If clinical trials are the paths to creating a healthier world, early phase trials are the signposts. They establish what doses, if any, are safe enough for further study. In oncology research, there are additional aims. Generally, a drug or treatment is developed that leverages a specific natural pathway to kill or stop the growth of cancer cells, and researchers are trying to test what is the minimum amount of the drug that a patient can receive in order to show efficacy while experiencing minimal side effects.
Most of the patient profile is also different in early phase oncology clinical trials vs late phase research. Many people who choose to participate in these trials often have faced a failure in their treatment paradigm, like chemotherapy. In some cases, the cancer may have advanced or metastasized, and participation in an experimental trial allows patients to help others while introducing a possibility for improvement. It’s an option explored after other avenues have been exhausted, but that doesn’t mean participation in early phase oncology research might not be effective. Medicine is changing and becoming more precise. Targeted therapies have the potential to be extremely effective for some people.
Further, it isn’t uncommon for an early phase oncology trial participant to join a different clinical trial if the one they are on isn’t working or has too many side effects that cannot be managed through other efforts. One recent study suggests that over half of Early Phase Oncology trial participants have received two or more prior therapies while 1 in 4 had five or more. While one trial might not have been a good fit for a person, that doesn’t mean the second (or fifth) one won’t be effective.
To get a better idea of what early phase oncology research looks like, we will use Citeline, a clinical trial intelligence platform, to outline what the Phase 1 and Phase 1-2 oncology clinical trial landscape looks like today.
To date, over 1.7 million people have participated in an early phase oncology clinical trial, and there have been over 35,850 trials. Around 9,500 of them are active. Here is a breakdown by status.
Looking at Early Phase Oncology trials, we can see the vast majority are traditional Phase 1 Oncology trials. While Phase 1-2 trials have their merits—establish toxicity and efficacy at the same time, often in a trade-off—they aren’t always a good fit for Early Phase Oncology Research. Phase 1 trials often make more sense when safety or dose toxicity is unclear. Further, having a Phase 1 Oncology trial instead of a Phase 1-2 oncology trial allows for more exploratory work, like tissue sampling or molecule profiling. It also can make more sense from a regulatory perspective.
Let’s also look at Early Phase Oncology trials by their start date. This gives us an idea of the pipeline for new drug development as well as the competitive landscape and industry timing.
Looking at planned and ongoing Early Phase Oncology trials by site location is also interesting. Here are the top 10 site locations for Phase 1 and Phase 1-2 Oncology research around the world.
|
Countries |
Count |
|
China |
4620 |
|
United States |
3757 |
|
Spain |
649 |
|
Australia |
624 |
|
France |
553 |
|
Japan |
474 |
|
United Kingdom |
451 |
|
South Korea |
432 |
|
Canada |
401 |
|
Germany |
357 |
Citeline Trialtrove® – 04OCT2024
At Precision for Medicine, we have worked on more than 200 early Phase Oncology trials which represent over 60% of our oncology trials. We are committed to supporting our Sponsors through every phase of drug development, starting at First-In-Human.
While the Oncology industry is more of a 70/30 split between Phase 1 and Phase 1-2 clinical trials, our experience is more balanced. While we have worked on 88 Phase 1 Oncology trials, we have also worked on more (107) Phase 1-2 Oncology Trials.
Citeline Trialtrove® – 04OCT2024
Precision’s experience in Early Phase Oncology trials dates to the start of our company, and we have consistently grown in that space ever since allowing us to develop and grow our expertise in running these complicated and such important trials.
Citeline Trialtrove® – 04OCT2024
Precision has worked with sites located in all the places where Early Phase Oncology research is happening. The sun doesn’t set on our Phase 1 and Phase 1-2 oncology studies.
Citeline Trialtrove® – 04OCT2024
Precision for Medicine’s Early Phase Oncology experience encompasses solid tumors as well as hematology-oncology and hybrid trials.
Citeline Trialtrove® – 04OCT2024
We have also had the opportunity to participate in a large number of First-in-Human (FIH) trials.
Citeline Trialtrove® – 04OCT2024
Precision has also supported many Immuno-Oncology (IO) trials.
Citeline Trialtrove® – 04OCT2024
Precision for Medicine has had the opportunity to participate in hundreds of Early Phase Oncology trials in locations around the world. We know what those regulatory bodies want and what local patient populations need. We are also versed in different drug targets and mechanisms of action, so we understand how to best manage your screening process, how to consistently evaluate progress, and how to best support your drug development goals.
See how Precision can support your next Early Phase Oncology drug development program, and together we can create a healthier world.