A clinical trial refers to a medical research programme which is carried out in humans.
It's designed to answer a particular question.
Clinical trials often involve new drugs or new devices but it's also important to consider the fact that
a clinical trial might also involve the use of established medications in new ways or new combinations.
It's also possible for a clinical trial to look at using less treatment and particularly in lymphomas,
over the last few decades, there has been a move to look at eliminating therapies to try and reduce the toxicity,
or reduce the side effects, particularly in the long term for patients.
The so-called phase 1 clinical trial generally refers to a newer therapy,
which often has not been used in people before. Phase 1 clinical trials have a very strong focus upon safety.
The phase 2 clinical trial also has a very strong emphasis upon safety,
but in addition we'll also look at a greater number of parameters regarding the efficacy of a new treatment.
A phase 3 clinical trial is generally carried out in much larger numbers of people.
One has a strategy or a treatment which is generally considered to be safe
because of previous work in earlier trials.
The phase 3 clinical trial is really about trying to determine whether or not the treatment or the strategy
that is under review is better than the previously accepted standard of therapy.
For many patients, there is already a standard treatment.
Unfortunately standard treatments don't work for everyone and clinical trials will often try
and see if they can improve on the standard treatment.
We would generally have a control arm in which patients receive the standard treatment
and an experimental arm in which patients would receive an alternative treatment,
which may be the standard treatment plus something else or maybe an entirely different treatment.
We need the control arm so that we can compare and decide whether the experimental treatment is any better,
or possibly any worse, than the standard treatment.
The word 'randomisation' refers to the way in which someone is randomly allocated
to a particular treatment in a clinical trial.
This is usually carried out by a computer which uses a program
in order to randomly assign a person to a particular treatment group.
The reason why randomisation is important, is that it is essential that differences between two groups of people
who are participating in a clinical trial are minimised.
There generally two types of blinding.
The first is the so-called 'single-blinding', or a 'single-blinded' clinical trial.
This refers to the fact that the person participating in the trial is not aware of the treatment that they are receiving,
however those looking after the patient will be aware.
The 'double-blinding' or a 'double-blinded' clinical trial refers to the fact that
neither the person enrolled in the clinical trial,
nor those who are looking after them, are aware of the treatment that they have been allocated to.
This is a safe approach because those people who are caring for the person apply various measures
to ensure that people are safe and that any potential side effects on treatment are managed.
The advantage of the process of double blinding is that it eliminates or significantly reduces the chance of bias.
Generally patients are not paid to take part in a clinical trial.
The only payments patients will receive would be costs which they may have incurred,
perhaps for traveling expenses or for staying in a hotel overnight if that's necessary.
Clinical trials are funded in various ways.
The National Health Service allocates significant amounts of funding every year
for the conduct of clinical trials.
In addition, various charities invest significant sums of money to ensure clinical trials are carried out.
Pharmaceutical companies which have a new therapy or a new treatment
will also sometimes invest in clinical trials, as do university departments.
Clinical trials in Britain are regulated by the Medicines and Healthcare Products Regulatory Agency,
or the MHRA.
This body is responsible for the way in which trials are conducted.
It's important to note that the MHRA will approve all clinical trials before they commence.
The MHRA retains responsibility for the conduct of a trial after its initial approval.
The MHRA is regularly informed about the trial, they carry out regular inspections of clinical trial activity
and ensure that the trial is conducted according to an international ethical and practical standard,
called good clinical practice.