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International Clinical Trials

Relationships Matter

To be successful in developing new cancer therapies, sponsors and CROs need access to trained and invested investigators who have the skills and sufficient resources to offer clinical trials to patients. Without a motivated site, the process of enrolling patients into trials becomes much more challenging. Sites may view CROs as service providers who are unconcerned about the outcome of a clinical trial; therefore, CROs need to better identify the site needs and approaches that strengthen investigative site relationships in order to increase levels of ‘buy-in’ focused on achieving common goals.

Deployment of shared technology to identify patient pools at hospital institutions is one of a number of approaches that is explored here; in addition, research is conducted to understand how CROs can creatively attend to site needs, and how that can ultimately provide patients with the chance to access potentially better cancer treatments.

Ongoing Pressure

There are more ongoing clinical trials in the oncology area than any other (see full PDF). While this is a positive reflection of the commercial and not-for-profit institutional investment in cancer research, it places enormous pressure on investigational sites in terms of their own investment of time and resources.

The global spend in oncology drug development is estimated to be $9-12 billion, with up to 40% anticipated to be outsourced to CROs. Therefore, the CRO industry shares a significant part of the pressure to successfully recruit patients to clinical trials.

With quoted figures suggesting that less than 5% (US) and 17% (UK) of cancer patients have access to clinical trials (1) – which admittedly, are subject to validation and scrutiny – it is clear that in spite of the relatively high quantity of cancer therapies undergoing clinical trials, the numbers of involved patients and, by inference, sites, is unhelpfully small.

With the advent of immuno-oncology and an explosion of basket or umbrella design studies – where multiple combinations of immune-checkpoint inhibitors such as PD-1, PDL-1, CTLA4, OX-40 antibodies and so forth are candidate therapies across multiple tumour indications – the reality of many clinical trials ‘cannibalising’ the same patient populations from a seemingly unnecessarily restricted patient pool brings the problem into sharp relief.

Fundamentally, it is the investigational site that is the gateway to successful drug development. To this end, it is necessary to fully understand the drivers for, and inhibitors to, investigational site participation in the clinical trials that give access to potentially beneficial novel cancer therapies to patients. Indeed, the apparent paucity of involvement is a serious rate-limiting step to the development process, as well as a significant driver of the upward pressure on development costs. In a world where companies face a demand to reduce costs, this is a toxic situation that needs addressing.

Research Process


ICON is undertaking a study to better comprehend the key motivators and discouragements at site level. Understanding these components is fundamental to establishing stronger, better site relationships, which are less transactional and more mutually beneficial and collaborative relationships.

The structure of the study is to take an international sample of sites that already participate in clinical trials – recognising that the sample is skewed from the outset. However, with carefully directed inquiry, it will be possible to extrapolate learning to encourage new sites into the clinical development space.

Both principal investigators and study site coordinators will be targeted in this web-based survey. It is recognised that contributory facets are many and varied, but the key areas are scientific, structural, financial and cultural.

Scientific
There are pressures to answer as many scientific and clinical questions in as small a number of studies as possible; however, this urgency can be counterproductive. A reduction in the number of large, expensive registration studies (1,000 patients or more) may be expected, but instead, there is an emergence of larger proof of concept studies (up to 500 patients) – particularly as breakthrough drug designation/adaptive licensing status is increasingly sought via the FDA and EMA respectively.

These Phase 2 studies may well be basket and umbrella designs or other novel adaptive clinical trial designs, but these higher complexity protocols may be counterintuitive to mass cooperation at sites. The more complicated the protocol, the greater the chance that it is difficult to understand and comply with, leading to more interventional techniques being applied in the pursuit of biomarkers and resulting in a greater burden on both patients and research teams. This research wishes to test this hypothesis directly with sites.

Structural

In countries such as the UK, the National Institute for Health Research – as part of the NHS – provides for and encourages some protected research time for doctors. Where the healthcare system is not nationalised, doctors may have more choices to make as to how they spend their time, and may be encouraged to research with support from the likes of the National Cancer Institute in the US, for example. Other countries, like the Republic of Ireland, may not have any research-protected time at all, so the possibilities to participate in clinical trials can be structurally compromised.

