Everything You Need to Know About Clinical Research Studies
Clinical research studies are the cornerstone of medical progress. But what exactly are they, and how can you be involved? This blog unveils the fascinating world of clinical trials, exploring how they lead to new medications, preventative measures, and improved treatments for a healthier future.
Clinical Research Studies
In the ever-evolving landscape of medicine, clinical research studies act as the engine driving progress. These meticulous investigations pave the way for the medications we rely on, the treatments that improve lives, and the preventative measures that keep us healthy. But what exactly are clinical research studies, and how can you get involved? This comprehensive guide will equip you with all the essential knowledge.
What are Clinical Research Studies?
Clinical research studies are scientific investigations that meticulously explore the effects of new medical interventions on human participants. These interventions encompass a diverse range, including:
Medications: Think of the medications you take daily. Before reaching pharmacies, new drugs undergo rigorous testing in clinical trials to assess their safety and efficacy.
Surgical procedures: Novel surgical techniques are evaluated for effectiveness, safety, and potential complications through clinical research studies.
Medical devices: From pacemakers to artificial joints, the safety and intended benefits of medical devices are demonstrably proven through clinical trials.
Behavioral therapies: Clinical research studies assess the effectiveness of new approaches to managing chronic conditions or mental health concerns compared to traditional methods.
Preventative measures: These studies evaluate the efficacy of new strategies for preventing diseases and promoting overall health.
1. Clinical Research Coordinator Certification: career opportunities in clinical research.
If you're interested in overseeing clinical trials and managing their daily operations, consider becoming a certified Clinical Research Coordinator ( https://app.ccrps.org/courses/Clinical-Research-Coordinator ).
2. Pharmacovigilance Certification : Suitable for the section discussing the importance of monitoring drug safety in clinical trials.
Enhance your expertise in monitoring the safety of pharmaceuticals and medical devices by pursuing a Pharmacovigilance Certification( https://app.ccrps.org/courses/pharmacovigilance-certification ).
3. CRA (Clinical Research Associate) Certification: This link can be included in parts talking about roles involving the monitoring and operational management of clinical trials.
Learn to plan and oversee clinical trials to ensure adherence to regulatory standards with a CRA Certification( https://app.ccrps.org/courses/cra ).
4. ICH-GCP (Good Clinical Practice) Training: Place this link in sections discussing the ethical and regulatory standards guiding clinical research.
Gain a thorough understanding of the international ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve human subjects with ICH-GCP Training( https://app.ccrps.org/courses/ich-gcp ).
5.Clinical Trials Assistant Training: This link fits well in sections discussing entry-level positions in clinical research.
Start your career in clinical research by getting trained as a Clinical Trials Assistant( https://app.ccrps.org/courses/Clinical-Trials-Assistant-Training ), which will provide you with the necessary foundation to support clinical studies.
6. *Advanced Clinical Research Project Manager Certification*: Ideal for discussing advanced career paths in managing extensive clinical research projects.
For those aiming to lead complex clinical trials, consider the [Advanced Clinical Research Project Manager Certification( https://app.ccrps.org/courses/Advanced-Clinical-Research-Project-Manager-Certification ) to enhance your project management skills.
7. Advanced Principal Investigator Physician Certification: Place this link where leadership roles in clinical trials are mentioned.
If you aspire to lead clinical trials and make impactful decisions, the [Advanced Principal Investigator Physician Certification( https://app.ccrps.org/courses/Advanced-Principal-Investigator-Physician-Certification ) is an excellent pathway.
8. Medical Monitor Certification*: Include this link in parts discussing the roles focused on overseeing the medical aspects of clinical trials.
Specialize in monitoring the medical aspects of clinical trials with [Medical Monitor Certification]( https://app.ccrps.org/courses/medial-monitor-certification ), ensuring the highest standards of participant safety and study integrity.
Clinical research studies can answer specific questions about:
New drugs, products, and therapies
Treatments for existing conditions
New ways of using known treatments
The Impact of Clinical Research Studies
Through clinical research studies, clinical research investigators are constantly pushing boundaries and finding new and better ways to:
Prevent illnesses and conditions: These studies pave the way for preventative measures like vaccines and lifestyle modifications.
