Giving fact-based answers to crucial medical questions is the essence of clinical research. To do this straightforward yet complex objective, the clinical operations department should function in accordance with solid scientific approaches. Producing authentic and well-grounded information is one of the many purposes of clinical trials. The goals of a clinical trial are often shaped in the early stages of the study. In clinical trials, planning is as important as execution.
One of the major problems that a clinical trial manager faces is the cost of running the study. Even though the funds come from the stakeholders and sponsors of clinical projects, budget is always a recurring issue in this field. Not only that, the length of completing a clinical study is lengthy. As highlighted by Dr. Sun, a professor of Pharmaceutical Sciences at the University of Michigan, developing one successful drug can cost around $1 billion . This costly figure is also backed by the study conducted by Wouters, McKee, and Luyten (2020) wherein the medium of expenditures for conducting clinical trials between 2009 to 2018 were calculated . In addition, he points out that, along with the colossal amount of funds that have to be invested into a trial, consistent and extensive long-term efforts should also be provided because a trial could last around 10 to 15 years .
According to an article published by Applied Clinical Trials, the sufficient time that a clinical project should give to the planning of the study is at least six months . Since planning is the fundamental stage of any successful project, clinical operations should lay out and underline all the necessary steps, consequences, solutions, and other relevant scenarios that the study might undergo. To maximize the chances of success and minimize error or casualty, the clinical project management that determines the study’s consideration should always be proactive and not reactive.
Good Clinical Practice
As discussed by Ahmad and Al-Sayed, in the article “Human Subjects in Clinical Trials: Ethical Considerations and Concerns” (2018), the ICH-GCP guidelines state that all clinical operations should be in agreement with ethical standards and clear scientific proof . It also declares that benefits should always outweigh the risks. Alongside these conditions, the ICH-GCP guidelines also tell that the protocols should be well-documented. It also talks about the assurance of confidentiality of patients and the quality of staff based on their training and qualifications.
GCP or Good Clinical Practice is an international direction on implementing a standardized process of clinical project management accurately, efficiently, scientifically, and ethically. Although not an official standard yet, GCP was universally followed as early as 1997. In 2004, GCP has become a legal responsibility for all clinical trials that involve investigational products.
The International Council for Harmonization (formerly known as the International Conference on Harmonization) birth took place in Brussels in the month of April 1990. The aim of this regulatory body is to provide guidelines for the harmonization of clinical trials in terms of safety, quality, and efficacy
Protection of the Participants
As described in the ICH Harmonized Guidelines, General Considerations for Clinical Studies E8-R1 (2021), The Declaration of Helsinki should be strictly monitored at all times in human clinical projects . Furthermore, the investigators and the sponsors have responsibilities for securing the dignity and humanity of participants along with the International Review Board (IRB) or Independent Ethics Committee. The document also gives important highlights to the transparency of clinical operations management in their process. It states that before conducting a study, sufficient information should be readily available to validate that a certain drug or treatment is safe for human consumption and relevant in human studies. Also, data should be reviewed and evaluated by qualified experts to correctly analyze the effects of the study on the participants in order to secure their general welfare. In short, throughout the entire phase of the study, the clinical project shouldn’t be a burden or a threat to participants.
Informed Consent (IC)
Informed Consent is made to enlighten the participants about the inherent risks, benefits, and rights when they wish to join an expert clinical trial. Obtaining an IC is an essential part of the patient recruitment process and a legal requirement before a conducting clinical trial. The Principal Investigator (PI) is responsible for the explanation of the IC. The PI is also in charge of determining if the subject understood the information clearly and has given approval for voluntary participation.
As reported by Ahmad and Al-Sayed (2018), Informed Consent Form (ICF) should clearly declare the clinical project’s objective, duration, procedures, risks, benefits, treatment options, and the confidentiality details pertaining to the subject’s information .
Payment and Reimbursement to Research Subjects
According to the International Ethical Guidelines for Health-related Research Involving Humans, prepared by the Council for International Organizations of Medical Sciences (CIOMS) and the World Health Organization (WHO), a participant in a clinical trial should receive a justifiable amount of compensation from the sponsors for the costs incurred for the duration of the research . The compensation can be monetary or non-monetary such as receiving regular medical attention from the research team and other healthcare professionals, educational materials, and so on. It further states that the compensation should not be so big as not to entice the subjects to go against their will or judgment. However, the reimbursements that would be provided to such participants should always be approved by the local research ethic committees.
Clinical operations management is as overwhelming as it seems. Factoring in the number of considerations that have to be taken into account, a clinical project might be needing help from a third-party provider - and it is just normal in this kind of industry. Clinical operations consulting can provide clinical operations expertise and solutions to ensure the success of the trial from beginning to end. Considering the odds of success, involving many great talents might not be a bad idea in addressing such tantamount considerations in clinical studies.
- Sun D. 90% of drugs fail clinical trials – here’s one way researchers can select better drug candidates. The Conversation [Internet]. 2022 Feb 23 [cited 2022 Sep 23]; Available from: http://theconversation.com/90-of-drugs-fail-clinical-trials-heres-one-way-researchers-can-select-better-drug-candidates-174152
- Wouters OJ, McKee M, Luyten J. Estimated research and development investment needed to bring a new medicine to market, 2009-2018. JAMA [Internet]. 2020 [cited 2022 Sep 23];323(9):844–53. Available from: https://jamanetwork.com/journals/jama/fullarticle/2762311
- A 6-month process for planning multinational clinical trials [Internet]. Applied Clinical Trials Online. 2003 [cited 2022 Sep 23]. Available from: https://www.appliedclinicaltrialsonline.com/view/6-month-process-planning-multinational-clinical-trials
- W A, Al-Sayed M. Human subjects in clinical trials: Ethical considerations and concerns. J Transl Sci [Internet]. 2018 [cited 2022 Sep 23];4(6). Available from: https://www.oatext.com/human-subjects-in-clinical-trials-ethical-considerations-and-concerns.php
- International council for harmonisation of technical requirements for pharmaceuticals for human use [Internet]. Ich.org. 2021 [cited 2022 Sep 23]. Available from: https://database.ich.org/sites/default/files/E8-R1_Guideline_Step4_2021_1006.pdf
- ch. [cited 2022 Sep 23]. Available from: https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf