How Safe is the Recruitment Process For Clinical Trials?
It isn't just animal testing that allows a new medicine to be sold or prescribed to the public.
Many medicines (drugs), never even get through the system owing to the strict laws surrounding the second phase of research, namely, testing in healthy HUMAN volunteers.
Pharmaceutical companies invest on average £500 million on every new drug developed from conception to getting the 'piggy to market'.
Whilst the public may have been aware of animal and patient trials (studies), few people were aware of the Healthy Human Volunteer Studies.
That is - until one went wrong several years ago.
The five stages of recruitment for these healthy volunteers are extremely tedious.
They are done mostly for the safety of each volunteer and to satisfy the MHRA regulations.
Volunteers who complete a study can receive hundreds or even thousands of pounds in remuneration.
This fact can sometimes entice people to withhold information and put their health at risk.
The Drug Company is responsible for making it as safe as possible for every volunteer who tests a new medicine.
Strict advertising laws prevent the public from being coerced into volunteering.
Initial advertising is done to attract people as 'volunteers' and the subject of money is prohibited.
Once a candidate volunteer shows any interest, an array of exclusion criteria prevent even the most likely person from getting through the first visit.
A personal meeting is arranged and initial height, weight and BP checks are performed.
As much information is given as possible.
A full medical history is taken from the volunteer.
Even a history of allergy, drugs of abuse or strong medication can end the recruitment abruptly.
The GP/doctor is paid to reveal all previous and present medical information since birth.
He or she can advise against the volunteer's participation without giving any justification.
When the volunteer wishes to join a particular study, more exclusion criteria sift out the few from the hundreds on the database.
Eligible volunteers are mailed giving out study details without mentioning their remuneration.
They must then attend a full medical and pass all of the tests.
This includes, BMI, BP, urinalysis, blood tests, and ECG and a full physical examination by a doctor.
Any slight deviation from the study criteria will deselect the volunteer.
A small percentage payment will be made for their participation.
After a week, the volunteers come back for a consent visit where they are told all the negative reports from the animal testing phase along with any anticipated side effects from the new study drug.
They sign a consent form declaring they understand the risks but can withdraw at any time.
Some studies last three months.
Finally, before the study begins, a restriction period takes place for scientific reasons.
This may include: not eating various foods, caffeine, and alcohol or do extra exercise for days or weeks.
The day before, they undergo another full medical and are required to pass all the tests once again.
So in all, the recruitment process means that an awful lot of 'piggies stay at home' and never get anywhere near the market.
Many medicines (drugs), never even get through the system owing to the strict laws surrounding the second phase of research, namely, testing in healthy HUMAN volunteers.
Pharmaceutical companies invest on average £500 million on every new drug developed from conception to getting the 'piggy to market'.
Whilst the public may have been aware of animal and patient trials (studies), few people were aware of the Healthy Human Volunteer Studies.
That is - until one went wrong several years ago.
The five stages of recruitment for these healthy volunteers are extremely tedious.
They are done mostly for the safety of each volunteer and to satisfy the MHRA regulations.
Volunteers who complete a study can receive hundreds or even thousands of pounds in remuneration.
This fact can sometimes entice people to withhold information and put their health at risk.
The Drug Company is responsible for making it as safe as possible for every volunteer who tests a new medicine.
Strict advertising laws prevent the public from being coerced into volunteering.
Initial advertising is done to attract people as 'volunteers' and the subject of money is prohibited.
Once a candidate volunteer shows any interest, an array of exclusion criteria prevent even the most likely person from getting through the first visit.
A personal meeting is arranged and initial height, weight and BP checks are performed.
As much information is given as possible.
A full medical history is taken from the volunteer.
Even a history of allergy, drugs of abuse or strong medication can end the recruitment abruptly.
The GP/doctor is paid to reveal all previous and present medical information since birth.
He or she can advise against the volunteer's participation without giving any justification.
When the volunteer wishes to join a particular study, more exclusion criteria sift out the few from the hundreds on the database.
Eligible volunteers are mailed giving out study details without mentioning their remuneration.
They must then attend a full medical and pass all of the tests.
This includes, BMI, BP, urinalysis, blood tests, and ECG and a full physical examination by a doctor.
Any slight deviation from the study criteria will deselect the volunteer.
A small percentage payment will be made for their participation.
After a week, the volunteers come back for a consent visit where they are told all the negative reports from the animal testing phase along with any anticipated side effects from the new study drug.
They sign a consent form declaring they understand the risks but can withdraw at any time.
Some studies last three months.
Finally, before the study begins, a restriction period takes place for scientific reasons.
This may include: not eating various foods, caffeine, and alcohol or do extra exercise for days or weeks.
The day before, they undergo another full medical and are required to pass all the tests once again.
So in all, the recruitment process means that an awful lot of 'piggies stay at home' and never get anywhere near the market.