Diagnose and detect diseases: New diagnostic tools and techniques are often developed through clinical research.
Control and treat illnesses: Clinical trials play a vital role in identifying effective treatments for various conditions.
Improve the quality of life: The discoveries made through clinical research studies have significantly improved the quality of life for those with chronic illnesses or life-threatening diseases.
Finding Clinical Research Studies: Your Gateway to Participation
Thinking about participating in a clinical research study? There are resources available to help you find the right opportunity:
ClinicalTrials.gov : This U.S. database, sponsored by the federal government and private organizations, lists a vast number of clinical research studies. You can search for trials by location, condition, and other criteria to find studies that align with your interests.
Developed by the National Library of Medicine (NLM) in collaboration with the National Institutes of Health (NIH) institutes and the Food and Drug Administration (FDA), ClinicalTrials.gov provides easy access to information on clinical trials for various diseases and conditions.
What is Tested in Clinical Research Studies?
Clinical research studies encompass a broad spectrum of medical interventions:
Behavioral, counseling, or psychological treatments: These are often assessed through questionnaires designed to understand patient needs and the effectiveness of the intervention.
Drugs, medical devices, or biologics: New drugs, medical devices, and biologics like blood products, gene therapy, or vaccines undergo rigorous testing in clinical trials before becoming available to the public.
The Phases of Clinical Research Studies:
Clinical research studies are conducted in four distinct phases:
Phase 1: This initial phase involves testing the new drug or treatment in a small group of people, typically 20 to 100 participants. The primary focus is on safety and determining the appropriate dosage.
Phase 2: The study expands in Phase 2, with the new drug or treatment being tested on a larger group of people, usually ranging from 100 to 300 participants. Here, researchers assess the effectiveness of the intervention for the intended condition.
Phase 3: Phase 3 trials involve an even larger group of participants, typically numbering in the hundreds or even thousands. This phase aims to confirm the effectiveness of the intervention compared to existing treatments or a placebo and gather further data on safety and side effects.
Phase 4: After a new drug or treatment receives approval and becomes commercially available, Phase 4 studies monitor its long-term effects and safety in the general population.
Join the Movement: A Career in Clinical Research
The clinical research world is a dynamic field constantly seeking qualified professionals. If you're passionate about making a positive impact on healthcare, consider a career in clinical research. There are numerous opportunities for certified, competent, and responsible individuals to contribute to a greater and better clinical research world.
By incorporating this additional information, the blog offers a more comprehensive understanding of clinical research studies, their impact, and the various ways people can get involved.
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course
Clinical Research Project Manager
Clinical Research Project Manager - A Full Guide To Becoming a Clinical Trial Project Manager
As of mid-April 2022, top recruitment platform ‘indeed.com’ lists 6,026 openings for Clinical Research Project Managers across the United States[1]. According to ‘payscale.com’, remuneration for this profile ranges from $84,168 for early-career to $120,501 for experienced Clinical Research Project Managers, with a mid-career median of $107,649[2].
A Clinical Research Project Manager (henceforth CRPM) is also known as a Clinical Research Manager or a Clinical Trial Manager. The role of a CRPM is to provide leadership during the clinical trial of new drugs, with the overarching goal of ensuring that the clinical trials process is completed within the stipulated time-frame and allocated budget, while maintaining the highest standards of research quality and scientific integrity.
An overview of the CRPM profile
A Clinical Research Project Manager is the liaison between the study sponsor and the clinical research team. Thus, the CRPM must balance the expectations of the funding organization in a clinical research study (pharmaceutical company, governmental agency, university research division or other entity) with the needs of the team, including Principal Investigators (PIs) and co-PIs, Clinical Research Coordinators (CRCs), Clinical Research Associates (CRAs), and Clinical Trial Assistants (CTAs) and other site staff.
The CRPM plays a leading role in planning, implementation and ongoing monitoring of live clinical trials. In the process, a CRPM also mentors junior team members, including CRAs and CTAs.
Evidently, a career as a CRPM is rewarding, but also demanding. So, what does it take to qualify and be recruited as a Clinical Research Project Manager?
