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Lessons Learned

Growth in oncology-based clinical trial activity continues to accelerate rapidly. The number of oncology drugs in clinical development is more than two times greater than the number in any other therapeutic area.

The National Cancer Institute estimates that the cost per patient is $120,000 for early-phase clinical trials. reports over 4,000 early-phase trials worldwide – although these numbers do not reflect the entire global market.

Key innovations in scientific methodology now power treatments targeted to the molecular characteristics of patients’ tumours. This advance provides new opportunities for patients to achieve better outcomes, but also poses fresh challenges in achieving enrolment targets for clinical trials. Furthermore, there has been a recent trend towards the inclusion of new end-points in Phase 1 studies.

An increasing number of compounds are expected to achieve a biomarker end-point in a Phase 1 study, as a requirement for advancing to Phase 2 trials. Therefore, the size of the Phase 1 study is increased, expansion cohorts may be added, and a larger number of sites are needed to enrol the trial. The increased size of these trials, in conjunction with growing competition for US Phase 1 oncology sites, has led to the need to implement a global strategy for earlyphase clinical trials.

Learning from Experience

Over the course of numerous programmes conducted in a global operational setting, we have learned many valuable lessons that apply uniquely to oncology early-phase trials. The following are the five that our teams deem most important:

1. Have an Oncologist On-Board From the Beginning
Superior results come from having an internal indication-specific oncologist join the team from the beginning of project engagement. In early-phase research, it is critical to obtain the oncologist’s input from the protocol design, through all areas of the clinical trial implementation process. This allows a company to ensure success by optimising the protocol to achieve scientific aims, appreciating the current standard of care treatment pattern, and thereby understanding the barriers for investigators and sites to implement and complete the study.

An oncologist can review study materials, treatment/comparator decisions, and even provide an overview of the site capabilities. This means that the entire study team can understand the requirements of each specific, complex oncology programme.

2. Treat All Sites With Active Engagement
In the global market, it is essential to remember that all participating sites are critical to the successful enrolment of the study. For an oncology investigator to put trust in the protocol-driven treatment, they must believe in the regimen, study design and the company – both CRO and sponsor – implementing the study. To gain trust and commitment from the sites, all the necessary steps to assist and partner with them must be completed. Important actions to help achieve this aim include:

  • Organising an investigator meeting – when possible, with detailed protocol review and Q&A
  • Setting up a site initiation visit – this should occur soon after the investigator meeting to maintain investigator/site personnel interest and motivation in enroling patients
  • Creating a study newsletter – consisting of regular value-added communication with updates from successful investigators on best practices in meeting study targets
  • Arranging an active call schedule – to offer support in all ways possible and keep the study ‘top of mind’
  • Establishing a medical monitor – meaningful communication with the sites and consistent contact for progress and support
  • Planning for serious adverse event reconciliation – this should be ongoing throughout the study
3. Use Data to Your Advantage
Using an asset such as a data warehouse can prove a useful tool to aggregate the clinical records of hundreds of thousands of oncology patients. These data can then be used to characterise current treatment patterns, prevalence of specific patient cohorts presenting to oncology practices, and other clinical characteristics which are beneficial when constructing the study protocol. In particular, these data are helpful in understanding the likely accrual rate, given the base rate of the target patient population currently in treatment in oncology practices.

4. In-Country Presence
Motivated investigators with strong research programmes prefer to work with a company that is reputable, and who also understands the local needs of the programme. A strong patient enrolment in any study requires the site to feel supported, so the study team should fully understand the local regulations in order to optimally support the investigators. Strong in-country presence means being able to assist sites in conducting the study, as well as helping them to understand local regulatory hurdles and drug import customs, implement study amendments, and fulfill the unique requirements of study laboratories – allowing them to have the ability to set up customised teams and staff.

5. International Joint Panel
The contribution of international care experts allows a protocol to be understood beyond the science, and will indicate how the programme will be accepted around the globe from a clinical perspective. An international joint panel of expert oncologists – who have experience in how a study protocol fits into a full product development plan across countries and regions – will play a vital part in the success of a product and study. Key input such as treatment patterns, local acceptance of comparators and country regulations are crucial to any programme. The experience and support they bring bridges the operational conduct of the study with the scientific involvement behind it.

Resolving Challenges

These five lessons for implementing early-phase oncology programmes were put into practice by our company recently on a very complex study. The programme required implementing a Phase 1 breast cancer trial in the US, Europe and Asia.

Some challenges the programme encountered were that study documents needed to be fully developed within very short study start-up timelines, investigational sites were unidentified, and sponsors had limited regulatory knowledge across planned regions. While the partner brought an ability to qualify the bestsuited global sites for conducting the Phase 1 programme, aggressive timelines needed to be met for completion of the study design and for protocol development, to ensure timely regulatory and Institutional Review Board submission.

A site in Asia was identified for rapid start-up and, based on the knowledge of local regulations, the global team ensured customisation of study documents, in addition to timely collation of site and Ethics Committee documents to ensure they were submitted within five working days. The global team helped in resolving queries and obtaining approval within a month of the submissions.

Improving Outcomes

In summary, the increased number and size of Phase 1 cancer trials is expected to continue to drive the need for global implementation of early-phase programmes in oncology. Given the growing complexity of most Phase 1 study designs, greater cooperation is needed between regional study staff to optimise communication and harmonise clinical operations. Study outcomes improve when decisions are informed by expert medical oncologists involved in protocol and operational planning.

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Sean Hart is the Executive Vice President and Managing Director of Vector Oncology, overseeing the Global Pharma Services team, including early-phase and observational research. His background and expertise span 22 years in building growthoriented speciality services, as well as real-world data and evidence-based solutions, including oncology and observational research. Sean previously held the role of General Manager of Product Approval and Commercialization at United BioSource Corporation, with direct oversight of peri- and post-approval research, pharmacovigilance, outcomes research, health economics, clinical operations support and regulatory affairs.

Dr Rabinder Buttar is the founder, President and Chief Executive Officer of ClinTec International. Her clinical research experience spans more than three decades within leading pharma companies. Since its inception in 1977, Rabinder has developed ClinTec into a global CRO with a strong presence in emerging markets. She has a PhD in Immunology from the University of Strathclyde in Scotland, and an Honorary Doctorate by the University of the West of Scotland. Rabinder is a fellow of the Royal Society of Medicine and the Royal Society of Edinburgh, and a graduate in Management Studies from Reading University.
Sean Hart
Dr Rabinder Buttar
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