February 2016 l ICT 35

Q&A: Oncology Research ICT

With almost half of oncology studies failing due to a lack of patient retention, there is a critical need to develop more efficient and patient-focused strategies. Jessica Thilaganathan at CRF Health explains why electronic clinical outcome solutions could be the answer

offer opportunities to facilitate solutions to the specific challenges presented by oncology studies – and should be planned for at the study design stage.

What are the current challenges when it comes to ensuring high-quality outcomes in oncology studies?

One of the biggest challenges in oncology trials remains the recruitment and retention of patients. More than 40% of studies fail at the first hurdle because they cannot recruit or importantly, retain enough candidates. In terms of recruitment, the increase in personalised medicine – combined with the huge number of indications of cancer – can make it difficult for sponsors to even source enough suitable patients to screen for a particular trial.

ICT: What is unique about clinical research in oncology?

Jessica Thilaganathan: Oncology encompasses so many diseases and indications that there is no ‘one-size-fits-all’ approach to clinical research in this area. The symptoms, severity and progression of disease in different kinds of cancer can impact the patient’s ability to participate in trials – from initial recruitment and on through the course of the study. Oncology studies can also be notoriously long – up to 10 years in some cases. Maintaining patient involvement and enthusiasm across this period can be a significant challenge.

Protocols should therefore be prepared with sufficient consideration for such timeframes. Study teams should be trained and remain engaged, while staff turnover and retraining should be managed appropriately. Reducing patient burden and offering engagement strategies can make a real difference to patient retention and compliance. Electronic clinical outcome assessments (eCOA), for example,

Jessica Thilaganathan is the Therapeutic Areas Coordinator at CRF Health, based at the company’s office in London, UK. She is responsible for supporting and coordinating the development of the company’s products and services,

ensuring that they meet the needs of high-quality eCOA clinical trials across diverse therapeutic areas and indications. Jessica is passionate about creating eCOA solutions that fit naturally into patients’ lives and behaviours in clinical trials. She holds a Master’s in Medicinal Chemistry from the University of Leeds.

Email: jessica.thilaganathan@crfhealth.com

Putting the Patient First

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For those studies which do recruit enough participants, it can be tricky to retain them throughout its duration. One of the reasons that patients regularly cite for withdrawing from an oncology study is that, with an often limited life expectancy, they have not seen any benefits to their health early on in the trial – and so they decide that they would rather not spend any time they potentially have left participating in a trial.

Another key obstacle is managing the large volume of data that need to be collected, recorded and analysed during the studies. Moreover, research released last year showed that COA adoption is expanding in oncology. When protocols include a high number of patient-reported outcomes, they can be quite complex, with a lot of visit cycles and different routines involved. This can increase burden on the site and impose more site visits – and thus travel – on the patient. Unfortunately, we have seen this lead to site pushback – more so than in other therapeutic areas.

How can sponsors and CROs maximise the value of patient-reported outcomes in these trials?

When retention and engagement are a problem, being able to access eCOA data in as near to real time as possible is essential. If study teams are able to review the data which patients are reporting almost immediately, they can predict study patterns, as well as detect low compliance or worsening symptoms, and address issues before the participant drops out. By achieving a high patient compliance and retention rate, sponsors can expect lower overall study costs in the next phase, along with shorter time to market, and less risks associated with resulting regulatory submissions.

Unlike traditional paper-based methods, eCOA solutions provide sponsors with this real time access to data. For example, if patients are reporting high pain levels, this would be flagged to the study team through the eCOA system – enabling them to call individual participants and recommend a solution, or provide new medication, for example, rather than wait for the site visit. Site staff will also be able to adapt any upcoming visits accordingly in order to focus the discussion, rather than simply providing a generic site visit appointment. By increasing engagement with the patient throughout the duration of the trial, and maximising benefits to them, sponsors can expect to see improved retention levels.

How can the use of eCOA improve an oncology study?

As well as enabling more complete data collection, boosting patient engagement and managing participants in real time, the implementation of eCOA has additional advantages for oncology studies.

Firstly, eCOA will automate processes to reduce workload and support with the growing number of patient-reported outcomes used in oncology studies. For example, through unique scheduling tools, study staff can arrange or organise site visits and be reminded as to when – and in which order – to complete questionnaires, so that all data is collected,

consequently reducing the level of burden on study sites and aiding staff in staying protocol-compliant.

