Cell Preclinical Trials

The concept of stem cell discovery from animal preclinical trials to human subjects comes in handy in making new developments in the health sector. However, such trials should follow several steps as per the FDA guidelines that work to ensure that such tests do not pose unprecedented side effect to human beings. The FDA offers guidelines on how to undergo the entire process towards ensuring the process is transparent in all dimensions of practice and the event, ensure confidence to practitioners and the general public. The stipulated guidelines provide a level playing ground for all stakeholders and ensure the research follows a framework that sets standards for the industry.

Steps in the preclinical trials

The initial test should be carried on healthy volunteers towards establishing any side effects that may be associated with the stem cell discovery. The ideal number of the trial subjects should range between 20 to 80 people. The first step is essential in ensuring the safety of such tests on humans and avoid risking the entire process by exposing the trials to a large number of people. The second stage works to test the effectiveness of the stem cell discovery. Therefore, it aims at obtaining preliminary data on whether the procedure works for people who may suffer from the condition under investigation. In a controlled setting, the stem-cell discovery would be exposed to a group against another that does not receive the same and compare the results. The phase seeks to establish short-term side effects. This stage would engage a higher number of people to a range of 300. The FDA and the sponsoring body come together to discuss the results of phase 2 and come up with an agreement on how large-scale trials should be carried out. The next stage would only come to play if stage 2 was successful in establishing the effectiveness of the stem cell discovery. The people exposed to the test is around 3000, and this only comes to play after FDA has given the go-ahead to market the procedure (U.S Food & Drug Administration, 2018). The stage would be facilitative in gaining more insights on the safety and efficacy of the procedure.

The last step involves the presentation of all animal and human data that came forth owing to the stem cell discovery for analysis by FDA. Information on how the procedure behaves on the human body and the procedure is also captured. The FDA exposes the entire process to review to determine whether to give it a clean bill of rights. The FDA will carry out its review for at least three months towards ascertaining the credibility of the whole process.

Ethical considerations

The practicing body should ensure confidentiality of all people exposed to the trials to avoid unwanted publicity that may result to harassments.  There should be well-placed security measures to protect all the gadgets and files bearing personal information of the participants in the study. Computers should have password and entry to the room should only be restricted to card-key holders or any other similar system that would guarantee to record of each entry. Double encryption of all files bearing information for participants should come to play and should be in possession of high ranking official who is not part and parcel of the research. Further, people who have access to personal information identifies must be subjected to checks, interviews, and training (Lo & Parham, 2012). The volunteers to the stem cell discovery should not be coerced to participate in the study through payments or others, but rather they should be informed of the benefits and risks involved in the entire process for them to decide whether to participate or not.

There should be adequate safeguards that guarantee how the participants in the research will be exposed to serious side effects that are life-threatening. The approach would come in handy to ensure the researchers do not take advantage of the volunteers by exposing them to clinical trials that would leave them with life-threatening conditions. Therefore, this ethical requirement calls for the need to carry out an analysis of pharmacological analysis in humans before administering the clinical trials on humans. The participants should be informed of any imminent and unique risks associated with stem-cell-based clinical trials such as the possibility of a tumor, immunological reactions or any other negative health effects (Nelson, 2013). Any pre-clinical tests on children should be done with the consent of their parents or guardian, and in any case, the trials should only be restricted to low risk and direct benefit to the child. However, children should never be subjected to clinical trials not unless where it is deemed necessary to answer crucial questions that touch on health and welfare of children.

Involving the community

The main objective of the stem-cell discovery is to offer solutions to existing human health problems. Therefore, it is imperative for the researchers to engage the community every step of the way. The approach is vital in the sense that, it would defeat sense for the researchers to complete their research only to have their final results rejected by the same community they were targeting. The researcher should recognize communities are stakeholders in the entire process and as such, the success of their final product depends on their response based on opinions and attitudes they hold on the same.

There are different approaches through which the community should stay informed of the clinical results. For instance, the families of the volunteers in the research should be informed of the results of the clinical trials on their loved ones. Such briefings should contain the true picture of research findings. The volunteers should not be kept in the dark either and as such, they should stay fully aware of the research progress and the findings of the same. All community practitioners such as nurses, social workers, physicians, respiratory therapist just to name but a few and who participate in the trials should stay informed of the clinical trials. People who serve as implementors of the clinical trials such as principal investigators and co-investigators should not be kept in the dark. Informaticians and biostatisticians who design clinical trials should stay on the know. It is imperative to engage people from different races and ethnicities to ensure the research is relevant to their needs. In any case, there should be press briefings and communication through other channels of communication to ensure the general public is aware of the progress of the entire process until full completion is attained (Westfall, et al., 2012). The approach ensures the large community owns the project from the start to the endpoint. Therefore, the public would even feel motivated to participate in the trials without fear.

References

Lo, B., & Parham, L. (2012). Ethical Issues in Stem Cell Research. Endocrine Society, 30(3), 204-213. doi:10.1210/er.2008-0031

Nelson, R. (2013). Overview of FDA Perspective on the Ethics of Stem Cell Therapy. Retrieved from U.S Food and Drug Administration: https://www.fda.gov/downloads/ScienceResearch/SpecialTopics/PediatricTherapeuticsResearch/UCM346996.pdf

U.S Food & Drug Administration. (2018). The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective. Retrieved from https://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143534.htm

Westfall, J., Fagnan, L., Handley, M., Salsberg, J., McGinnis, p., Zittleman, L., & Macaulay, A. (2012). Practice-based Research is Community Engagement. Retrieved from https://iims.uthscsa.edu/sites/iims/files/Westfall_PBR_is_CBPR.PDF