- Email: [email protected]
MULTICENTRE TRIALS IN LUNG CANCER
148 could have devised a system for administering sulphinpyrazone four times a day and aspirin every other day. It would have necessitated the use of additional placebo tablets, but it could have been accomplished. Alternatively, in appropriate circumstances, an unblinded therapist can perform the necessary dosage adjustments, while a person who is kept blind can measure and assess the outcome. Ritter rightly points out that one should not rigidly adhere to standard design features without considering other relevant factors. However, providing "highly reliable answers to inherently trivial questions" is not the inevitable result of attempting to follow sound scientific principles. Rather, when studies employing such features are feasible, they provide far stronger evidence than other designs.
National Heart, Lung, and Blood Institute,
Bethesda, Maryland 20205, U.S.A.
LAWRENCE FRIEDMAN EUGENE PASSAMANI GRAHAM MAY CURT FURBERG WILLIAM FRIEDEWALD
Compensation is always hard to evaluate, but financial compensation or help in establishing a career there must be, especially if injuries occur to patient volunteers or casual scientific labour employed to assist in short term grants. The claim outlined in your editorial is admirable. I would suggest, however, that when a project is being contemplated where volunteer subjects are being used, the ethics committee must also have the nomination of a disinterested physician who will make sure that all subjects are in fact suitable and supervise their aftercare. Many of the mistakes that are made with experiments stem in part from the belief that, because the subjects are medically qualified and because the person in charge is also participating in the experiments, stupid clinical mistakes will be avoided. Wolfson Gastrointestinal Laboratories, Western General Hospital, Edinburgh EH4 2XU
MARTIN EASTWOOD
DRUG EMERGENCIES AND THE PHARMACIST
SIR,-For MULTICENTRE TRIALS IN LUNG CANCER
SIR,-We were encouraged by your June 21 editorial in which you suggest that trials of therapy in lung cancer should be undertaken on a multicentre basis in the U.K. We fully agree that inadequate trials are valueless, and over the past two years we have developed a multicentre lung cancer study group which has been running trials of the kind you suggest. An enthusiastic group of consultants from a few hospitals which together treat a large number of cases of lung cancer. has several advantages for the organisation of trials in cancer. The accrual of patients is high enough, but bureaucracy can be kept to a bare minimum, unlike national studies. Because the treatment is supervised by only a few consultants deviation from the protocol treatment is rare. Furthermore rather more radical treatments can be tried as experience grows, while in national studies treatment has to be acceptable to physicians of varying experience. Our group covers four large hospitals and we run our studies with one research coordinator, a nurse. Our current study into small-cell carcioma of the bronchus has a case accrual of about 15 patients every month, permitting a large study to be completed over a two year period. We are also supervising studies in non-small-cell lung cancer. We would urge other chest physicians (surprisingly omitted from your suggested team), radiotherapists, and medical oncologists to consider forming study groups of this kind; we find it rewarding to study patients as well as simply to treat them. In addition, large controlled trials are essential since smaller uncontrolled pilot studies often make inflated claims which are subsequently shown to be unjustified, especially in lung cancer.
.
Royal Marsden Hospital, London SW3
J. S. TOBIAS
University College Hospital,
R. L. SOUHAMI P. G. HARPER
London WC 1
Brompton Hospital, London SW3
S. G. SPIRO
London Chest Hospital
D. M. GEDDES
INJURIES
.
IN RESEARCH
SIR,-I read with interest your June 28 editorial on compensation for volunteers injured during experiments. I would like to comment on this with the experience of a failed transintestinal intubation experiment, resulting in two laparotomies and several obstructive episodes. I have also-been a member of our local ethics of research committee.
a
display of
American medical letter (May 17, p.
what
most
is wrong with North
practice today Mr Pelter and Dr McGhan’s
1086) is hard to beat. Pharmacists dispense patients who bring prescriptions which have been written for them by their physicians. A reasonably literate per-
drugs
to
who is honest can fulfil all the duties and responsibilities modern pharmacist. Pharmacists who study "pathology, histology, microbiology, physiology ... clinical therapeutics and so on" are wasting their time and taxpayers’ money. We are bedevilled with a host of ancillary personnel who have been exposed to the fascinations of basic medical disciplines and who are in consequence dissatisfied with their roles and search for new ones. No power without responsibility. The ultimate responsibility for any patient lies with his physician. There is no need for and there is positive danger in diluting the direct contact between physicians and their patients. There is no justification, logic, or good medical practice in this profusion of socalled paramedical personnel who would convince us of their importance by their earnest recital of their basic scientific and "clinical" training.
son
of
a
of Anæsthesia, Koerner Acute Care Unit, Health Sciences Centre Hospital,
Department
Vancouver, Canada; and Departments of Anæsthesia and Pharmacology, University of British Columbia
KENNETH M. LEIGHTON
AUTHORSHIP OF ARTICLE ON PRIMARY
HYPERPARATHYROIDISM IN LANCET OF JUNE 21
SIR,-It is always sad to see colleagues in dispute. The letpublished (July 5, p. 30) are a further reminder, if any were needed, that tighter procedures should be adopted to ensure that all parties involved in a publication are treated
ters you
a comment from an interested observer from the sidelines is warranted. I, and I believe my colleagues in the other clinical chemistry departments involved, first heard about the project of hypercalcaemia from Dr Heath, before Dr Mundy had arrived in the hospital. He outlined what he proposed to do, and took great pains, as indeed has been his repeated practice, to ensure that the laboratories knew what was going on so that the fullest cooperation could be achieved; on Dr Mundy’s own criteria ("substantive contributions in terms of experimental design ...") I think Dr Heath was fully entitled to co-authorship. The Lancet would seem to be lax in allowing the name of a
fairly. Perhaps
National Heart, Lung, and Blood Institute,
Bethesda, Maryland 20205, U.S.A.
