It  takes  many  years  of  research  and  testing  before  medications  come  onto  the  market. Evidence  is  required  to  show  it  is  safe,  and  that  it  works  as  well  as,  or  better,  than  current standard  treatments.  The  process  of  acquiring  this  evidence  is  very  tightly  regulated  and involves  performing  clinical  trials.  Sometimes,  even  if  a  drug  has  been  approved  for  use  by international regulatory bodies, it may still need to be clinically trialled here in Australasia.

Running a clinical trial in New Zealand

To perform clinical drug trials in New Zealand, the study must first be approved by the Health and  Disability  Ethics  Committees  (HDEC),  of  which  there  are  several  around  New  Zealand. Each  committee  is  comprised  of  medical  and  scientific  professionals,  as  well  as  lay  people with  expertise  in  other  relevant  areas  (such  as  law  or  consumer/community  perspectives). Studies  investigating  unregistered  medications  must  also  be  submitted  to  SCOTT  (Standing Committee on Therapeutic Trials) for approval. Regulatory approval for a new study may take, on average, between 1 and 3 months.

Even  after  a  study  has  been  approved,  clinical  research  sites  may  still  have  to  send  updated information about the trial to HDEC for approval. For example, there may have been a change in wording in the information sheets given to patients, or there may be a small change in how the trial is being run. These changes are made by the study sponsor, who have designed the study.

The  study  sponsor,  typically  a  research  facility  or  pharmaceutical  company,  will  usually  have several sites in New Zealand (as well as many more around the world) running a trial for their treatment, and they have designed the trial very specifically. It’s not always easy to qualify for a  trial!  Some  may  be  relatively  easy  to  enrol  in,  whereas  others  have  a  long  list  of  eligibility criteria.  P3  is  very  experienced  at  finding  the  right  study  for  people  wanting  to  help  us  with our research.

Is it safe?

At  P3,  we  only  undertake  trials  with  medications  that  have  already  been  researched  at  the initial Phase 1 stage. There are four phases of clinical research:

[highlights]Phase 1[/highlights]

is the first time in humans. These trials are designed to establish the safety of the treatment  and  the  approximate  dosing  range.  These  trials  are  performed  in healthy volunteers  and  patients are  extensively  monitored  following  treatment.  They  typically involve 20-60 people and are typically conducted within a hospital environment.

[highlights]Phase 2[/highlights]

trials  are  for  people  with  the  disease  that  the  study  medication  is  designed  to treat. Phase 2 studies typically involve 50-200 patients and may involve many assessments to look at any effects the treatment has on the body, and how the treatment is absorbed, metabolised  and  eliminated  from  the  body.  Usually  a  range  of  doses  are tried  to  look  at differences in effect and any side-effects. These studies help researchers find the best dose and dosing interval that has the desired effect.

[highlights]Phase 3[/highlights]

trials  usually  involve  very  large  numbers  of  patients  (hundreds  or  thousands)  to identify  side-effects  that  werent  seen  in  the  Phase  2  studies  and  to  find  out  more  about the  proposed  dose  and  dosing  interval.  These  studies  may  be  performed  at  out-patient clinics and can take several months (or years) to complete. P3 Research gets its name from this phase!

[highlights]Phase 4[/highlights]

trials  are  generally  conducted  after  the  product  has  reached  the  market.  These may involve hundreds or thousands of patients and see how the product is received by the general  public.  These  studies  may  help  identify  rare  side-effects that  weren’t  previously documented. These studies may be performed by GPs or other healthcare providers.

How much time is involved for the study participant?

Most studies involve visits to the unit of one to two hours each time; sometimes it’s shorter, And sometimes  it’s  longer.  Every  study  is  different.  Depending  on  the  study,  visits  may  be every day, week, month or sometimes longer. The study may last for three months, or a year, or it may last for several years.

Do patients get paid for taking part?

Every  participant  is  reimbursed  for  reasonable  traveling  and  incidental  expenses.  If  the  trial requires  a  lot of  commitment  and  time, the  study  remuneration  will often  reflect this. Every trial is different in this respect. One question some people do ask is if they have to pay us to be in a trial. The answer to that, is no, you don’t pay us!

Why would someone consider being involved in a clinical trial?

There are several reasons why people volunteer to participate. Many people are interested in their  condition  and  learning  more  about  it.  They  like  that  they  are  contributing  to  medical science and possibly improving their own health while helping to improve the health of future generations.  You  may  obtain  access  to  new  and  hopefully  better  medications  at  no  cost. Everyone on a trial receives free, regular check-ups (blood tests, breathing tests, ECG, physical examinations)  as  required  in  their  trial.  Volunteers  receive  advice  on  diet,  exercise  and managing their medication. And, of course, your condition may improve.

About P3 Research

We have three dedicated sites in the North Island: Wellington, Havelock North (Hawke’s Bay) and  Tauranga.  We  employ  dedicated,  specially  trained  and  experienced  doctors,  nurses  and other staff to care for and supervise volunteers taking part in clinical trials. We have 17 years’ experience in clinical research and have an excellent reputation nationally and internationally.

Compiled by Suzy W.
P3 Research, Wellington Unit, April 201