Obtaining archived pathological material for biomedical research

Basu, Saurajyoti; Martin, Sandie W.; Phillips, Roger M.; Puri, Rajiv

doi:10.1016/s0140-6736(03)13069-3

Cited by 6 publications

(6 citation statements)

References 2 publications

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“…Yet, paradoxically, their templates for providing patients with information can result in inappropriate, lengthy and unclear information leaflets. 7 And there are many examples of the same protocol being approved by one ethics committee but not another, 9,10 or being turned down for completely different reasons. There are even variations in the requirement for an ethics submission to be made at all, perhaps because the line between audit (no ethics approval generally required) and research (ethics approval required) is so blurred.…”

Section: Research Ethics Regulationsmentioning

confidence: 99%

Over-regulation of clinical research: a threat to public health

Warlow

2005

Clinical Medicine

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-Clinical research is subject to increasing regulation by research ethics committees and research and development offices which are responding to social and political pressures, as well as to new legislation, both European and national, some of which is still being worked out. The resulting bureaucracy, expense and confusion are putting insuperable hurdles in the way of clinical research and clinical care is compromised. What research is still possible will only be done in large organisations and may even be seriously biased. The solutions are to inform and seek the help of the public and to forge alliances with patient groups. Patients have far more to lose than clinical researchers who, if clinically qualified, can more easily pursue a fulfilling career as clinicians rather than researchers.

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Section: Research Ethics Regulationsmentioning

confidence: 99%

Over-regulation of clinical research: a threat to public health

Warlow

2005

Clinical Medicine

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“…While translational research offers exciting possibilities for clinical advances in the field of breast cancer, gaining patient consent to study tissue specimens is an important consideration [23][24][25]. Tissues removed for a diagnostic or therapeutic procedure were traditionally regarded as 'abandoned,' implying that patient consent would not be necessary for further study, but more recently, these specimens are being perceived as a 'gift' that requires specific patient consent for them to be used in future research [23].…”

Section: Conclusion and Implications For Future Researchmentioning

confidence: 99%

“…However, obtaining patient consent prospectively for studying biomarkers may be difficult, as new markers may be identified after a clinical trial has begun [24]. Obtaining patient consent retrospectively may also be challenging if tissue samples were provided years earlier, and local research and ethics committees themselves may disagree on whether obtaining patient consent is necessary in specific situations [25]. This is particularly challenging for international trials such as ATAC, for which centers are based in 21 countries.…”

Section: Conclusion and Implications For Future Researchmentioning

confidence: 99%

Biomarker investigations from the ATAC trial: the role of TA01

Dowsett

2004

Breast Cancer Res Treat

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cDNA arrays and proteomic analyses have allowed the rapid identification of specific genes and proteins implicated in multiple tumor types. These molecules must then be validated as clinically relevant prognostic and predictive markers, and this translational research is best conducted in the context of clinical trials. Outcomes data and clinical specimens collected in the 'Arimidex', Tamoxifen, Alone or in Combination (ATAC) study, for example, can now be used to compare the expression of biomarkers with clinical outcomes. In this study, adjuvant tamoxifen and anastrozole ('Arimidex') were compared alone and in combination in more than 9000 women with breast cancer. Anastrozole was found to be superior to tamoxifen in terms of disease-free survival, time to recurrence, and reduction in the incidence of contralateral tumors. Importantly, tissue specimens from surgical excision, local relapse, and contralateral breast cancer were collected and paraffin-embedded for storage. In the TA01 (TransATAC) program, these specimens will be studied (after obtaining patient consent) using tissue microarrays; tissue biopsy cores 0.6 mm in diameter will be removed from donor blocks and placed on recipient blocks, which will be sectioned to allow the simultaneous analysis of the same samples for multiple biomarkers. These analyses can help determine differential benefits of treatment with anastrozole or tamoxifen, depending on the expression of particular biomarkers in tumor cells. This research also should clarify de novo and acquired resistance mechanisms, and the validation of relevant molecular pathways could guide the development of new drugs. Ultimately, the TA01 program has the potential to favorably impact treatment choices for breast cancer.

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“…Concentrating on trivia which have little bearing on the conduct of research may also frustrate patients waiting to take part in trials. Numerous instances have been quoted by researchers where a protocol approved by one EC has been turned down by another for completely different reasons [6,7]. ECs should function efficiently, expeditiously and professionally and be less concerned with trivia, as delays can cost lives [6].…”

Section: International Collaborative Clinical Research: Advantages Armentioning

confidence: 99%

International collaborative clinical research: advantages are many, but we need to be cautious

Amarasekera

2013

Ceylon Med. J.

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Obtaining archived pathological material for biomedical research

Cited by 6 publications

References 2 publications

Over-regulation of clinical research: a threat to public health

Over-regulation of clinical research: a threat to public health

Biomarker investigations from the ATAC trial: the role of TA01

International collaborative clinical research: advantages are many, but we need to be cautious

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