The road-map to becoming a CRPM
Even if you’re new to the field of clinical research, you’ve probably guessed by now that becoming a Clinical Research Project Manager takes both qualifications and experience. A typical CRPM has a bachelor’s (or master’s) degree in life science, combined with four to five years’ experience in one or more clinical research roles such as CRC, senior CRA or QPPV (Qualified Professional in Pharmacovigilance).
Irrespective of where you are along this path, the remainder of this article charts a clinical research professional’s journey of growth in developing into a competent CRPM. For conceptual convenience, the process is discussed in two parts – Part 1 centers on the research and administrative skills needed for a CRPM, while Part 2 revolves around expertise in project management. The final sections address how the Advanced Clinical Research Project Manager Certification or ACRPMC facilitates the transition to a CRPM role.
The CRPM journey, Part 1: Research and administrative skills
By the time a clinical research professional is eligible to apply for a CRPM position, s/he has typically developed a range of competencies in the day-to-day running of clinical trials. In addition, a professional at this stage has usually acquired a good working knowledge of the planning and oversight required for a clinical research study.
In broad strokes, a CRPM candidate likely already has a knowledge base and skill sets in the following areas:
1. ICH-GCP guidelines, Title 21 of FDA CFR and IRB compliance
One of the first things every clinical research professional learns is the importance of adhering to the principles and policies of good clinical practice, as outlined in the ICH-GCP[3]—these guidelines set the framework for carrying out research in a manner that prioritizes the safety and welfare of human subjects and the quality and integrity of clinical data.
The ICH-GCP principles are mirrored by Title 21 within the US FDA’s Code of Federal Regulations (CFR)[4]. Clinical research across the US must conform to the requirements of Title 21. Part of Title 21 regulatory compliance requires nearly all clinical research studies to first be approved by an Institutional Review Board or IRB (also called an Ethics Committee). As clinical trials progress, any changes to the study trial protocol, consent procedures or data management system must likewise first be reviewed and approved by the IRB.
The CRPM has final responsibility for ensuring that all documentation necessary for clinical research regulatory compliance is maintained and updated as needed.
2. Clinical trial design concepts and parameters
A sound grasp of the clinical trials process is similarly a must for senior professionals in the team. Candidates for CRPM positions are thus expected to have a thorough understanding of key concepts and procedures relating to clinical research, including:
Phases 1 to 4 of clinical trials[5]
Investigational products (IPs) including INDs and IDEs
Design concepts in clinical trials - control, randomization and blinding
Subject screening and selection, retention and study compliance
Trial data input, quality assurance, analyses and reporting
Adverse Event (AE) documentation and reporting
3. Pre-trial preparation
In some ways, the most crucial phase of a clinical trial is the preliminary or preparatory phase, during which all groundwork must be laid for the smooth and efficient conduct of the actual study. This phase must typically achieve the following objectives:
Complete documentation for initiating clinical trials[6] – An IRB-approved clinical trial must have in place a host of documents covering important aspects of the study, including the investigator brochure (IB), trial master file (TMF), informed consent form, case report form (CRF), subject recruitment notice, laboratory protocol, study financial projections and so on.
Identification and preparation of study site(s) – Most clinical research studies are run across multiple sites, which may be hospitals, clinics or other health-care facilities. Identifying suitable sites, establishing collaborative agreements with site administrators, as well as setting up the required infrastructure to carry out trials at each site is crucial in preparing for a clinical research study.
Pre-trial publicity – The success of clinical trials depends on gathering large amounts of data from human subjects. Therefore, creating public awareness and interest right from the outset is critical to running clinical research studies effectively.
When setting up a study, the CRPM plays a central role in initiating and fulfilling each of the goals outlined above. Under the CRPM’s guidance, clinical research administrative staff including CRCs and CRAs work to put relevant documentation in place, prepare study sites and create public awareness about the study.
