Safety of human research participants

In Europe, the new clinical research directives of the European Union, to be implemented by 2003, are presenting a challenge that even large academic institutions such as EORTC struggle to match. Meanwhile, changes in US law also seem imminent. The US Institute of Medicine (IOM) feels that federal oversight is needed to ensure better protection of the health and well-being of people enrolled in research studies, whether publicly or privately funded.

The IOM stated that the US Congress (which was elected on 5 November 2002) should require every organization conducting research with human subjects to do so under the authority of a research participant protection program, which would be subject to federal oversight. They did, however, add that ultimate responsibility for ensuring that the essential protections are in place and followed must rest with the highest levels of the research organization’s leadership.

Daniel Federman, senior dean for alumni relations and clinical teaching, and professor of medicine and medical education at Harvard Medical School, Boston MA, argued, "There is no single cause for the errors and mishaps that unfortunately have resulted in the deaths of some research participants in recent years. Rather, a combination of stresses, weaknesses and lack of accountability have strained the current hodgepodge of protections to the point that fundamental changes are needed to protect all participants and keep public trust from being irrevocably eroded."

Federal agencies that conduct studies on humans follow a set of principles for protecting research participants known as the ‘Common Rule’. But jurisdiction of this rule does not extend to non-federally funded research, although a bill has been proposed to make it law. Private-sector research to develop drugs, biologics or medical devices is held to similar protection standards overseen by the Food and Drug Administration (FDA). However, other privately sponsored research that is outside the FDA’s authority is not required to follow specific protection standards, although many private organizations have developed their own guidelines.

Many of the functions recommended for the protection program are currently carried out by institutional review boards (IRBs), the groups originally created by research institutions to review the ethics of proposed research involving human subjects. However, as the number of studies performed each year has increased and demands on the research oversight system have intensified, IRBs have been called on to handle an ever-wider array of tasks, including institutional risk management, regulatory compliance, evaluation of increasingly complex scientific issues, and assessments of conflicts of interest. IRBs must return to the focused role they were originally intended to serve—reviewing the ethical issues of proposed protocols—because the boards do not necessarily have the expertise, authority or resources to carry out all these additional tasks on their own.

The full text of Responsible Research: a Systems Approach to Protecting Research Participants is available free from the National Academies at http://www.nap.edu.

First ESMO cancer patient seminar

Because getting the right information for a cancer patient is a first step to recovery, ESMO (European Society for Medical Oncology) organized its first patient and family seminar on 18 October 2002, in Nice, France. Professor Heinz Ludwig, ESMO President, stated, "ESMO is confident that patients who comprehend the nature of their malignant condition, the course their disease can take, and the different options available to treat their cancer are in better control of their situation. These empowered patients can establish a real partnership with their oncologist. They suffer less from anxiety and are better able to break the stigma attached to being a cancer patient. Finally, the patient’s overall quality of life, a key to recovery, will be significantly improved." The seminar, organized jointly with the Association of European Cancer Leagues, was attended by patients and families from >20 European countries. The lively and constructive discussions proved the need for such meetings, which ESMO will now organize on a regular basis.

ESMO is active in palliative care

Dr Nathan Cherny and Professor Raphael Catane, who lead the ESMO Palliative Care Working Group, comprising of representatives from >10 member nations, reported recently that a series of definitions of supportive care, palliative care and terminal care as a frame of reference for all future discussions have been developed. This is substantial progress that will form the basis of further ESMO initiatives in this field. Policy statements to address various issues have been suggested, endorsed by ESMO’s National Representatives, and should soon be published: (i) The Role of the Oncologist in the Provision of Supportive and Palliative Care; (ii) Supportive and Palliative Care training for Medical Oncologists; and (iii) Minimal Standards for the Provision of Supportive and Palliative Care by Cancer Centers. As a basis for their work the Palliative Care Working Group carried out a survey of the ESMO membership regarding their involvement in the palliative and supportive care of patients with advanced cancer. 895 members responded. Of these, 69% reported that patients with advanced cancer constituted a major proportion of their practice, for 22% they constituted most of their practice. The survey results, presented at the 27th ESMO Congress in Nice, demonstrate a high level of consensus regarding the importance of the oncologist’s role in the provision of supportive and palliative care to dying patients and those with advanced cancer.

