From Here to There: How a New Drug is Created, Tested, and Delivered
A common misconception about clinical trials is that pharmaceutical companies are completely responsible for testing the drugs they develop. Although most clinical trials are sponsored and funded by pharmaceutical companies, the study itself is conducted in the community, including practices like Illinois CancerCare. Groups like Illinois CancerCare, through Heartland Cancer Research NCORP1, pharmaceutical sponsors, and consortiums, conduct and document drug research using a carefully-designed protocol that has been approved by an Institutional Review Board (IRB).
Formulating a Better Future
Our physicians and staff want to provide our patients with the best possible treatment, while also leading the way for even better future treatment options. That’s why research is such an important part of the work we do.
Offering our patients the opportunity to participate in clinical trials means that they may have access to newer, more effective drugs sooner than other patients. While there is no guarantee that the new treatment will work better than the current option, there are many checks and balances throughout the process to ensure optimum safety for participants.
Before the Trial
Prior to the start of the clinical trial with human participants, a pharmaceutical company conducts in-depth research on the disease or type of cancer they are developing a drug for. Researchers strive to identify biological targets that can address the symptoms or underlying causes of the disease, as well as understand the challenges of treating it.
The pharmaceutical or biopharmaceutical company then invests several years into developing the drug itself. Traditional pharmaceuticals are developed with synthetic or natural resources, while biopharmaceuticals are manufactured from living cells or organisms like yeast and bacteria. Some companies produce both types of drugs.
Once the medication is deemed ready for initial evaluation, it moves into the pre-clinical stage. At this point, it is tested in the lab or with animals to further understand its mechanisms and gauge safety. This step is important and must be completed before moving into clinical trials involving human participants.
The Trial Begins
A clinical trial is comprised of three phases led by a principal investigator, who is usually a physician (such as those at Illinois CancerCare). Prior to implementing the first phase of a clinical trial, the research protocol must be defined. The following information about the study is typically included:
- background and description
- sponsor(s) and funding entity (usually the pharmaceutical company)
- investigators (principal, nurses, other researchers)
- research sites (medical facilities like ours)
- objectives and expected outcomes
- study design and methodology
- anticipated duration for each of the three phases
- safety and ethical considerations
- informed consent forms (ICF)
- data management plan and statistical analysis
- publication policy and dissemination of results
The research protocol must be approved by an IRB to ensure that trials involving human participants meet strict ethical and regulatory guidelines.
Upon IRB approval, the researchers may begin recruiting patients for the clinical trial. The three phases of the study have been defined by the U.S. Food & Drug Administration and include progressively larger numbers of patients, typically starting with dozens of participants and increasing to thousands by the time it reaches phase III.
The quantity of patients varies based on the type of drug and number of people eligible for the study, which is one of the reasons why pharma companies work closely with clinical researchers. Physician research groups like Illinois CancerCare are able to extend the reach of clinical studies by offering appropriate trial opportunities to their patients, in the same convenient location where they receive their existing care.
When the study is complete, the data moves to the FDA for review before reaching phase IV—which is post-approval research and monitoring.
Together, We Are Stronger
With a shared goal of discovering and testing new drugs that will revolutionize cancer treatment and improve quality of life, pharmaceutical companies and medical research teams support each other’s role in bringing innovation to today’s cancer patients—and pave the way for even better outcomes in the future.
1 Through the Heartland Cancer Research National Cancer Institute Community Oncology Research Program (Heartland Cancer Research NCORP), the physicians of ILCC are able to participate in research with many large national cancer research bases, including the Alliance for Clinical Trials in Oncology (Alliance), ECOG-ACRIN Cancer Research Group, NRG Oncology, Southwest Oncology Group, the University of Rochester Cancer Consortium (URCC) as well as other top medical research facilities. Our physicians maintain a membership in the University of Chicago’s Personalized Cancer Care Consortium (PCCC) and continue to participate directly with numerous pharmaceutical companies.