快猫短视频

ADVERTISEMENTS for clinical research associates (CRAs) regularly appear in
this magazine. The nomenclature varies. Some organisations seek to recruit
clinical research scientists, and occasionally clinical research monitors and
so-called 鈥渟tudy site coordinators鈥�. What do they do? What skills and knowledge
do they require? Could you do it?

Clinical researchers are either employed by pharmaceuticals firms or by
contract research organisations which carry out clinical trials on behalf of
pharmaceuticals companies. Some are employed by contractors but seconded to a
pharmaceuticals company for the period of a trial. Some are 鈥渇ield based鈥�
working from home, while others are 鈥渋n house鈥� and have offices within their
organisations.

According to the Association of Independent Clinical Research Contractors,
Leicester, there are around 100 clinical research contracting organisations in
Britain. Quintiles, Bracknell, and Covance, Maidenhead, are the largest of them,
each employing more than 5000 people. Smaller organisations employing hundreds,
rather than thousands of staff include Clinpharm, Maidenhead, Invaresk Research,
Tranent in Scotland, and SMS, Crowthorne.

The work is entirely concerned with the process of ensuring that all new
drugs are safe and efficacious to use. Of course, all drugs are toxic and have
unwanted side effects. Before they come to the market they must pass the most
stringent of trials. Clinical research associates are responsible for the
design, organisation and administration of those trials. Around 3000 people in
Britain who do this job are members of the Association for Clinical Research in
the Pharmaceuticals Industry (ACRPI).

Prospective drugs must pass through four phases of clinical trials. The first
phase is the testing of the drug compound on healthy individuals. These trials
are concerned with safety and the kinetics of what happens to the drug once it
is in the body.

The second phase involves studying what occurs when the drug is tested on a
few volunteers who have the disease that the drug is designed to alleviate. A
number of important questions are raised at this stage: Does the drug have a
positive effect? Is it safe? What is the optimum dose? What happens when the
drug is broken down within the human body into other compounds?

If a drug has passed the first two stages successfully it moves onto the
third phase of clinical trials. Now a large number of patients become involved.
Some of these patients are unaware that they have been given a placebo, or even
a competitor drug, so that the effects of the new compound can be directly
compared with those of a placebo or other drugs. If all goes well in these
trials the drug will receive a licence and the pharmaceuticals company will
begin to market it widely to be taken by sufferers from a particular
ailment.

The fourth stage of clinical trials occurs once the drug has become widely
available. These studies include a much larger number and wider range of
patients.

People recruited into a career as a clinical researcher usually have a degree
in the life sciences or a nursing qualification. Starting salaries are in the
range 拢14 000 to 拢16 000 a year while clinical research managers
earn in excess of 拢40 000.

The first step is to become a clinical research monitor. 鈥淣ew recruits
receive two or three days of training, particularly to learn what we mean by
`good clinical practice鈥欌�攖he guidelines for how a clinical trial should be
conducted,鈥� says Jo Renold a physiology graduate and a CRA at Clinpharm. 鈥淭hen
they learn on the job , through shadowing experienced research associates. When
I begin a new trial in a treatment area I have not experienced before, there is
a sharp learning curve and it is essential to learn about the disease and its
diagnosis from the clinical experts in the field. We also discover what is
relevant from reading the literature.鈥�

Centres where clinical trials are conducted include hospitals and GPs鈥�
surgeries. Large hospitals, which are usually involved in several trials, have
study site coordinators, often but not always nurses, with whom the clinical
research monitors liaise.

鈥淎s a senior CRA, I spend three days each week visiting trial sites and two
in the office organising the paper work,鈥� says Hazel Dunderdale, a PhD
biochemist also from Clinpharm. 鈥淭he sites can be all over Britain. Some
companies `regionalise鈥� their clinical research associates to minimise the
travel involved, others don鈥檛. We all need a driving licence and a company car
comes automatically with the job,鈥� added Dunderdale.

Placebos and competitor drugs are often used for direct comparison in the
trials. Studies are often 鈥渂lind鈥� so that neither the patient, nor the clinician
responsible for the testing, nor the CRA organising the trials knows which
patient received which medication. Only the originator of the trial has this
knowledge and any bias in the results is thereby eliminated.

鈥淎 typical research centre will recruit between 5 and 30 patients to be
involved in the study,鈥� says Dunderdale. 鈥淚 have to check that the strict
protocols are observed, that the patients are eligible for the trial and have
agreed in writing to participate. Every four to six weeks I visit the centre,
check and collect the data, and check the hospital pharmacy records to make sure
that each patient has received the right preparation,鈥� she says.

At the senior level the job involves applying to hospital ethics committees
for permission to conduct the clinical trials and to have specific medical staff
involved. It includes the writing of protocols, applying for and obtaining the
licences for each trial. Project managers supervise the work of five or six CRAs
and may have other responsibilities, including data management.

The ACRPI recently set up its own professional qualifications in
collaboration with Liverpool John Moores University (LJMU). Twelve study modules
are available. The association and LJMU award a clinical research certificate in
professional development on completion of four modules, a postgraduate
certificate in clinical research on completion of six compulsory modules, a
diploma after eight and a Master鈥檚 Degree in Clinical Research on completion of
the whole course including a project.

So what skills are required for success? 鈥淭o enjoy this job you need people
skills,鈥� says Dunderdale. 鈥淵ou have to communicate with a lot of people
including clinical consultants and nursing staff. Being an extrovert helps. CRAs
have to be well organised and have an eye for detail. Some of the checking is
quite repetitive so it is important to be consistent and concise. Finally, you
have to be independent and organise your own time. It is not a job in which your
supervisor is constantly looking over your shoulder,鈥� she comments.