Ethics In Human Drug Trials: A Literature Review

Broad Scan

This paper focuses on literature review on the topic of health science, “ethics in human drug trials (pharmacological research)”. The paper would focus on review of two papers that are relevant to the concerned research area. The first article is on the effect of study type on research ethics committee’s queries related to medical studies. The second article has the emphasis on the ethical and health consequences of outsourcing clinical trials to other countries. An outline of the literature review chapter is provided in the consecutive section. The content of the introduction to be included in the literature review chapter is written in the next section.

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Broad scan

In broad scan I chose my topic and carried out an extensive search on the internet with the relevant keywords. The online platforms were the search was carried out were Google Scholar, VU library and IEEE. A number of papers were selected that were assessed in the next level.

Research journal

Date

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Task

Action

Comment

08.05.18

Search on the topic

Selected few topics

One topic was considered

09.05.18

Finding papers on different online sources

Review the papers

Save the papers for later review

10.05.18

Literature reading

Read three papers

Good topic

11.05.18

Literature reading

Read three papers

Not related topic

12.05.18

Select the three documents

Read them consecutively

Two papers selected for review

14.05.18

Start writing assignment

Citation of sources done

Citations inserted

15.05.18

Review of first paper

Read the paper twice  

Good understanding of the paper

17.05.18

Review of second paper

Read the paper twice  

Good understanding of the paper

18.05.18

Writing assignment

Written both the paper reviews

Preparation done

Source

Keyword use

No of literature retrieved

No of collected literature

Scholar

Ethics, ethics, ethical, clinical trial, trial, pharmacological trial, human trial, medical, research, study

1254

6

VU library

Ethics, ethics, ethical, clinical trial, trial, pharmacological trial, human trial, medical, research, study

2358

7

IEEE

Ethics, ethics, ethical, clinical trial, trial, pharmacological trial, human trial, medical, research, study

1987

4

Bibliographic file from broad scan

Azizi, F. (2016). Ethics in clinical research. Medical Ethics Journal, 2(3), 33-48.

Belhekar, M. N., Bhalerao, S. S., & Munshi, R. P. (2014). Ethics reporting practices in clinical research publications: A review of four Indian journals. Perspectives in clinical research, 5(3), 129.

Blümle, A., Meerpohl, J. J., Schumacher, M., & von Elm, E. (2016). Fate of clinical research studies after ethical approval—follow-up of study protocols until publication. In Ethics and Governance of Biomedical Research (pp. 109-123). Springer, Cham.

Brassington, I. (2017). The ethics of reporting all the results of clinical trials. British medical bulletin, 121(1), 19-29.

Christakis, N. A. (1992). Ethics are local: engaging cross-cultural variation in the ethics for clinical research. Social science & medicine, 35(9), 1079-1091.

Fakruddin, M., Chowdhury, A., Hossain, M. N., & Mannan, K. S. B. (2012). Ethics in clinical research. Bangladesh Journal of Bioethics, 3(3), 16-20.

Garattini, S. (2009). Ethics in clinical research. Journal of Hepatology, 51(4), 792-797.

Guraya, S. Y., London, N. J. M., & Guraya, S. S. (2014). Ethics in medical research. Journal of Microscopy and Ultrastructure, 2(3), 121-126.

Happo, S.M., Halkoaho, A., Lehto, S.M. and Keränen, T., 2017. The effect of study type on research ethics committees’ queries in medical studies. Research Ethics, 13(3-4), pp.115-127.

Hey, S. P., Weijer, C., Taljaard, M., & Kesselheim, A. S. (2018). Research ethics for emerging trial designs: does equipoise need to adapt?. BMJ: British Medical Journal (Online), 360.

Homedes, N. and Ugalde, A., 2016. Health and ethical consequences of outsourcing pivotal clinical trials to Latin America: A cross-sectional, descriptive study. PloS one, 11(6), p.e0157756.