In addition, access to dedicated research teams – from research nurses, study coordinators and data managers to physical space or equipment – varies from institution to institution across countries. Financial structures may also influence clinical trial participation. This research will explore this structural aspect.

Financial
Funding of clinical trials at sites is immensely complex. Hospital management boards retain the highest level of involvement in negotiating financial contacts to perform clinical trials in health establishments. Indeed, contract negotiations are increasingly becoming the greatest rate-limiting step in setting up trials in many countries across the globe. From a sample of nine recent studies across 2,654 sites in 44 countries, it was found that contract negotiation and execution accounted for 63% of the median cycle time for study start-up (2). How the money from commercial, clinically sponsored trials is distributed across departments and research staff is diverse, and research funding from national research institutions can be opaque.

Furthermore, in countries such as the US, the insurance reimbursement system can act as a negative incentive for patients and doctors to participate in experimental drug trials. After science, ethics and professional curiosity, remuneration should be a key motivator in clinical trial participation, and yet the processes for agreeing amounts and for apportioning resources could delay, demotivate and disincentivise stakeholders. Thus, further investigation is required.

Cultural

Thinking about the cultural elements of clinical trial participation beyond varying attitudes to clinical research between different countries, institutional variances also need to be addressed. The polarised outlooks between academic and community-based hospitals have already been observed; what also needs to be considered is: how important is research to career development in any particular medical community?

One can hypothesise that where research publication is pivotal to career progress, clinical trials will have a greater uptake by medical staff; however, not all research is centred on Phase 1 through Phase 3 clinical development, so it is not necessarily a direct correlate.

Another key aspect of culture is the relative relationship between collaborative academic research groups such as the European Organisation for Research and Treatment of Cancer, NRG Oncology and BIG, and the commercial biotechnology/ pharma industry and CROs. Attitudes towards all of these stakeholders influence motivational elements for the investigating physician team.

CRO Role


Arguably, the cultural aspect of site motivation is the one that CROs can influence greatly, particularly with a view to the improvement of site relationships. How CROs interface with all the key players is likely to make a significant difference to hospital research teams in the attempt to make running increasingly complex clinical trials easier. CROs also frequently act as a significant scientific champion for studies.

CROs are also at the forefront of patient-centric monitoring (PCM). PCM is growing in popularity and will be endorsed in revised EU Clinical Regulations, which come into effect in November 2016. Such approaches will make life simpler for sites in many ways and refocus site interactions away from the obsessive and, arguably, overly narrow source data verification to a more customised approach, assisting sites in yielding quality data. CROs are also spearheading electronic training platforms such as Firecrest® that make study information both more visually and intellectually compelling, and more accessible to the whole research team. Firecrest is also a platform for eConsent, which is aimed at simplifying an essential but sometimes fraught procedure for sites and patients alike, in a world where multiple consent forms for a single study are becoming more common.

Given the increasing move towards outsourcing commercial clinical trials, it can be argued that CROs should have a much greater part to play. Influencing the many additional factors that drive willingness to contribute to clinical trials is an increasingly necessary skillset that CROs are expected to provide as part of clinical trial execution. Reducing protocol complexity, shaping research infrastructure and financial engineering are all plausible if the greatest priorities of hospital oncology researchers and their patients are truly understood.

Future Prospects


This survey-based research into site relationships seeks to address priorities in order to build a holistic picture on how to best support the ever-greater pressures on oncology clinical development. Ultimately, the resulting understanding of this space will help underpin the success of the pharma industry, scientific advancement and, most importantly, the future prospects of cancer patients.

References
1. National Cancer Research Institute – UK, 2013
2. Visit: www.iconplc.com/news-events/news/icon-reports-secondquart- 4/index.xml

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With over 23 years’ experience in clinical development, Dr Martin Lachs has worked across a number of therapeutic areas, specialising in oncology. He has headed up ICON’s Oncology and Hematology Project Management Group since 2012, lending operational and indication expertise across a group of over 90 international project management staff dedicated to oncology drug development. Martin holds a PhD from the University of Manchester, UK.
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Dr Martin Lachs
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