Management Report on Clinical Phase III Cancer Trials Assignment Sample

Management Of A Clinical Trial

Introduction

Clinical research and management system can be regarded as the systematic study that has been used for manufacturing new drugs for generating data to discover as well as verify Pharmacological, Clinical and adverse effects along with the objectives to determine the efficacy and safety of the new drugs. The main focus of Clinical research management deals with the integration of patient care with the end goal of treating patients with new and effective medicines. It has been observed that the core program of clinical research management mainly covers the practise and theory of the statics, research methods, legal and regulatory framework that have been important for investigations of new drugs clinically. The overall purpose of the study is to focus on the “Clinical Phase III Trial of Cancer” to prepare a management report with specific stages by concentrating on Clinical Trial Reports of Cancer and other relevant information.

Report on the trial

Define or Initiating

A Contract research organisation (CRO) has been involved in the project for designing to reduce the overall costs of the organisations for the development of new drugs and medicines in the niche market. The CRO involved in this trial mainly compares the effectiveness and safety of new medicines or drugs with the health of the public by providing services of clinical trial management. It has been observed that the main role of the CRO delves with coordination, planning, supervision and execution of the procedures involved in the clinical trial development (Ncbi.nlm.nih.gov, 2023). The CRO acts as the central point between the trial actors such as regulatory agencies, ethics committees, and hospitals along with the sponsors of the new drugs.

The Ethics Committee has been situated at academic or clinical institutions and hospitals and has been regarded as an independent body that had played a crucial role to ensure that the trial has been conducted with GCP guidelines (Ncbi.nlm.nih.gov, 2018). The committee also ensures safeguarding the well-being and safety of the participants involved solely in clinical trials. The overall purpose of the Ethics Committee in the Clinical Phase III trial of Cancer was to maintain and inspect the quality of the drugs in order to assess the significant relationship of the medicines with the treatment of patients. The Ethics Committee provides advice on moral questions regarding the clinical trial by educating the clinical staff on medical ethics issues, developing policies and others (Uofmhealth.org, 2023). It has been observed that the main purpose of the committee in this trial was to investigate solely the effectiveness of the new medicines identified for treating cancer on the health of the patients through revising and developing policies.

Clinical teams are associated with the Phase III trial of cancer in order to compare the treatments involved with cancer patients and the new medicine. The main role of clinical teams in the Phase III trial relates to the allocation of balance in the treatment procedures for enhancing its efficacy. The clinical team helps with setting up clinical sites, preparations of the regulatory submissions and ethics committee to evaluate the beneficial aspect of the new medicine. It also helps in providing training to the staff of the selected sites for the delivery of significant protocols and guidelines (Ncbi.nlm.nih.gov, 2017). The teams have helped in maintaining the oversight of the selected trial sites by taking appropriate actions for ensuring good recruitment and maintaining the timeline and quality of data collection procedures. It has been observed that the clinical teams in the Phase III trial of cancer have helped in maintaining the safety guidelines and protocols to make sure the beneficial aspects of the new medicine are on the cancer patients.

The site for conducting the Clinical Phase III trial of cancer has been selected as ClinicalTrials.gov. which helps in providing a results database and searchable registry for private clinical trials occurring around the world (Nih.gov, 2023). This site also provides the public with to access the overall information about the completed and ongoing clinical studies. It has been observed that clinical sites can be regarded as the sites where medical devices, therapies, drugs and medicines have been tested on human beings to analyse their efficacy and quality. The data observed in the clinical site has been used by sponsors for FDA approval of the products that help the public by answering important and critical questions.

Clinical trial feasibility facilitates the assessment of the capabilities of the investigators, the potential of the country to conduct the trial along with many other aspects with the involvement of executing clinical trials successfully. The clinical trial feasibility in relation to the Phase III trial of cancer has focused on regrowth rates, long-term safety, quality of life and analysis of oncological survival along with health economics (Ncbi.nlm.nih.gov, 2017a). The feasibility of the clinical trial has been an important factor as it helps in determining the site of patient populations, resources, collection procedures of data, experience as well as communication skills. The clinical trial feasibility in Phase III helps in the evaluation of the possibility of successful conduction of the clinical program. The feasibility helps in generating sufficient and accurate results for determining the effectiveness of each stage in clinical trial sections.