Research Journal

Larkin, M. E., Beardslee, B., Cagliero, E., Griffith, C. A., Milaszewski, K., Mugford, M. T., … & Witte, E. R. (2017). Ethical challenges experienced by clinical research nurses: A qualitative study. Nursing ethics, 0969733017693441.

Li, R. H., Wacholtz, M. C., Barnes, M., Boggs, L., Callery-D’Amico, S., Davis, A., … & Lynch, H. F. (2016). Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees. Journal of medical ethics, 42(4), 229-234.

Miller, F. G., & Brody, H. (2007). Clinical equipoise and the incoherence of research ethics. The Journal of medicine and philosophy, 32(2), 151-165.

Ravinetto, R., Guenzi, P. D., Massat, P., & Gaidano, G. (2014). Globalisation of clinical trials and ethics of benefit sharing. The Lancet Haematology, 1(2), e54-e56.

Rid, A. (2018). Individual and public interests in clinical research during epidemics: a reply to Calain: In response to: Calain P. The Ebola clinical trials: a precedent for research ethics in disasters. Journal of medical ethics, 44(1), 11-12.

Silverman, H. (2007). Ethical issues during the conduct of clinical trials. Proceedings of the American Thoracic Society, 4(2), 180-184.

After filtering the papers I selected for my further writing. Out of the papers I selected two papers for final writing.

Updated filling system

Source

Keyword used

No of literature retrieved

No  of literature collected

Scholar

Ethics, ethics, ethical, clinical trial, trial, pharmacological trial, human trial, medical, research, study

325

3

VU library

Ethics, ethics, ethical, clinical trial, trial, pharmacological trial, human trial, medical, research, study

214

4

IEEE

Ethics, ethics, ethical, clinical trial, trial, pharmacological trial, human trial, medical, research, study

123

1

Bibliographic file from focused review

Coultas, D. (2007). Ethical considerations in the interpretation and communication of clinical trial results. Proceedings of the American Thoracic Society, 4(2), 194-199.

Glickman, S. W., McHutchison, J. G., Peterson, E. D., Cairns, C. B., Harrington, R. A., Califf, R. M., & Schulman, K. A. (2009). Ethical and scientific implications of the globalization of clinical research.

Happo, S.M., Halkoaho, A., Lehto, S.M. and Keränen, T., 2017. The effect of study type on research ethics committees’ queries in medical studies. Research Ethics, 13(3-4), pp.115-127.

Homedes, N. and Ugalde, A., 2016. Health and ethical consequences of outsourcing pivotal clinical trials to Latin America: A cross-sectional, descriptive study. PloS one, 11(6), p.e0157756.

Miller, F. G., & Brody, H. (2007). Clinical equipoise and the incoherence of research ethics. The Journal of medicine and philosophy, 32(2), 151-165.

Network, S. A. C. (2008). Clinical trials in India: ethical concerns. Bulletin of the World Health Organization, 86(8).

Saenz, C., Reveiz, L., & Tisdale, J. F. (2015). Public titles of clinical trials should have ethics review. Journal of clinical epidemiology, 68(9), 1105-1107.

Happo et al. (2017) had the focus on studying the impact of type of research on the queries raised by research ethics committee in relation to medical studies. The authors were successful in providing a concrete background to the study undertaken. All medical research involving human subjects are to undergo evaluation undertaken by an existing research ethics committee (REC) before the study is undertaken. The primary objective of the REC is to make sure that the ethical and scientific validity of the research is persistent. Further, the RECs are supposed to ensure that the research is carried out as per the suitable national regulations and legislations. Nevertheless, there is a limitation of knowledge regarding the decision processes of REC in regards to evaluation of risk-benefit balance in different study types. The authors mentioned that previous studies in the concerned matter did not consider an examination of the potential risk factors affecting the evaluation process of the REC. It was therefore thought desirable to carry out a quantitative evaluation of the forms of queries related to study protocols. The aim was determination of whether studies having more invasive nature and therefore having more risky procedures were subjected to more queries.