The use of eCOA also supports patients, by providing useful reminders or motivational messages. In addition, if a participant’s condition deteriorates and he or she is no longer well enough to visit the site, eCOA allows for remote data entry via the internet, phone interviews, or the ability to send devices home – thereby further reducing burden compared to pen and paper methods, or manually entering physiological readings. This is especially important when dealing with very sick patients, and can help them to remain in the study for as long as they wish.

As previously mentioned, eCOA can also help sponsors achieve better patient management by using built-in reports to ‘flag up’ if they are experiencing a lot of pain. Furthermore, these solutions can allow participants to easily report any concomitant medication taken during the trial – ensuring that sites and sponsors can obtain high-quality information on their complete medication list for the duration of a study. This, in turn, can help sponsors prove the true efficacy of the drug and therefore meet regulatory requirements.

Patient-centricity is widely regarded as being at the forefront of high-quality clinical research. How can eCOA help sponsors deliver a more patient-centric oncology study?

While patient-centricity in clinical research is not a new concept, in recent years, the industry has moved from just talking about it to actually putting it into action. There is no doubt that the increased adoption of eCOA in clinical trials has been a part of this, by offering intuitive and easy-to-use solutions that fit in with patients’ everyday lives.

The majority of oncology trials are still carried out through site visits and, as many will agree, are increasingly admin-heavy, with the number of tasks listed in study protocols growing ever larger. eCOA solutions support patients and staff during these visits by ensuring the capture of high-quality patient-reported outcomes in a timely manner – consequently lessening the burden on both parties. Through the use of dosing diaries, appointment reminders, real time data input and so on, eCOA solutions also enable smarter communication and conversation between all those involved in the study – improving outcomes and the overall experience for patients.

'Bring your own device' strategies are increasingly being adopted across the industry. Is this approach suitable for oncology trials?

Promising a number of benefits, the bring your own device (BYOD) model is definitely a hot topic at the moment, with many companies keen to explore this approach. That being said, BYOD adoption within the industry has actually been quite slow. Sponsors are reasonably hesitant, due to the lack of official guidance on the suitability of the methodology, as they have no guarantee that the supporting data they capture in their study will be accepted by the regulatory bodies.

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As far as oncology is concerned, while web-based diaries are currently proving a great way to collect data when patients are too ill to attend a site visit, the industry is still quite a way off from running these types of clinical trials via patients’ own devices as standard practice for every trial. This is partly because there are still a number of challenges to overcome before BYOD can be used as a viable alternative to traditional eCOA data collection methods – particularly in complex oncology trials. These include addressing the potential bias of technology ownership, gaining clarity on the regulatory viewpoint, and examining the equivalence and comparability of data captured across the wide range of devices that could be potentially involved in a BYOD trial.

While there is no doubt that BYOD has the ability to transform clinical research and improve patient experience in the future, for now, the design of hybrid studies that mix BYOD with provisioned devices offer a perfect starting point for sponsors wishing to take their first steps to employing the model.

What is your advice to sponsors and CROs looking to implement an eCOA solution within their oncology trial?

While it sounds obvious, understanding the patient’s perspective and needs should be at the heart of the trial. Ultimately, the patient is the expert on their own experience, and their perspective is something that needs to be captured in order to improve their quality of life.

My advice would also be to think very carefully at the protocol design stage about the number of questionnaires – and which ones – will be used, and to try and strike a balance between generic and oncology-specific questions. There is often a desire to capture as much data as possible, but one must think carefully about what this data will actually be used for, and focus on the most powerful outcomes. Sponsors should also ensure that any specific population’s needs are incorporated into the design from the beginning, and consider the added value that electronically captured data can provide based on desired endpoints. For example, if pain management and/or the ability to track the use of concomitant medication use is an important factor, this should be considered in the design.

What does the future look like for eCOA implementation in oncology studies?

eCOA offers huge benefits to oncology trials. Its ability to reduce burden on sick patients and site staff, support engagement and communication, prove the efficacy of drugs, increase data accuracy and compliance and, crucially, improve patient retention and recruitment, make it an unrivalled data capture solution in this therapeutic area.

The use of eCOA in oncology will continue to grow year on year, with this ever-evolving technology promising more patient-centric, innovative trials to address this most challenging of therapeutic areas.

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