Home / The Clinical Research Process to bring a new Drug to Market
The pharmaceutical industry is the main sponsor of new clinical research. Before any new drug or medicine can be bought to market, the Sponsor or Developer must prove the drug does what it is intended to do, all side effects are known and understood, and it is safe for humans to take.
Proof of a drug’s efficacy and safety is the responsibility of the drug manufacturer and providing this information to the regulatory bodies requires following strict protocols.
Broadly, the different phases of developing and testing new drugs is:
NZCR’s role in this process is to undertake the Clinical Research in NZ and provide the findings to the sponsor for review and submission to Medsafe (or a similar overseas regulatory body) for approval.
While preclinical research answers questions about a drug’s safety, it is not a substitute for studies of ways the drug will interact with the human body. “Clinical research” refers to studies, or trials, that are done in people.
The clinical trial follows several steps.
Developers design the clinical study by considering what they want to accomplish for each of the different Clinical Research phases and then begin the Investigational New Drug Process (IND). Researchers review prior information about the drug to develop research questions and objectives. Then, they decide:
NZCR will often have input into the final design of a study.
Drug developers, or sponsors, must submit an Investigational New Drug (IND) application to Medsafe and HDEC (Health and Disability Ethics Committees) before beginning clinical research.
In the IND application, developers must include:
NZCR submits the IND to Medsafe and HDEC for approval. The sponsor may also complete an IND to submit to the FDA (Food and Drug Administration) if they want to use the study findings in the US.
Trialing a new drug or device can go through several stages and must be approved at each stage before moving on to the next. Clinical trials follow a typical series from early, small-scale, Phase 1 studies to late-stage, large scale, Phase 3 and 4 studies.
Phase 1 of a study would typically involve 20 to 100 study participants, either healthy volunteers or people with the disease/condition. The purpose of this stage of the study is to determine the drug’s safety and correct dosages and can last for several months. Approximately 70% of drugs move to the next phase.
Phase 2 can require several hundred study participants who have the disease or condition. The length of the study can be several months to 2 years and the researchers are looking at efficacy and any side effects. Approximately 33% of drugs move to the next phase.
Phase 3 continues to evaluate efficacy and monitoring of any adverse reactions. This part of the study can take from 1 to 4 years and involve 300 to 3,000 volunteers who have the disease or condition. Approximately 25-30% of drugs move to the next phase.
Phase 4 continues to monitor several thousand study participants who have the disease or condition for safety and efficacy.
The review team consists of a group of specialists in different scientific fields. Each member has different responsibilities.
If the drug successfully completes the medical research, the company submits a New Drug Application (NDA) to the regulatory authorities. The NDA contains all the data from preclinical and clinical studies, including detailed information on the drug’s efficacy, safety, and manufacturing processes.
Medsafe reviews the NDA to determine if the drug is safe and effective for its intended use. This review process can take several months to years, depending on the complexity of the drug and the data presented in the NDA.
If the drug is approved, the company can begin marketing it to healthcare providers and patients. The drug company must continue to monitor the drug’s safety and efficacy and may be required to conduct additional studies or provide updated labeling information as new information becomes available.
Medsafe continues to monitor the drug’s safety and efficacy through post-market surveillance programs, which track adverse events and provide updated information on the drug’s risks and benefits.
In summary, bringing a new drug to the market involves many phases, all designed to ensure both the safety of the drug on potential users and its efficacy – it does what it says it will do.
NZCR follows best practice guidelines to ensure the safety of all participants and is audited continually during the trial for both effectiveness of the drug and any side effects.
New Zealand Clinical Research (NZCR) provides state of the art research facilities and the expertise to conduct complex early phase clinical research in healthy participant and patient populations.