4. Active trial administration
The day-to-day running of an active clinical trial involves numerous administrative components, including:
hiring and training staff at clinical sites
tracking subject recruitment and retention
regulatory compliance in trial protocol, subject safety and data quality
Adverse Event (AE) documentation and reporting
oversight of trial drug storage and use
coordination among research teams across sites
tracking study finances
communication between study sponsors and clinical staff
electronic data capture (EDC) and management
timely renewal of necessary financial and regulatory approvals
These tasks are distributed among members of the investigative teams (PIs, co-PIs and other medical personnel) as well as administrative teams (CRAs, CRCs, QPPVs and other site staff). However, the CRPM is ultimately responsible for ensuring efficient administration that keeps the clinical trial on track.
5. Study termination procedures
Winding up a clinical trial similarly entails a number of administrative exercises. Here again, the CRPM must oversee execution, guiding team members in completing tasks on schedule and to the required standard:
site close-out (relieving staff, subject debriefing, equipment surrender)
final data consolidation and scrutiny
study completion documents for regulatory compliance
compilation of briefs and reports for regulatory authorities, study sponsors
The CRPM journey, Part 2: Expertise in project management[7]
Most aspirants to CRPM positions have usually been engaged in the clinical research process for at least a few years. Many have played administrative roles, working as CRCs, senior CRAs, QPPVs or site managers. In some cases, CRPM aspirants have clinical backgrounds, with expertise in drug research or medical monitoring.
Despite their hands-on experience with the clinical trials process, professionals wishing to transition to CRPM roles usually have limited exposure to the higher-level project management knowhow that is essential for an effective CRPM. This section provides a brief overview of the major project management domains relevant to clinical trial management:
1. Project and operations planning
A clinical trial is a major operation, involving a range of geographical and health-care settings, multi-disciplinary teams, as well as a complex array of regulatory and logistical requirements. Planning the stages, milestones and operations of a clinical trial is integral to assuring its success. Therefore, project and operations planning are the top priorities of a CRPM.
Some of the key elements involved in planning a clinical trial include:
Compiling a comprehensive study protocol describing the rationale, aims, design and methodology, data analysis plans, and trial procedure (/protocol)
Setting project goals, deliverables and milestones
Outlining a project personnel schematic that delineates team and sub-team structure and defines individual team member roles
Generating a responsibility blueprint with a clear break-up of tasks, targets and time-lines for each project goal and each team member
Creating a communication plan that outlines the method and schedule for relaying information, updates and requests between and within teams
2. Financial forecasting and tracking
One of the biggest challenges confronting a CRPM is keeping the trial within budget, while making sure that resources are optimally allocated to cover all necessary project-related expenses. Clinical trials often suffer from scope creep, that is, the inclusion of additional goals and deliverables to those originally outlined, resulting in the project overshooting budget and time-line.
It is therefore recommended practice for a CRPM to work with study sponsors and senior team members in compiling a budget management plan at the very outset of the project. Such a plan not only specifies financial outlay for each of the goals and deliverables of the clinical trial, it also provides for periodic budget revisions to account for factors such as expanded project scope, rising costs and supply-chain changes.
3. Human resource allocation and oversight
The section on project and operations planning highlighted the importance of creating a personnel schematic as well as a responsibility blueprint at the start of a clinical trial. Through this process, a CRPM is able to clearly define roles for various team members in meeting project goals and milestones, and their contributions to each project deliverable.
However, in order to ensure collaborative effort and a cordial work environment, it is essential for a CRPM to also formulate a transparent hiring policy as well as disciplinary policy. These may be specific to the clinical trial or apply broadly across the CRO, or Clinical (/Contract) Research Organization. Well-documented policies facilitate the CRPM’s role in sourcing and motivating the best-fitted staff to play different roles in the clinical team.
4. Clinical data management and quality control
The data from a clinical trial are often its most valuable project outcome. As such, effectively managing the input, storage, analysis and quality control of study data is one of the foremost responsibilities of a CRPM.
Before beginning the active phase of the clinical trial, a CRPM coordinates with team members to put in place the following aspects of data management:
physical data storage system (files, binders, shelves, cabinets, etc.)
electronic data capture (EDC) and management system
physical and electronic data security systems
data input procedure
data cleaning and quality monitoring procedure
data sharing (import, export, access across clinical sites and teams)
data analysis and visualization procedure
periodic data review and reporting procedure
5. Risk management and mitigation
Owing to the high stakes nature of clinical research, running a clinical research study carries numerous risks. One of the major responsibilities of a CRPM is to develop a risk management plan to identify and circumvent potentially risky situations, and to mitigate consequences to the project in cases where an unforeseen risk impacts the trials process.
