Insights into clinical trials

By Francesca Welham

Year 5, Medicine. University of Cardiff

 

Why do patients participate in clinical trials? To answer this question, this project involved reading some of the documentation behind a clinical trial, observing the screening visits and speaking to patients about their experience. The clinical trial was an observational study to compare cells from the inguinal lymph nodes in healthy volunteers with those in individuals with new-onset type 1 diabetes (NOT1D). To find out more about this trial, please visit Type 1 Diabetes UK Immunotherapy Consortium’s website (www.type1diabetesresearch.org.uk), which outlines current research in the field.

What motivated the patients to participate in the clinical trial?

The primary motivation for taking part in the study was that the patients wanted to help develop research in type 1 diabetes and, hopefully, eventually find a way of preventing it. One patient mentioned that they would like to find an answer as to why they had been diagnosed with type 1 diabetes despite there being no family history. Another patient with a medical background wanted to be involved in the study as there was not much research in their field and they had always wanted to be involved in research in some way. They also appreciated how much hard work goes into getting to this stage in a clinical trial. As this was an observational study, there would be little benefit to the health of the patient, however, one patient mentioned that they were planning to take part in a drug trial and hoped that this could possibly treat their diabetes.

How did the patients get involved in the clinical trial?

One patient became involved in the trial via their diabetic specialist and had also signed up to another clinical trial. Another patient became involved after receiving an information pack in hospital and signing up to Address-2, a type 1 diabetes research project that also puts patients in touch with other research projects.1

What did the patients think about the patient information sheets?

The patient information sheet is an essential document that explains, in simple, clear language, the purpose of the study, the risks, the criteria for participation and the study process. It then goes into further detail about some questions the participants may have. With regard to the information sheets, the patients felt happy with the amount of information provided (despite it being long) and they found it easy to understand. One patient said they thought it would be beneficial to also have a video with a friendly face explaining the trial and the procedure (possibly with clips of the rooms and procedure).

How did the patients find the screening visit?

The screening visit involved a dialogue with the doctor about the study and the patient’s medical history, ensuring that all the criteria for the study had been met. This visit had met the expectations of some individuals, although one patient had expected to have the biopsy on the day and thought it would involve surgery. Maybe this reflects a lack of clarity in the information sheet, which could be addressed with some photos or a more in-depth description of the procedure. All patients also expressed that they had no concerns and felt their questions had been answered in the screening visit.

Finally, the patients felt that being involved was not an inconvenience, particularly as they appreciated being compensated for their time, travel and accommodation. The suggestions for improvements included:

  • Having satellite clinical research units in hospitals nearer to patients for screening visits
  • Having someone available for patients who are worried about their new diagnosis to talk to

What can be learnt from this project?

This project gives an insight into what motivates patients to become involved in clinical trials. It is equally important to consider the ethical issues regarding patient participation in clinical trials in order to avoid the exploitation of a vulnerable group. To ensure ethical compliance, a clinical trial must be used to successfully answer a question that has both social and clinical value.2 In addition, only patients who meet the criteria for a clinical trial should be recruited, and the fundamental process of informed consent must be carried out.2 The key aspects of this are to inform the patient of what will be involved in the study and the risks and benefits of participation in order to enable the patient to understand this information and reach a decision voluntarily.2 There is still controversy around the issue of payment in clinical trials as, although this is often provided as compensation for time and travel, this should not become a source of coercion.3 Once a patient is participating in a clinical trial, it is important that they are respected with regards to their privacy, wishes to withdraw, monitoring and being informed of developments in the field and results of the current clinical trial.2

 

Acknowledgements I would like to thank Professor Dayan and Doctor Ali for enabling me to have the opportunity to conduct this research.

Copyright This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. To view a copy of the license, visit https://creativecommons.org/licenses/by-nc-nd/4.0/legalcode. The copyright of all articles belongs to the author(s), and a citation should be made when any article is quoted, used or referred to in another work. All articles included in the INSPIRE Student Health Sciences Research Journal are written and reviewed by students, and the Editorial Board is composed of students. Thus, this journal has been created for educational purposes and all content is available for reuse by the authors in other formats, including peer-reviewed journals.

References

  1. Address-2 (2017)Welcome to ADDRESS-2. Available from: www.address2.org/.
  2. NIH Clinical Center (2019) Patient recruitment: ethics in clinical research: ethical guidelines Available from: https://clinicalcenter.nih.gov/recruit/ethics.html.
  3. Ahmad W, Al-Sayed M. Human subjects in clinical trials: ethical considerations and concerns. Journal of Translational Science, 2018. doi: 10.15761/JTS.1000239

 

 

 

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