Oncology is one of the main therapeutic areas in which clinical trials are conducted worldwide.
With an estimated U.S. market value of $100 billion by 2022, there is no doubt that cancer drugs are among the most highly-tested therapies in clinical trials across the U.S. and globally [1].
A total of 361,628 oncology-related clinical trials have been reported in the past 20 years in the U.S.. With an increasing number of new oncology compounds being developed each year, the amount of cancer clinical studies is expected to increase at an unprecedented speed [1].
The Role of Oncology-Focused CROs
With the accelerated increase of cancer clinical trials around the globe, the role of clinical research organizations (CROs) —and particularly cancer-focused CROs— has become increasingly important to help sponsors conduct phase I-IV oncology studies in an efficient, quick, and compliant manner across continents.
CROs with niche expertise in oncology —commonly small and mid-sized CROs— provide clinical trial sponsors with an attractive set of strategic advantages and practical benefits, of which we can emphasize the following: (1) a deep knowledge of the disease, (2) previous contact with oncology key opinion leaders (KOLs), and (3) established connections with cancer clinical site networks at the international level.
1.- Deep knowledge of the disease.
A deep knowledge of the disease under investigation is a critical factor to ensure clinical trial success. The personnel provided by the CRO (e.g. clinical project managers, clinical research associates, data managers) should be experienced in managing cancer trials, so that important study elements are not overlooked. For instance, a clinical data manager well versed in cancer studies can detect whether an electronic case report form (eCRF) is correctly designed to collect accurate tumor information and cancer treatment data. This added value cannot be obtained from CRO staff who are not experts in oncology.
2.- Contact with oncology key opinion leaders (KOLs).
Counting on the clinical experience of highly reputed medical oncologists will improve the quality of a cancer trial. Identifying key opinion leaders (KOLs) in the cancer type that is being studied really brings significant advantages in terms of clinical protocol insights, study design, and recruitment potential. Cancer-focused CROs that are used to manage oncology studies will normally have close contact with expert medical oncologists and they can bring them onboard to add scientific value to your trial.
3.- Established connections with cancer clinical site networks.
In the same way that having cancer KOLs involved is important, counting on the participation of the best cancer centers in each country is a goal to be ensured when executing multinational studies. Cancer CROs will be able to point you to the best recruiting hospitals in their regions, so that you do not have to waste time in finding those key sites. A good CRO partner will then save you time and effort to select the best hospitals and clinics for your oncology trial, and this is especially valuable if your study will recruit patients with rare tumors.
How Can CROs Help in Phase 1 Cancer Clinical Trials?
In the specific scenario of early phase or phase 1 oncology trials, niche CROs specialized in cancer can help ensure fast recruitment and high quality data.
Firstly, oncology CROs have had previous experiences with clinical sites recruiting cancer patients in early phase studies. They know where the best recruiters are. These already established contacts are very useful for biotech and pharma companies that have had little contact with cancer investigators and sites in the past. For example, a U.S. biotech may not know the best cancer sites in certain European and Asia-Pacific countries. Cancer CROs can then quickly identify and suggest the best hospitals to conduct a phase 1 oncology study depending on the tumor under investigation. They will already know which sites recruit best and whether those sites have the facilities and technical resources to run phase 1 trials.
Secondly, the main objectives of phase 1 trials in oncology are to assess drug safety and define the maximum tolerated dose (MTD), which is used to determine the recommended dose to be used in phase 2 studies (RP2D).
Therefore, close toxicity data monitoring is of utmost importance in phase 1 cancer trials. Adverse events must be accurately registered in the clinical database, and source data at clinical sites (e.g. medical records and laboratory values) must be closely monitored to identify treatment-emergent adverse events (TEAEs). CROs with data management capabilities play a crucial role in ensuring the quality of the safety data that will be essential to assess the main study endpoints.
What Value do CROs Provide in Large Phase 3 Cancer Clinical Trials?
In the context of large phase 3 or pivotal clinical trials —in which a higher number of patients are needed— oncology CROs can help in identifying an effective network of cancer centers in a multinational setting.
Phase 3 or pivotal clinical studies require the participation of a significant number of hospitals, and this is particularly true when the trial is planning to recruit less frequent tumor histologies or rare cancers. For example, it would be extremely difficult to complete a 250-subject sarcoma clinical trial without including clinical sites from various countries. Certain infrequent tumor types cannot be easily enrolled with the participation of U.S. sites alone. For some extremely rare malignancies, the sponsor might need at least four or five countries to complete the study in a reasonable period of time.
Then, when it comes to recruiting uncommon tumors rapidly, oncology CROs can be very useful as they normally have contacts with expert cancer centers in several countries (e.g. North America, Europe, and Asia-Pacific). These already established networks of sites to which CROs have access will accelerate clinical site identification and selection, saving time and money for the sponsor.
Sofpromed: An Oncology CRO With Global Reach
Sofpromed is an oncology-focused full service CRO with a long-standing experience in managing oncology clinical trials worldwide from beginning to end.
Sofpromed provides solid clinical trial management capabilities in North America, Europe, and Asia-Pacific, with clinical operations, data management, and statistical programming staff widely experienced in oncology, including rare cancers.
Among others, we are able to manage clinical trials in the following tumor types:
- Soft tissue sarcomas and bone sarcomas
- Gastrointestinal stromal tumors (GIST)
- Gynecologic cancers (ovarian and endometrial cancers)
- Blood cancers (leukemia, lymphoma, and myeloma)
- Brain tumors (glioma and glioblastoma)
- Gastrointestinal cancers (pancreatic, colorectal, and biliary tract cancers)
- Genitourinary cancers (prostate, bladder, and kidney cancers)
- Lung cancer
- Breast cancer
If you need a CRO to conduct a cancer clinical trial anywhere in the world, you can contact us at info@sofpromed.com
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