Some sources of risk in the management of a clinical trial include:
failure to obtain or document subject informed consent
errors in following trial protocol (timing, dosage, subject screening, etc.)
data security breach leading to compromised subject confidentiality
inadequate insurance coverage for potential adverse events of study
financial constraints arising from changes in study funding
limitations on study scope due to revisions in regulatory policy
Bridging the gap: Using ACRPMC to transition from clinical research professional to project manager
The foregoing section outlined how, despite their strong base in clinical research, CRPM aspirants generally lack the advanced knowhow and managerial skills required for leading a clinical research project. CCRPS’ Advanced Clinical Research Project Management Certification (ACRPMC) provides an excellent tool for bridging this gap and bringing candidates up to speed in all domains of clinical research management.
The table below offers a summary of the focus areas of the ACRPMC, detailing how each contributes to enhancing a candidate’s expertise and eligibility for the role of a Clinical Research Project Manager.
ACRPMC Focus Area |
Contribution to CRPM Candidate Eligibility |
ADVANCED REVIEW - I: Regulatory compliance in clinical research |
i.Fundamentals of subject (/patient) safety, ICH-GCP E6, Sections 2 - 4 |
ii.Regulatory compliance – FDA-CFR Title 21, Forms FDA 1571, 1572, 3454, 3455 |
|
iii.Investigational New Drug (IND) & New Drug Application (NDA), Investigational Device Exemption (IDE) |
|
iv.IRB, Data Safety Monitoring Board (DSMB)[8] |
|
ADVANCED REVIEW - II: Clinical trial concepts |
i.Process & phases of clinical testing (pre-clinical and phases 1 to 4) |
ii.Importance of ‘control’ in testing[9], outcome validity, control methods (randomization, blinding) |
|
iii.Subject (/patient) selection[10]: screening & exemption criteria, selection & retention, study compliance |
|
iv.Clinical trial data management[11]: EDC, Clinical Trial Management Systems (CTMS), Interactive Response Technology (IRT), Randomization & Trial Supply Management (RTSM) |
|
v.Subject safety[12]: Risk assessment & Individual Case Safety Reports (ICSRs), Adverse Events (AEs), Adverse Drug Reactions (ADRs), Important Medical Events (IMEs) |
|
ADVANCED REVIEW - III: Pre-trial preparation |
i.Documentation[13]: Regulatory binder, Investigator Brochure (IB), Trial Master File (TMF), Case Report Form (CRF), Delegation of Authority Log (DOAL), etc. |
ii.Site preparation[14]: Site Selection Visits (SSVs), Site Qualification Visits (SQVs), site management agreements, investigator selection |
|
iii.Pre-trial publicity: Advertisement for subject recruitment & retention |
|
ADVANCED REVIEW - IV: Active trial management & trial termination |
i.Clinical trial protocol compliance, deviations & violations |
i.Clinical site monitoring: subject safety, drug storage & safety, regulatory compliance |
|
ii.Data monitoring: data security & access, Quality Management System (QMS), Quality Control (QC), Key Quality Indicators (KQI) |
|
iii.Team monitoring: communication & collaboration, adherence to trial & safety protocols, research integrity & fraud |
|
iv.Reviews & audits[15]: document & site audits, data audits, financial audits |
|
v.Study termination: site close-out visits, data consolidation, subject debriefing |
|
EXPERTISE BUILDING - I: Clinical project management fundamentals |
i.Project management basics[16]: key concepts, Project Management Body of Knowledge (PMBOK) |
ii.Skills of a project manager: technical, administrative, human resources, public relations |
|
iii.Clinical project stakeholders: sponsors, IRB, investigative & administrative staff, site administrators |
|
EXPERTISE BUILDING - II: Advanced clinical project management |
i.Project planning & tracking, progress evaluation metrics |
ii.Financial management[17]: project budgeting, site budgeting, advertising budget, payment tracking and management |
|
iii.Risk management & problem solving[18]: problem solving managerial skills, identifying risks, avoiding failures, resolution of project problems (protocol deviations, compliance failures, project delays) |
Fast-track to CRPM with the ACRPMC advantage
From the above summary table, it can be seen that the ACRPMC[19] program of CCRPS covers the entire spectrum of competencies required for managerial clinical research professionals. In addition to providing in-depth training in clinical project management concepts, tools and techniques, the program includes a review of foundational as well as advanced knowledge of the clinical trials process.
