The field of oncology has progressively refined over the past two decades with the advancement of in-depth, targeted therapies. This has led to an overall increase in the survival rates of cancer patients and improvements in quality of life. However, globally there is a low participation of cancer patients in clinical studies and many new strategies are being formulated to increase participation. cAlthough morbidity rates have dropped in the younger population, the cases have increased in both men and women over 50. Significant effort has been taken to study the aetiology, prevention and treatment of cancer.

Cancer is a serious health problem in Japan. For the past three decades, it has been the leading cause of death and cases are still rising annually.

Analysis of data from 647,000 cancer patients of which 326,000 cases lead to death has determined that the most likely cause of cancer is prolonged exposure to carcinogenic substances such as heterocyclic amines present in cooked fish and meat, tobacco smoke, and air pollutants. The most common form of cancer in Japan is lung cancer accounting for 49.2% of cases followed by stomach cancer at 39.9% and colorectal cancer at 32.4% (Nagao & Tsugane, 2016). An epidemiological analysis shows that nearly half of these cancers are preventable, such as those developed due to infection and smoking. It is estimated that it is possible to reduce mortality rates by up to 40%.

Challenges in Managing Oncology Clinical Trials in Japan: Advancement in therapies for cancer is rapidly transforming how we treat malignancies. Immunotherapy has become a novel and promising approach. However, these innovative solutions also come with their own challenges such as:

●          Requirement for Specialised monitoring teams and investigators – Oncology Clinical Trials need study teams which are experienced in handling such trials with expert care in the field. With rapidly changing standards of care and study designs, it is difficult for anyone to stay up to date. 

●     Early phase studies can be highly complex- These clinical trials need high flexibility with highly adaptive designs. Specialised training is often needed.

●          Recruitment Challenges – Enrolling new patients into clinical trials is challenging. It’s important to proactively plan for human resources at the sites and have effective strategies for patient recruitment.

●     New safety signals and combined therapies – The study teams should be prepared to adapt to quick re-design of protocols and follow all given safety signals for each study.

●     Specialised Laboratory Capacity – The Physicians might have to take key decisions in a short time frame. Therefore laboratories used should have a fast turnaround. There should be an efficient logistics system and an efficient report analysis process.

Improving overall subject participation in Oncology Trials: Oncology clinical trials see very low patient participation. A recent meta-analysis shows an 8.1% which is rather higher from the most often quoted value of 3%. However, the figures are still low and need improvement with better recruitment strategies. Cancer patients rely mainly on their physicians for their treatment regime. 

Patients wait to hear from their Physicians on the available treatment options for their malignancy while Physicians wait for that ‘ideal patient’ to be eligible.

What is important is to first make oncology Physicians aware of the running clinical trials. Making Oncologists aware of currently running clinical trials is an important first step to improve patient participation rates. Patients wait to hear from their Physicians on the available treatment options for their malignancy while Physicians wait for that ‘ideal patient’ to be eligible. These two factors play a key role in keeping recruitment numbers low. To improve the recruitment, it is important to:

●     Identify the best clinical trial sites to run the oncology trials. To find the best sites, 3H has an experience with sites together with investigator performance history, facility type and capabilities, and geographic data on patient distribution to ensure there are enough patients in an area with easy access to appropriate medical facilities to make running a trial in a particular location more feasible.

●     Increasing referrals from local physicians to the clinical trial sites are important. Advanced data analytics are necessary to understand the patient volume and referrals for different areas.

●     Being able to reach patients at the right point in their treatment process helps gain more patients into clinical trials. It is important to understand both the practical treatment and emotional needs of cancer patients. Recruitment talks should happen either through a centralised campaign or through a site-specific recruitment plan. Recruitment strategies should consider patient flexibility and preferences.

Why 3H is your reliable partner for oncology clinical trials? 3H Medi Solution has more than a decade of experience in the clinical trial industry. With a proven track record in achieving the target recruitment figures in various Oncology trials, 3H stands out in Japan as the premiere choice for reliable and efficient recruitment and retention of cancer trial patients. The ‘Oncolo’ website, dedicated solely to oncology patients, enables personalise recruitment strategies and use of data-driven statistics in setting up trial centres. Digitalised, smart technology in patient disease assessment have also proven to be effective tools for successful cancer patient enrolments. 3H takes oncology clinical trials to the next level through patient-centric holistic approach to suit the modern world.