Clinical Trials is a specialized area of study that faces an ever-changing environment. The shifts in this field are happening constantly and rapidly. The changes are taking place not only within the variables being observed but also on external factors such as legal and regulatory landscapes, new findings and discoveries, technological and methodological advancements, and so on.
To keep up with these barriers, Clinical Research and its researchers must be equipped with adequate skills and knowledge in Pharma to ensure the success of the study. In addition to that, the efficiency of the study not only affects the Clinical operation team, but also influences the participants of the clinical trial. According to the research paper, “Keys To Success in Clinical Trials” (Butryn et. al, 2016), the higher the efficiency of a Clinical Research becomes, the more advantages are realized for both the participants and the persons conducting the study.
Making The Commitment
Conducting a Clinical Trial is already a long commitment in itself. The Clinical operation team, including from the investigate site the PI or Principal Investigator, the Study Coordinator (SC) or Study Nurse (SN)). From the Pharma/Biotech or Clinical Research organization (CRO) we have roles such as the Project Manager, CRAs or Clinical Research Associates, and other personnel’s involved in the study must invest not only time but also skills, knowledge, effort, and expertise to ensure the success of the study at hand. Everyone must work together in order to achieve the goal of the Clinical project. So, being prepared for this kind of responsibility is also one of the major considerations before joining a Clinical Trial.
Time, Personnel, and Oversight
Clinical Research takes a long time to take place from conceptualizing a Research Topic, finding the right participants and staff for the study, to experimentation and extrapolation of data, being a part of it is a really long commitment. Most of the people working in a Clinical Trials also have other jobs and external duties aside from the study so carefully planning of staffing and schedule must also be one of the utmost considerations before starting a research.
There is some available support for a Clinical Trial when it comes to manpower. The Clinical Research team might want to consider partnering with site management organizations or clinical trial management organizations. These groups can assume some of the labor in the study and can lessen the burden of the researchers.
Principal Investigator (PI): Qualifications and Responsibilities
Without data, there is no new knowledge generated (Toten, Simon, Jalili & Sawe, 2020). Since Clinical Research requires data and experimentation to answer clinical questions and concerns, new knowledge is beiBased on the paper “Investigator Responsibilities in Clinical Research”, published in The Ochsner Journal, investigators are responsible for 2 things: producing high-quality, significant, scientific research and maintaining public trust (Feehan & Garcia-Diaz, 2020). It can be inferred that a Principal Investigator plays big roles when it comes to conducting Clinical Research. A PI is not only responsible for overseeing the technical side of the study but also is in charge of communication internally and externally.
CRFQualifications
Case Report Forms, or CRF, is a specialized document in Clinical Research to collect and study data. It can
As the famous line goes, “with great power comes great responsibility”, a Principal Investigator, having a tantamount of duties on his or her shoulder, should also bear key credentials, skills, and qualifications in order to facilitate and manage the Clinical Trial effectively and efficiently.
In a document published by the FDA entitled “IRB Responsibilities in Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether and IND/IDE is Needed (2013)”, the IRB or Institutional Review Boards need information about the qualifications of an investigator to completely satisfy the need of the role in terms of conducting and supervision the a Clinical Trial. In addition to that, the IRB also assesses the PI’s training and experience for the proposed Clinical Research if the study has higher risks, vulnerable subjects, or unconventional technology.
Based on a paper published by UNT Health Science Center in 2014 entitled, “Principal Investigators and Co-Investigators: Eligibility, Roles, and Responsibilities”, individuals who are eligible to be a PI should be at least graduate students, visiting professors, visitors in a Postdoctoral position, professors, or anyone not in a permanent employee status.
Based on both of the aforementioned published papers, it can be inferred that the qualifications of a PI may vary from one institution to another. However, the candidates are still subject for review from the IRBs.
Responsibilities
According to one of the published FDA documents, “Guidance for Industry, Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects (2009),” the investigator is responsible for the following:
- Ensuring that a Clinical Trial being conducted is in accordance to the signed statement for Clinical Trials of Drugs, Biological Products, or agreement for the Clinical Research of Medical Devices, the investigational plan, and other applicable regulations
- Protections of the rights, safety, and welfare of the participants within the study.
- Control of drugs, biological products, and devices that will be utilized during the trial.
The aforementioned document released by the FDA also explains that the reason such guidelines were published is to help PIs and Investigators meet the necessary duties while upholding the humanity of the participants and ensuring the quality of data from Clinical Trials. The FDA also said in the document above that publishing these guidelines were not to impose legal responsibilities. The Institution or any organization making the Clinical Trials should only view that as recommendations.
Recruitment and Retention
According to the paper published by Katz, Dufficy, and John in 2011 called “Keys to Success with Clinical Trials”, A fostering and welcoming environment is essential for retention. This is undeniably true not only in Clinical Studies, but also in every group that an individual participates in. But to be specific, patients stay if they realize that they are significant to Clinical Research and not just “breathing numbers.”
WeRecruitment Methods
It is imperative to maintain trust among the physician, study coordinator, and the patient to a successful Clinical Trial recruitment. To make this possible, an open communication must always be active between the PI and referring doctors.
Aside from doing personal endorsements, conventional methods of recruitment such as mailings, lecture and discussion groups, and even radio advertisements are being done to gather more participants in a Clinical Study.
Reasons for Retention
There are a lot of factors that a patient would continue or stay happily in a Clinical Research. Aside from making them feel important by making them more involved and feel significant by constant communication, patients or participants also enjoy privileges and honorariums as tokens of appreciation. Allowances for transportation, food, and other miscellaneous expenses are some examples of honorariums that an institution can give back to the participants in exchange of their time and will to take part in the Clinical Research.
Conclusion
In conducting a Clinical Trial, a lot of investment is needed in terms of financial, expertise, effort, and time. There are a lot of considerations to be made in order to keep the project going. But with all of the barriers affecting the process of Clinical Studies, and the problems that may arise during the actual course of research, proper preparation would enable the team to be equipped with the necessary tools to ensure the success of the trial
References:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3061013/
https://www.ijam-web.org/article.asp?issn=2455-5568;year=2016;volume=2;issue=2;spage=203;epage=216;aulast=Butryn
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7122254/
https://www.fda.gov/files/about%20fda/published/IRB-Responsibilities-for-Reviewing-the-Qualifications-of-Investigators--Adequacy-of-Research-Sites--and-the-Determination-of-Whether-an-IND-IDE-is-Needed-%28Printer-Friendly%29.pdf https://www.fda.gov/media/77765/download