Bibliographic File from Broad Scan

The records and study protocols of a Finland university hospital REC were considered for survey for 5 years. The study procedures in each study plan underwent examination, and the classification of studies was done into groups of clinical drug trials, clinical trials with medical devices, studies with invasive interventions and studies with noninvasive physical processes. Manual extraction of data was considered for the records. As opined by Panneerselvam (2014) manual extraction of data brings in the chance of errors in data collection. An inclusion criterion was set for considering the papers for present study. In clinical drug trials, the REC had the predisposition to pose queries more often. Such queries were related to risk-benefit ratio, study methods. Certain queries were also raised in relation to participant features. It was inferred that the focus on risk-benefit evaluation in clinical drug trials emerge from the concern that such trials are common conducted on individuals and the chances of entry of novice chemical entities into the human body is more. The constraints in method queries with regards to clinical trials might imply high quality of research with are sponsored by industry.

The paper had certain strengths and limitations which are important. The dataset was representation of one particular REC. This decreases the generalisabiltiy of the study, means the study findings might not be applicable to other settings (Flick 2014). The study had the focus on concerns pertaining to study protocols instead of materialistic elements. Further, RECs do show variations in their decisions. A key strength of the study was that a comprehensive evaluation of the study protocols of one REC was carried out by the researchers, and outcomes for different study types were considered.

Homedes and Ugalde (2016) carried out a research for understanding the ethical and health considerations of outsourcing significant clinical trials to Latin America. There lies a dearth of studies that evaluate the implications of conducting clinical trials in middle and low income countries in the safety and financial accessibility of the pharmaceutical products in the respective markets, as pointed out by the researchers. As the background of the study the researchers mentioned that the trend in outsourcing clinical trials is a matter of ethical concern. There has been limited scrutiny of the impact of clinical trials in relation to safe and appropriate use of new pharmacy drugs. The health consequences of outsourcing the clinical trials have not been considered by many researchers. Commercialization of pharmaceutical products has therefore been linked to economic benefits. Against this background, the research carried out the present study understand the health benefits, and thus the ethical benefits, of the clinical trials implemented in Latin America for the country’s population as a whole.

Focused Review

The study design was a cross-sectional descriptive one. The advantage of such studies is that it is cheaper to perform and does not entail much time for completion of the study. Further, such studies capture a particular point in time. The data collected can also be used for different forms of research (Flick 2015). However, the disadvantage of such study is that cause and effect cannot be determined. Findings can also have flaws under certain conditions (Panneerselvam 2014).  The study considered consulting two databases that were highly reputed. The first objective was to determine the safety profile and therapeutic value of the New Molecular Entities (NMEs) approved by the Food and Drug Administration (FDA) in 2011 and 2012 that were tested in Latin America in the year 2012 and 2013. The second objective was to understand the implications of the respective market approval for the country’s pharmaceutical budgets. 

It was found at the end of the study that 33 NMEs were tested in Latin America that was approved by FDA in 2011 and 2012. Out of these evaluations of 26 NMEs were done by drug bulletins functioning independently. The study further reported that the pharmaceutical prices were considerably high, and had variations across countries. Moreover, these had no relation with the minimum wage or income per capita of the country. The conclusion of the study was that clinical trial implementation leads to the commercialization of numerous medicines that has uncertain and open to discussion safety profile. In addition, the therapeutic value is also limited. Patients are therefore out at risk of harm and budgetary strains are also a matter of concern.

The present study though was valuable, had certain limitations that are to be mentioned. Though the FDA reviews considered including trials with NMEs, there was no specification related to which trial was considered for approving the NME. This led to inclusion of lesser number of countries. The second limitation was that the countries that were considered for evaluation were inequitable. This has the ability to make the assessment inaccurate (Friedman et al. 2015).

Conclusion

Ethical implications of human clinical trials have a key focus on queries arising in relation to risk and harm, and health benefits. This is related to the notion that clinical drug trials are conducted in individuals who have new entities entering their bodies eventually. Limited data on the safety of the drugs make the concern noteworthy. Queries are often not addressed adequately in practice as there are issues related to study methods and participation of individuals. Queries related to non physical procedures are also there but these are less severe in extent. Discussion regarding ethics of clinical trial outsourcing is also noteworthy. From the above literature review it can be concluded that safety of human beings is the prime concern arising from the outsourcing of clinical trials to other countries. It is recommended that the contributory factors for outsourcing are to be analyzed in depth in future. Further studies are to have more rigorous study methodology. This would ensure that the validity of the research papers is high and the study findings are applicable to a wider population.

Bibliographic File from Focused Review

A literature review is a scholarly paper that includes present knowledge on a certain topic of interest encompassing substantive findings. Literature reviews are important sources of rich information that contributed to enhancement of knowledge. It has been repeatedly pointed out that assessment of a certain topic is best carried out through a literature review (Flick 2015). The topic for the present literature review is ethics in human drug trials (pharmacological research). It was thought obvious to carry out the literature review to gain maximal knowledge on the concerned topic. A search of relevant information source helped in determination of what is known about the topic and the degree to which the topic has been searched about. The two most relevant papers discussed had the focus on queries in clinical trial research and ethical consequences of outsourcing clinical trials. The benefit of considering these papers was that they revealed significantly the extent to which the topic has been written about in recent times. Identification of important issues and questions about the topic requiring further research was also possible.

The objective of clinical research, mainly pharmacological trials with participation of humans, is to bring in a development in the knowledge pool of pharmacology that is responsible for improving the health conditions of population in general. Individuals who take part in the research ensure that knowledge is secured effectively (Rosenberger and Lachin 2015). The way of finding something novice and effective in drug fraternity entails trial on humans. When the individuals are involved in drug trials, there harm and risk of hazards are to be adequately judged. The ethical considerations are placed to protect the lives of humans along with preserving the integrity of pharmacological science. A prime area of research at present is outsourcing of clinical trials (Califf and Sugarman 2015). The recent and dramatic proliferation of pharmaceutical companies has been a driving factor for outsourcing. Development performance improvement also acted as a driver fro outsourcing growth. These have brought along the concern of ethics and morale principles as safety profiles of the drugs are under question. Queries in clinical trial cover varied aspects, most importantly safety of humans involved (Saad et al. 2017). The extent of benefits and risks related to a drug often is uncertain, and need clarifications before further processes. A literature review on these two areas was fruitful as much information was gathered from it.

References

Califf, R.M. and Sugarman, J., 2015. Exploring the ethical and regulatory issues in pragmatic clinical trials. Clinical Trials, 12(5), pp.436-441.

Flick, U., 2015. Introducing research methodology: A beginner’s guide to doing a research project. Sage.

Friedman, L.M., Furberg, C., DeMets, D.L., Reboussin, D. and Granger, C.B., 2015. Fundamentals of clinical trials. Springer-Verlag.

Happo, S.M., Halkoaho, A., Lehto, S.M. and Keränen, T., 2017. The effect of study type on research ethics committees’ queries in medical studies. Research Ethics, 13(3-4), pp.115-127.

Homedes, N. and Ugalde, A., 2016. Health and ethical consequences of outsourcing pivotal clinical trials to Latin America: A cross-sectional, descriptive study. PloS one, 11(6), p.e0157756.

Panneerselvam, R., 2014. Research methodology. PHI Learning Pvt. Ltd..

Rosenberger, W.F. and Lachin, J.M., 2015. Randomization in clinical trials: theory and practice. John Wiley & Sons.

Saad, E.D., Paoletti, X., Burzykowski, T. and Buyse, M., 2017. Precision medicine needs randomized clinical trials. Nature Reviews Clinical Oncology, 14(5), p.317.