Innovations in clinical trials are necessity, and it is important to slowly involve them into process of the trial if we want to maintain the quality. The costs of clinical trials are increasing while all patient’s needs are not fulfilled, and so clinical trials are longing for changes.
A theory [or simulation] is something nobody believes, except the person who developed it.
An experiment is something everybody believes, except the person who performed it.Albert Einstein
Patient- centric clinical trials
The rise of patient-centric trials is current trend that will continue to grow and won’t go away. This innovation shows the importance of transparency and engagement of participants in their own healthcare. For example, listening to patients needs while creating informed consent form (ICF) and protocol. It is not uncommon that patients don’t understand these documents, but their opinion should be considered. Informed consent form is first step in every clinical trial and it is very important to make this process interactive. This kind of proactive approach with customized recruitment could result in involving more patients into studies. Customization will have big role in this part of trial, and for that reason site staff needs to be prepared for modifications. To wrap whole process, patients should be encouraged to give their post-trial insights.
Virtual clinical trials
Inevitably, as in other areas in our life, virtual is becoming a thing in clinical trials. Incorporation of digital health technologies leads to easier way for collecting information. For instance, participants can be engaged from their homes and that can eventually result in involving more patients. Virtual trials can reduce visits at the clinical site, accelerate conduction of research, decrease costs and make trials more efficient. Aside many advantages, there are on the other hand disadvantages related to technical issues and operational challenges. Developing structure for this kind of trials has been speeding up with coronavirus disease (COVID-19) pandemic.
Currently, hybrid model, that includes several virtual elements combined with established on-site activities, shows best results and could be easily introduced into process of clinical trials.
Picture 1. Digitally enabled clinical trials and potential benefits (Dockendorf et al, 2021)
Patient-centric trials act synergistically with virtual clinical trials. Participants are more involved and drug development is more dependent on patients than on the provider of study.
It’s good to be aware that the combination of these trends brings new and interactive clinical trial model.
- Sharma N. S. (2015). Patient centric approach for clinical trials: Current trend and new opportunities. Perspectives in clinical research, 6(3), 134–138. https://doi.org/10.4103/2229-3485.159936
- Samei, E., Kinahan, P., Nishikawa, R. M., & Maidment, A. (2020). Virtual Clinical Trials: Why and What (Special Section Guest Editorial). Journal of medical imaging (Bellingham, Wash.), 7(4), 042801. https://doi.org/10.1117/1.JMI.7.4.042801
- Persky S. (2020). A Virtual Home for the Virtual Clinical Trial. J Med Internet Res, 22(1):e15582. https://www.jmir.org/2020/1/e15582 DOI: 10.2196/15582
- National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Forum on Drug Discovery, Development, and Translation. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Shore C, Khandekar E, Alper J, editors. Washington (DC): National Academies Press (US); 2019 Jul 23. PMID: 31334937.
- Dockendorf MF, Hansen BJ, Bateman KP, Moyer M, Shah JK, Shipley LA. Digitally Enabled, Patient-Centric Clinical Trials: Shifting the Drug Development Paradigm. Clin Transl Sci. 2021 Mar;14(2):445-459. doi: 10.1111/cts.12910. Epub 2020 Nov 30. PMID: 33048475; PMCID: PMC7993267.
- Website: https://www.appliedclinicaltrialsonline.com/view/practical-overview-patient-centric-trials