MSD says thanks to its New Zealand Clinical Trial Patients
28th May 2019. In acknowledgement of International Clinical Trials Day, MSD wants to say thank you to the 500 MSD clinical trial patients around the country.1
MSD New Zealand Director, Paul Smith says, “MSD is one of the few pharmaceutical companies undertaking clinical trials in New Zealand and our research programmes often provide patients with earlier access to medicines which are not publicly funded. As the manufacturer of KEYTRUDA® (pembrolizumab) we understand the importance of clinical trials and they are part of our commitment to bring the latest science to New Zealand.
“Clinical trials are a significant investment for us with approximately $NZ58 million dedicated to New Zealand clinical research. This funds over 500 patients taking part in 32 trials across oncology, endocrinology, cardiology, respiratory, anti-viral and vaccines. 1
“Of the 32 trials, 24 are cancer studies. These oncology trials provide free access to treatment for patients with prostate, melanoma, lung, renal, liver, bladder, solid tumours, gastric, breast, lymphoma and head and neck cancer.” 1
Surgeon James Lind started what is often considered the first randomised clinical trial aboard the Royal Navy ship HMS Salisbury in May 1747.
Patrolling the English Channel, the ship’s seamen were often struck down and killed by scurvy. James Lind’s trial of the causes of scurvy consisted of just 12 affected men, grouped into pairs and given a variety of dietary supplements from cider to oranges and lemons.
The trial only lasted six days but within that
time, there was a noticeable improvement in the group eating
fruit, providing Lind with evidence of the link between
citrus fruits and scurvy.
Mr Paul Smith says, “We should all be thankful for the foresight of James Lind and we should be grateful to the hundreds of patient volunteers who participate in New Zealand clinical trials every year. They are our partners in research and help us find better treatments for others in the future. Without clinical trial patients, new medical treatments could not be developed. However more trial participants are needed. Under-enrollment in trials is one of the greatest challenges clinical researchers face.
“Ultimately, choosing to participate
in a clinical trial is a very personal decision for
patients, but one which can significantly benefit both
individual patients and society.”
About Clinical Trials
A clinical trial is a research
study in human volunteers that tests new ways to prevent,
detect, diagnose or treat diseases. They help determine
whether investigational vaccines, medicines, or new uses for
existing medicines are safe and effective.
There are four phases of clinical trials – Phase 1 clinical trials test the medicine or vaccine in a small group of 20 to 100 volunteers who are usually healthy, and determines If the medicine or vaccine is safe, has side effects, how much is needed and how often.
Phase 2 clinical trials test the vaccine or medicine in approximately 100 to 500 volunteers. In the case of medicines, people usually have the disease the investigational medicine is designed to treat. The goals of this phase are to determine how well the medicine or vaccine works, if it is safe, has side effects and how much is needed.
Phase 3 clinical trials test the medicine or vaccine in 1,000 to 5,000 patient volunteers who have the disease the medicine is designed to treat and confirm that the medicine is effective, identifies side effects and compares the medicine to commonly used treatments.
Phase 4 clinical trials are conducted after the medicine or vaccine has been approved by the appropriate regulatory agencies and is being marketed. Researchers continue to gather information about the medicine or vaccine and its safety, side effects and effectiveness.
A participant must qualify for a clinical trial. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants.
All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results and keep participants safe.
The clinical trial team checks the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.