Aside from its comprehensive curriculum, certification through ACRPMC offers major benefits over conventional clinical research management courses, both online programs as well as those offered by colleges and universities. Some of the outstanding advantages of ACRPMC are:
1. Foundational review plus advanced training
The ACRPMC program stands apart from other online programs in its unique ability to launch as well as advance careers in clinical research. The program is equally effective at helping an aspiring graduate (BA in science or BS degree) to gain a competitive advantage in the clinical research job market, as it is at catapulting a senior clinical researcher into a managerial position.
For CRPM aspirants in particular, the ACRPMC provides an unrivaled opportunity to brush up on the basics, in addition to acquiring valuable knowhow in clinical research project management, before embarking on the applications and interview process.
2. Over 100 training modules (250 hours of coursework)
The course comprises over 100 modules. The advanced review focus areas address all aspects of the clinical research process, including important investigative concepts (trial design, randomization, subject screening, data analysis, etc.) as well as administrative processes (maintenance and updating of regulatory documents, case reports, trial logs, etc.). Additionally, the expertise building focus areas of the ACRPMC cover basic and advanced project management concepts and skills that equip candidates to tackle the challenges of leading a clinical research study.
3. ICH-GCP E6R2 compliant
Designed by experienced Clinical Research Project Managers, the ACRPMC curriculum is fully compliant with the regulatory requirements of the ICH-GCP E6R2. The course coordinators additionally ensure that the content is regularly updated to reflect revisions to policy and new requirements.
4. Immediate enrollment and fast-tracked certification
Unlike college and university courses, trainees can enroll in the ACRPMC with just a few clicks. In addition, the self-paced course design allows students to skim through familiar topics, while giving more time and attention to new material. This is especially advantageous for working professionals and senior clinical research professionals wishing to refresh their knowledge. Trainees able to dedicate several hours per day to the program can complete the ACRPMC in as little as two weeks.
5. Multiple accreditations and industry-wide recognition
For ACRPMC-certified trainees, the solid credentials of the program confer a huge benefit when applying and interviewing for clinical research positions. Like other CCRPS courses, the ACRPMC is also accredited to ACCRE (Accreditation Council For Clinical Research and Education), ACCME (Accreditation Council for Continuing Medical Education) as well as ACPE (Accreditation Council for Pharmacy Education).
6. Clinical research résumé building and interview preparation
The final modules of the ACRPMC help trainees in building their ability and confidence to face interviews for clinical research positions. Trainees completing the comprehensive final examination not only have immediate access to a digital certificate, but are eligible to receive a letter of recommendation (LoR) that can strengthen their clinical research job application.
As the clinical research industry continues to grow at an unprecedented pace, there is rising demand for Clinical Research Project Managers who can blend their skill and experience in clinical research with savvy, expert project management abilities. As a professional clinical researcher, the ACRPMC program offers you an unmatched opportunity to refresh existing knowhow and acquire new competencies, thereby leveraging your rise to the top echelons of management.
If you are a fresh graduate, the ACRPMC represents an unequaled, early-career edge in the clinical research arena. By equipping you with foundational as well as advanced knowledge and skills, ACRPMC certification does not merely improve your chances of securing an attractive clinical research position, it assures the rapid upward growth of your career graph.
Advanced Clinical Research Project Manager Certification (ACRPMC) program advantages.
References
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https://www.payscale.com/research/US/Job=Clinical_Trial_Manager/Salary
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https://app.ccrps.org/courses/Advanced-Clinical-Research-Project-Manager-Certification
