It is all about helping patients

ClinicalResearch.com is a website that aims to increase clinical research awareness, understanding, and participation. You can use the website to express an interest in becoming a clinical trial investigator (coming soon). You can also learn more about the clinical drug development process and what patients may experience while taking part in a clinical trial in The Patient Journey. In addition, you can register to receive updates on conditions of interest to you, including notifications when new clinical trials start recruiting patients.

Clinical trial investigators are usually physicians in active practice. They are responsible for the day-to-day management of clinical trials at the site level. Their main responsibilities are ensuring patient safety during the trial and safeguarding patients’ rights, making sure that trial activities and procedures are done in accordance with the protocol. Clinical trial investigators are also responsible for maintaining the quality of data collected during the trial.

By conducting clinical trials, physicians can be at the cutting edge of research in their medical field. This may add prestige to their medical practice and respect within the professional community. Being a clinical trial investigator also helps you to connect patients to clinical trials that are right for them.

IQVIA is committed to delivering excellency in clinical trials and adhering to the highest standards of scientific research. With over 30 years of experience in running and optimizing clinical trials, IQVIA has the people, processes, and technology to streamline the investigator experience – from communication to training to workflow for the entire course of a trial.

If you are interested in becoming a clinical trial investigator, you can start by registering in our database (coming soon). Our staff will assess the information provided and contact you when a future clinical trial matches your interest.

Each potential participant in a clinical trial is helped to make an informed decision about their participation, and informed consent is at the heart of this process. The overall purpose of the informed consent process is to offer potential participants detailed information about the trial aim, the tested intervention, potential benefits and risks, specific procedures, and participants’ rights and responsibilities.

Once the potential participant decides to join a trial, they must sign the Informed Consent Form (ICF). Participants have the right to withdraw from the trial at any time without any explanation and without jeopardizing their standard of medical care.

The institutional review board (IRB)/ethics committee (EC) is a local administrative body that safeguards the rights and safety of participants involved in a clinical trial. It reviews trial documentation (e.g. the Clinical Trial Protocol, Participant Information Sheet, and Informed Consent Form) and provides an opinion on the proposed research. The outcome of the review may vary, and the trial can be approved, approved with comments, or rejected.

The IRB/EC members have various backgrounds (e.g. physicians, nurses, statisticians, and community representatives). It operates in accordance with national and/or local regulations and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice guidelines.

The IRB/EC is also entitled to perform periodic checks throughout the trial duration.

The time commitment for participants in a clinical trial varies according to the trial phase and protocol. Usually, trial participants are invited to come to the trial site for a screening visit, followed by several evaluation visits. Other activities may include filling out questionnaires, keeping a research diary, and attending additional visits due to any experienced side effects.

Once the testing of the intervention reaches its end, a follow-up visit or visits may be required. Some clinical trials require just a single follow-up visit or call, while others have longer follow-up periods with several visits at certain intervals. Details like the number of visits, their duration, and their purpose are explained to participants prior to obtaining their consent.

Participation in clinical trials does not normally involve extensive traveling. If it does, trial-related travel costs for participants and caregivers may be covered by the Sponsor. Supporting documents such as receipts and tickets may be required for payment. Details and conditions for the reimbursement are typically explained in the trial's "Participant Information Sheet."

In most clinical trials, participants do not have to pay for any therapy tested or any procedure involved. Throughout a trial, necessary assessments are provided at no cost.

Usually, a participant leaves a trial once participation has ended. The trial itself may continue for longer. Participants typically return to the care of their regular doctor and continue to receive the standard medical care for their condition.

At the end of a trial, the data collected throughout is collated and analyzed. The analysis aims to answer key questions related to the scope of the trial. The main findings may discuss drug safety, side effects, and efficacy of the tested drug, device, or procedure in comparison with the current treatment or placebo. Final results are made available to those who took part in the trial in a lay-language summary. The results also may be published in medical journals, presented at conferences, and/or issued as a press release by the Sponsor.

If a clinical trial phase has a positive outcome, the Sponsor may recommend progressing to the next phase following consultation with regulatory bodies. When the results of several trials suggest that a potential new drug, device, or procedure works and has an acceptable safety profile, the Sponsor usually applies for marketing authorization (product license) to the appropriate regulatory agency (such as the FDA in the United States, EMA in Europe). Cost-effectiveness is considered when deciding whether to grant marketing authorization. Additional cost-effectiveness analysis' are undertaken to compare the new drug, device, or procedure with the current standard of care in terms of cost and benefit. These also consider physician and patient preferences.