UK Royal College of Physicians issues new guidelines on gifts from drugs companies

Several countries have recently set limits on the relationships between pharma industry and physicians, which include sponsorship for travel to medical meetings. The authorities have rightly made continuous medical education mandatory, but provide no funding for it, and confused product launches with meetings such as the ESMO Congress, which was at risk of decreased attendance because of recent laws in some countries The UK report (Bennett J & Collins J. Clin Med 2002; 2. 320–322) was recently discussed by the BMJ (McGuaran A. BMJ 2002; 325: 511). The BMJ gave an excellent overview of the practice in many countries. Most countries have a limit on the value of outright gifts given to doctors. The French medical association authorizes limited sponsorship of attendance at scientific meetings or congresses. Spain has adopted similar rules recently. The news item in BMJ was the object of many letters. One related that of 487 doctors in Edinburgh, UK, 40% thought involvement with the industry did create a conflict of interest. When asked whether this involvement created a bias in their own drug selection 86% said that it did not.

The UK has made tremendous progress in cancer: a great result of the Europe Against Cancer programme

Peter Boyle, of the European Institute of Oncology in Milan, and Associate Editor of Annals of Oncology, said on 7 November 2002 that Britain’s attempts to prevent and cure cancer have been a success story—and not the disaster related by many other sources, including EUROCARE end results. Professor Boyle revealed that the UK is one of a handful of countries that have attained or nearly attained European targets for cutting cancer deaths. In 1985, Europe Against Cancer, an ambitious Europe-wide cancer prevention campaign was launched, which pledged member states to cut their cancer death rates by 15% by 2000. It is estimated that 90 000 deaths have been prevented during this time by the focus on tobacco control, cancer screening, education and training; but only Austria and Finland have met the 15% reduction target for both men and women. The UK and Luxembourg achieved the target for men and only narrowly missed it for women.

The 27th ESMO Congress, in Nice: also bad news

While many great achievements were announced at ESMO’s Nice meeting, some perplexing data were also discussed. (For financial reasons, the scientific data had already been disclosed by the drug company.) Principal investigators announced three negative results of the recently completed INTACT trials. These results demonstrate that ZD-1839 (Iressa), an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), does not provide improvement in survival when added to standard platinum-based chemotherapy in advanced non-small-cell lung cancer (NSCLC). The ZD-1839 once daily oral monotherapy data from the IDEAL 1 and 2 trials had shown ZD-1839 as having efficacy in the treatment of patients with advanced NSCLC.

Genentech, Inc. had previously announced that a phase III study of its vascular endothelial growth factor inhibitor bevacizumab (Avastin, rhuMAb-VEGF) in relapsed metastatic breast cancer patients did not meet its primary efficacy end point of progression-free survival. This study randomized 462 women with metastatic breast cancer who had previously received treatment with both anthracycline and taxane-based chemotherapy regimens to receive bevacizumab with capecitabine (Xeloda) or capecitabine alone. A 900-patient randomized phase III trial in colorectal cancer comparing irinotecan/5-fluorouracil/leucovorin plus bevacizumab versus without bevacizumab, will hopefully be less disappointing. The randomized phase II study in colorectal cancer, presented at the American Society of Clinical Oncology (ASCO) in 2000, suggested an increase in overall survival, time to disease progression and overall response rate in patients treated with bevacizumab in combination with chemotherapy.

Elderly can tolerate the best treatment options

Oncologists may be anxious about treating older women with breast cancer in the same way they would treat younger patients, but research conducted at the Institute Paoli Calmettes in Marseilles, France, has shown that older patients can adequately tolerate therapy. Dr Anne Chantal Braud and her team examined the effects of surgery, radiotherapy, chemotherapy and hormone therapy in 179 women over the age of 70 years. "We now know that treatment is well tolerated by patients, in contrast to our expectations", said Dr Braud. The investigations are now being expanded to include regional collaboration with 13 other hospitals, as part of a bigger program on the elderly patient with cancer. "In this network we are trying to develop a common evaluation and therapeutic approach", explained Dr Braud.





This Article
Full Text (PDF)
E-letters: Submit a response
Alert me when this article is cited
Alert me when E-letters are posted
Alert me if a correction is posted
Services
Email this article to a friend
Similar articles in this journal
Similar articles in PubMed
Alert me to new issues of the journal
Add to My Personal Archive
Download to citation manager
Disclaimer
Request Permissions
PubMed
PubMed Citation