Major themes of taking the burden of oncological clinical trials away from the patients themselves to stabilise and streamline research took hold of audience members at the 2024 Clinical Trials in Oncology conference in Munich.
The two-day event included talks on subjects ranging from how to best utilise artificial intelligence (AI), to how to build a stable clinical research organization (CRO). The big themes running through many of the talks focused on how taking away the burdens of commuting, paperwork and confusion from patients, is the easiest way for an oncology trialto succeed.
Taking over the conference rooms of the Munich Sofitel hotel on December 3, the floor played host to numerous industry stakeholders for a selection of panels and talks delving into the mechanisms of conducting cancer trials.
The conference followedresearch by the oncology market is set to emerge as the largest therapy area by sales, poised to generate $2.2 trillion in sales between 2023 and 2029. As a result, this has driven a significant amount of interest in the space but amid all the drive to develop new and novel therapies for people living with painful and life-threatening conditions, patient鈥檚 priorities could be lost.
Day one 鈥� Too much and not enough
On the first day of the event, researchers were or lack of record-keeping to put patients at risk. Patients who, amid their own stresses and life factors, now must juggle a myriad of inconveniences and inexplicable tasks as part of a clinical trial they hope will impact their cancer diagnosis.
This was the case in the talk, 鈥淐linical research needs a moonshot: What patients can teach us about innovation鈥� led by vice president of patient engagement for Medidata Dassault Systems, Alicia Staley, who detailed her long and emotional journey living with multiple forms of cancer, having endured a myriad of treatments and trials.
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By GlobalDataStaley is a survivor of both Hodgkin Lymphoma and breast cancer, having initially been given her diagnosis whilst still studying at university. She urged attendees to ensure that patient records are always stored and accessible appropriately, telling delegates about one medical device trial that saw a small amount of radioactive material, through a method known as seed radiation, causing her severe pain and at risk of quitting the trial altogether.
In another instance, Staley told how she was forced to physically walk to image scans taken of her body at one Boston hospital over to another, purely because neither hospital had the ability to share those images with the other. In another instance, she discussed rejecting a trial early on purely because of a deluge of non-helpful information. In another, she discussed how poor record keeping over how much radiation she had received in a previous trial caused another trial to make assumptions and leave her in pain.
鈥淯ltimately, we learned after the trial started that incomplete information in my medical record put me at a higher risk for trial failure due to previous radiation amounts.聽 This led to a tough trial experience.鈥�
It was only after direct encouragement from her mother that Staley was willing to continue the trial. Now, she is urging healthcare firms to ensure that their clinical trials not only keep rigorous, searchable, and accessible records for all patients to avoid the assumptions that would cause pain or vulnerable patients to reject the trial together based on a lack of readable or concise information.
Later that day, a round table discussion that saw Staley joined by colleague and vice president of patient engagement at Medidata Dassault Systemes, Sarah Westall . The pair were joined on stage by patient advocate Justus Harris and COO for Node Pharma, Helen Johansen Blanco.
In that talk, the panel discussed how one of the core difficulties with using imaging in oncology trials presents a whole world of difficulties given that imaging devices are large, expensive and almost impossible to reasonably decentralise. This makes it difficult when trying not to get a patient to have to commute too much, but they have to be brought to a site occasionally or even frequently for some form of medical imaging.
Sarah Westall pointed out that the industry is getting ahead of itself in implementing new technology into trials without real consideration as to how it will work for the patient.
Westall said: 鈥淚t feels like we are jumping from imaging feeling like this new thing we have to figure out how to manage as data managers, to how do we decentralise this? Unlike some things you can decentralise, with imaging you can鈥檛 just go putting an MRI scanner into someone鈥檚 front room. Usually, we have unwell patients travelling long distances to get to trial sites and it鈥檚 a lot to ask. It is a balancing act.鈥�
Responding to Westall, Helen Blanco iterated that Node Pharma trialled the use of satellite trial sites throughout the Covid-19 pandemic but found that the regulatory burden in sharing data gathered in those satellite sites presented a significant challenge that made the system difficult to work with.
