughout the month, with data listings sometimes arriving monthly with tight deadlines. We will therefore assign several scientists and a medic to each UMR project (usually 3-4 people). One of these will be the main point of contact for the client study team and will carry out most of the deliverables. The other scientists will be there to support the main point of contact, for example when there is a very tight deadline for data review of a listing. These support scientists will also act as cover for the main point of contact whenever they are out of office, providing continuous cover with a seamless and assured service to the client.
How does the Pharmora UMR team work with the client team?
Once the study has started randomising patients, the Pharmora UMR team will perform routine activities, such as data review and raising queries for any inconsistencies, including discussions with Investigator site staff or clinical research associates (CRAs) monitoring the sites. The UMR team prepare and present blinded summaries to be given at a monthly catch up with the client study team. At this meeting, the UMR team will present their findings in a blinded manner. We fulfil this by ensuring all summaries are blinded and do not contain any information on treatment arm allocations, and all queries raised by the team in blinded eCRFs will be worded in a way which will protect any blinded team members from unblinding information.
For example we may pick up a need for additional site training on toxicity management guidelines, or a need for improved wording of eCRF instructions to ensure data accuracy.
Sometimes there is a safety concern from the client study team and they ask the Pharmora UMR team to perform a “Deep dive”. We perform an assessment and ensure all relevant data are entered properly and that the patient has been managed appropriately, letting the team know that this has been addressed, without letting them know which treatment was involved.
Is there ever a need to “break the blind”?
Pharmora will endeavour to always maintain the blind, and if unblinded information is requested by the client for a specific patient (for example to protect patient safety) this is considered a major issue. At the KOM we will have already discussed the process for this, which would normally include special permission from senior members of the client statistics and medical teams. A file note will then be created for this occurrence and kept in the clinical trial master file by the study leader.
Conclusion
Choosing Pharmora for your UMR needs is a no-brainer. We will help identify and resolve issues early in the clinical trial process, ensuring that less time is spent cleaning up problems further down the line when a milestone is rapidly approaching. By partnering with Pharmora from the start of the study, for the cost of only a fraction of FTE, our clients can hit their deadlines and achieve their goals.
To see how our UMR team has helped other studies, please see our testimonials here.
