Oncology clinical development is constantly adopting innovative approaches to enhance patient care and balance the overall well-being of the patient. Although there is significant improvement in the clinical development program of oncology, still the success rate for Phase 1 to Phase 3 is below 50%. Strategic key decision-making is necessary to enhance the success rate. Pharmaceutical companies are developing innovative trial designs and making strategies for the early selection of candidate drugs with higher success rates.
Master Protocol, an innovative oncology clinical development paradigm
Master protocol framework introduction in clinical trial design is an innovative approach that drives success considering multiple parallel drug studies performed under one protocol. It enhances the genomic screening efficiency by enabling a common platform that detects abnormalities of multiple targets. Not only the increased efficiency, but it also elevates the stakeholder enthusiasm for having a large number of biomarkers and treatment procedures. There are three broad categories of master protocols.
- Platform trial
Platform protocol runs multiple therapies for a particular single disease. This clinical trial is very effective when there are a number of available drug candidates to be assessed. It is open ended and any new interventions can be added for assessment with time.
- Basket trial
This trial protocol follows only one targeted therapy on multiple diseases having common molecular alteration. Drug developers are focusing more on molecular targetable features of tumors found in different types of cancers.
- Umbrella trial
Umbrella trial protocol applies more than one targeted therapy over a single disease. It predicts which new drug works well for patients having a similar category of gene mutations.
Advanced Therapeutics for Oncology
The advanced research on oncology clinical development inspects different cutting-edge therapies with unique clinical trial procedures.
- CAR-T Therapies
CAR-T therapies apply a genetic engineering process to the patient’s immune cells (T cells) that attack cancer cells by identifying them automatically. T cells have receptors that attach foreign antigens to them and allow the body’s immune system to destroy the foreign material. But if the T cells are not genetically engineered, they cannot predict the antigen of cancer cells.
- Radiopharmaceuticals
Radiopharmaceuticals are the radioactive form of chemical elements known as radioisotopes used in nuclear medicine imaging and procedures. It helps to treat tumors in the human body.
- Checkpoint Inhibitors
Checkpoints are the type of drugs that identify the checkpoint proteins generated by immune system cells and cancer cells. These checkpoint proteins create problems by stopping the immune system from attacking the cancer cells. For example, some common checkpoint inhibitors are CTLA-4 inhibitors, PD-L1 inhibitors, or PD-1 inhibitors.
The process of Oncology clinical development through the stages of new drug discovery, preclinical research, clinical trials and market the new drug undergo rigorous testing and it requires the intervention of professionals from different medical disciplines, such as oncologists, urologists, nuclear medicine specialists, and radiologists. The collaboration ensures that all the protocols have been addressed properly. Involving diverse expertise in clinical trial designing procedures ensures improved oncology clinical development. Enrolling online volunteers for clinical trials reduces the cost and wastage of valuable time.