She went on to add that the group had seen some success retaining patients when they cut the rate at which patient surveys were carried out from once per six weeks, to once per nine weeks, lessening the paperwork demands on patients.
One thing the panel was keen to iterate as a primary motivator for anyone undertaking a clinical trial, especially in the oncology field, is that the patient has a solid understanding of what they are doing, why, and how it benefits them and their treatment journey. Patients are much more likely to drop out of a trial if they don鈥檛 feel as though what they are doing is either making them better or advancing their treatment. Especially if some of those patients are dealing with the prospect of a limited amount of time left.
Day two 鈥� Paperwork and efficiency
On the second day, a talk from US-centric software company Suvoda reiterated some of the same points, whilst detailing not only have the potential to burn out patients before they are able to progress in the trial, but the same issue will end up impacting the overall success of a trial.
Led by senior solutions consultant at Suvoda, Daniela Duffett detailed that as a result some sponsors and CROs could see their trials fall behind deadlines if they aren鈥檛 willing to streamline some processes surrounding participant comfort.
Duffett said: 鈥淭his company started with the data they wanted, then listed off to us all the different questionnaires they needed, and they ended up with a long and complicated list of questionnaires, their argument being that these were the questionnaires that were necessary to get the data that they needed for their trial.
鈥淲e took a look at it, and we advised them that they would have a few problems. Participants desire flexibility and simplicity in their use of technology. There were some questionnaires that were repetitive, and from a patient’s perspective they might not always enter the same data and if you end up with conflicting responses that鈥檚 going to be a nightmare for you. Having many long questionnaires it鈥檚 also going to impact patient compliance and reduce the number of questions they answer. It鈥檚 also important to give patients the option to download the Suvoda eCOA app or be provisioned with a device to answer these questionnaires, giving them flexibility in their choice.鈥�
Suvoda again reiterated to attendees that it is vital to the smooth running of a trial that oncology patients – patients who by the nature of their condition are being forced to make difficult choices about their time and wellbeing – require some thoroughness to be surrendered.
Not every data point is relevant and not every questionnaire needs to be completed in order to achieve a successful endpoint, but every question and data point is yet more work expected from a population of largely unpaid patients.
Impact and real world data
, GlobalData鈥檚 Ophelia Chan took over the stage to argue that the judicious use of real-world data (RWD) and intensive before-hand research can keep a trial from collapsing whilst keeping matters relatively streamlined.
Touting the capacity of GlobalData鈥檚 various healthcare-centric intelligence centres, Chan detailed how the market for oncology treatments for indications of non-small cell carcinoma (NSCLC) is expected to grow by more than 40% by the end of the decade, resulting in a drive to invest in the industry and a surge in competition.
In her presentation, Chan detailed how if oncology trials do fail, they fall at some of the earliest hurdles with Phase I and II trials being some of the hardest to recruit patients for. Sharing a snapshot of the current oncology trials landscape, the talk detailed how in the NSCLC space there are currently 4400 ongoing trials, with an additional 27 drugs currently in the pre-registration phase.
Chan said: 鈥淟ow recruitment rates were the primary reason for the failure of NCSLC in 2019, as a result, there could be possible gaps in our patient access or engagement programmes which could be addressed through a targeted outreach programme or through decentralised trials.
鈥淭argeting patients with specific biomarkers could also streamline enrolment, it would increase overall efficacy rates and shorten the trial duration, biomarkers can also help us identify susceptibility to specific adverse events allowing for much more targeted tracking of some patients.鈥�
GlobalData is the parent company of Clinical Trials Arena.
Chan closed out her talk and in turn, the event iterated that sponsors are unlikely to get the results they are looking for unless they are willing to reduce some of the stress on potential patients to keep them involved.
Throughout the two-day conference onemajor theme continued, that taking stress away from sick and worried patients and keeping them engaged is the difference between a trial succeeding or collapsing.
Whether it is cutting down on needless paperwork, or making them only commute when necessary, patients need to feel cared about and included in trials in order for the trial itself to succeed and not have sponsors see their money wasted.