LAWRENCE FRIEDMAN EUGENE PASSAMANI GRAHAM MAY CURT FURBERG WILLIAM FRIEDEWALD
Compensation is always hard to evaluate, but financial compensation or help in establishing a career there must be, especially if injuries occur to patient volunteers or casual scientific labour employed to assist in short term grants. The claim outlined in your editorial is admirable. I would suggest, however, that when a project is being contemplated where volunteer subjects are being used, the ethics committee must also have the nomination of a disinterested physician who will make sure that all subjects are in fact suitable and supervise their aftercare. Many of the mistakes that are made with experiments stem in part from the belief that, because the subjects are medically qualified and because the person in charge is also participating in the experiments, stupid clinical mistakes will be avoided. Wolfson Gastrointestinal Laboratories, Western General Hospital, Edinburgh EH4 2XU
MARTIN EASTWOOD
DRUG EMERGENCIES AND THE PHARMACIST
SIR,-For MULTICENTRE TRIALS IN LUNG CANCER
SIR,-We were encouraged by your June 21 editorial in which you suggest that trials of therapy in lung cancer should be undertaken on a multicentre basis in the U.K. We fully agree that inadequate trials are valueless, and over the past two years we have developed a multicentre lung cancer study group which has been running trials of the kind you suggest. An enthusiastic group of consultants from a few hospitals which together treat a large number of cases of lung cancer. has several advantages for the organisation of trials in cancer. The accrual of patients is high enough, but bureaucracy can be kept to a bare minimum, unlike national studies. Because the treatment is supervised by only a few consultants deviation from the protocol treatment is rare. Furthermore rather more radical treatments can be tried as experience grows, while in national studies treatment has to be acceptable to physicians of varying experience. Our group covers four large hospitals and we run our studies with one research coordinator, a nurse. Our current study into small-cell carcioma of the bronchus has a case accrual of about 15 patients every month, permitting a large study to be completed over a two year period. We are also supervising studies in non-small-cell lung cancer. We would urge other chest physicians (surprisingly omitted from your suggested team), radiotherapists, and medical oncologists to consider forming study groups of this kind; we find it rewarding to study patients as well as simply to treat them. In addition, large controlled trials are essential since smaller uncontrolled pilot studies often make inflated claims which are subsequently shown to be unjustified, especially in lung cancer.
.
Royal Marsden Hospital, London SW3
J. S. TOBIAS
University College Hospital,
R. L. SOUHAMI P. G. HARPER
London WC 1
Brompton Hospital, London SW3
S. G. SPIRO
London Chest Hospital
D. M. GEDDES
INJURIES
.
IN RESEARCH
SIR,-I read with interest your June 28 editorial on compensation for volunteers injured during experiments. I would like to comment on this with the experience of a failed transintestinal intubation experiment, resulting in two laparotomies and several obstructive episodes. I have also-been a member of our local ethics of research committee.
a
display of
American medical letter (May 17, p.
what
most
is wrong with North
practice today Mr Pelter and Dr McGhan’s
1086) is hard to beat. Pharmacists dispense patients who bring prescriptions which have been written for them by their physicians. A reasonably literate per-
drugs
to
who is honest can fulfil all the duties and responsibilities modern pharmacist. Pharmacists who study "pathology, histology, microbiology, physiology ... clinical therapeutics and so on" are wasting their time and taxpayers’ money. We are bedevilled with a host of ancillary personnel who have been exposed to the fascinations of basic medical disciplines and who are in consequence dissatisfied with their roles and search for new ones. No power without responsibility. The ultimate responsibility for any patient lies with his physician. There is no need for and there is positive danger in diluting the direct contact between physicians and their patients. There is no justification, logic, or good medical practice in this profusion of socalled paramedical personnel who would convince us of their importance by their earnest recital of their basic scientific and "clinical" training.
son
of
a
of Anæsthesia, Koerner Acute Care Unit, Health Sciences Centre Hospital,
Department
Vancouver, Canada; and Departments of Anæsthesia and Pharmacology, University of British Columbia
KENNETH M. LEIGHTON
AUTHORSHIP OF ARTICLE ON PRIMARY
HYPERPARATHYROIDISM IN LANCET OF JUNE 21
SIR,-It is always sad to see colleagues in dispute. The letpublished (July 5, p. 30) are a further reminder, if any were needed, that tighter procedures should be adopted to ensure that all parties involved in a publication are treated
ters you
a comment from an interested observer from the sidelines is warranted. I, and I believe my colleagues in the other clinical chemistry departments involved, first heard about the project of hypercalcaemia from Dr Heath, before Dr Mundy had arrived in the hospital. He outlined what he proposed to do, and took great pains, as indeed has been his repeated practice, to ensure that the laboratories knew what was going on so that the fullest cooperation could be achieved; on Dr Mundy’s own criteria ("substantive contributions in terms of experimental design ...") I think Dr Heath was fully entitled to co-authorship. The Lancet would seem to be lax in allowing the name of a
fairly. Perhaps