4 Unique Challenges That Hinder Oncology Trials
Oncology research is moving forward at a fast pace. Despite the products’ positive results, most clinical oncology trials fail during their early stages. Apart from the cost of developing and marketing a new drug, biotech and pharmaceutical companies face unique challenges during their clinical trials. Some of them include complex Veristat clinical trial design and patient enrolment issues. Here is an in-depth look at some of the unique challenges that cause oncology trials to fail:
Missteps In The Study Design
Clinical trial planning and mapping are crucial for any study. There are laid out steps that should be considered and included to ensure the study’s objectives are met. Such steps include establishing the safety and efficacy of the drug. The linear approach developed for clinical studies does not apply to cancer clinical studies due to the temporality and heterogeneity of the diseases.
Absence Of Enough Knowledge
There’s a lack of enough knowledge for the new therapies being developed. Researchers are not aware of their full strength, making it difficult to predict their efficacy and safety. Cancer research lacks pre-clinical data and post-marketing reports, which greatly increases the program’s cost. This factor also increases the chances of failure during Phase III of the trial.
Patient Enrolment Obstacles
The success of an oncology trial depends on the oncologists, participants, patients, and the clinical staff participation from the onset of the trial process. However, many roadblocks arise from these groups, which leads to the trial failing to meet its objectives. Only 5% of cancer patients enroll for clinical trials. Some of the reasons for poor patient enrolment include lack of access to the trial site by most cancer patients. Some patients fear taking part in the unknown. This is majorly due to the lack of enough scientific information to back the trials. Also, some oncologists don’t propose clinical trials to their patients. Also, any delay by the biopharmaceutical companies to introduce their products in the trial phase leads to great losses. Therefore, it is crucial to ensure that your company enrolls cancer patients on time and comes up with enough incentive to keep them on trial to ensure its success.
Misuse of Data and Statistics
If you have data that does not have any scientific validation, it should not be used for the study. Irrelevant stats will flaw the trial from the onset. It flaws the patient recruitment process, leading to missed opportunities of reaching the cancer patients who would benefit from the new treatment. Most of the data available from academic publications and reports rely on statistics to confirm a hypothesis. It is important to be cautious with such stats, especially if the team does not have a biostatistician.
Oncology trials are faced with many challenges. The major one being that they lack prior scientific knowledge since the disease is fairly new. These trials are quite expensive, and patient enrolment is also quite low since only 5% of cancer patients enroll. The study design is quite complex since it does not rely on traditional studies.