The IRB/EIC (Institutional review board/Ethics Institute Committee) help in reviewing the appropriateness and justifications of the trials of clinical protocols that define the benefits and risks of the participants involved in the study. It has been observed that in Phase III Clinical trials, the members of IRB help in assessing the ratio of benefit/risk (RBR) in the clinical trial of cancer. The IRB helps to ensure that the clinical trials related to cancer have been efficiently reviewed with the highest quality and ethical standards. The ratio of risk/benefit has been critically analysed for evaluating the effectiveness of the conducted clinical trials in the medical sections. The overall purpose of the IRB members ensures that the participants of clinical trials have been exposed towards minimal risks during the conduction of the trial for depicting the benefits observed from the results of the research.

Design or Planning

Phase III clinical trial has compared the effectiveness and safety of new treatment procedures against recent standard treatment. This kind of activity has been taken into consideration by doctors because they do not yet have any knowledge about which treatment provides better service or care to lead a normal lifestyle (Simpson et al. 2021). The “Cancer Clinical Trial Phase III” has been selected for this study. The main scope of this clinical trial would be highly effective because, with the help of this study, the entire process of implementing clinical trials has been observed from initiating to closing. The Ethics Committee and Clinical Team, Healthcare Professionals, Chemical Laboratory Experts and Research and Development team members are major stakeholders of this cancer clinical trial phase III.

A well-developed and designed project plan is essential for completing this clinical trial and it is also increasing the probability of clinical trial project management. It has supported effective management, and coherent organisation, facilitated transparency and detected foreseeable issues or problems by scrutinising the entire critical path of clinical trial projects (Spiegelberg et al. 2019). The development of cancer clinical trials is accurate for treating all those individuals who are suffering from cancer. The Randomised Control Trial has been selected for this study design. As a result, all those individuals have been selected who are living with this chronic disease and those individuals who are not suffering from cancer.

Preparation of working schedule

Table 1: Activities involved in Clinical Trial

(Source: Developed by the Researcher)

The above table has specified all activities which have been involved in the entire process of clinical trial phase III. Initially, pairing up with the Ethics Committee and Clinical Team for a clinical trial is an initial and crucial step. Planning a proper budget and collecting samples accurately for this clinical trial phase. Doing research on a specific drug is helpful for treating cancer and it is an effective step for accumulating information based on that specific drug which would be elected for the clinical trial. During sample management and creating a budget plan, some possible issues might occur (Bryson and George, 2020). It is also affecting the entire process of clinical trial website development and drug advertisement to promote the drug for treating cancer.

Sample Management is present in regulated bioanalysis and it is a major challenging and essential aspect for both non-clinical and clinical support. This is due to in fact samples would be compromised at any stage before analysis and the main outcome might be affected (Tie et al. 2022). Around 400 participants would be selected as the sample size for this clinical trial. All those participants would be patients suffering from cancer and other diseases. However, a lack of efficacy can occur difficulties in the clinical trial phase.

Minor discomfort and Lack of efficacy would be considered as major issues faced while involved in the clinical trial phase. According to the statement of Sun et al. (2022), it has been observed that nearly 40% to 50% of clinical trials have failed due to a lack of efficacy in clinical trials. Along with that, tremendous effort is devoted to enhancing the efficacy of clinical trial drugs in both clinical and preclinical studies. On the other hand, as expressed by Leister et al. (2022), during clinical trials, the selected participants are injured due to rays or chemicals or drugs. This kind of incident is affecting the participant's health and also it is reducing the efficiency of this cancer clinical trial phase III.

Communication Management is an essential step at the time of involvement in a clinical trial. By communicating with the Ethics Committee and Clinical Team, the entire process of a clinical trial would e completed properly. As stated by Mohile et al. (2020), communication is a vital tool for monitoring all possible ineffective communication in developing effective and potential solutions for proactively preventing negative consequences due to ineffective communication. Lastly, communication in clinical trials has resulted a way in which is also accessible for all individuals for creating trust for those results.

Quality Management is ensuring the integrity of collected clinical samples or data. As stated by Ferris et al. (2020), Quality assurance is facilitating continuous improvement in this clinical trial through the procedure and policy creation, internal audit, corrective support and preventive actions from the findings of the external audit. On the flip side, as expressed by Barrios and Mano, (2021), Statistical Analysis Plan is essential for creating a proper budget plan by which the clinical researchers are able to expend found according to their activities otherwise the clinical trial would be highly expensive. Around US$41 would be required for each patient for this cancer clinical trial phase III.

Patient Recruitment is important in clinical trials including some steps such as identifying potential resources of patients who are suffering from this health issue. Based on the perspective of Unger et al. (2019), it has been observed that patient recruitment in a clinical trial is included with comprehension to ensure and obtain information from the selected participants. In this phase, taking consent from the selected participants is another crucial step for collecting information from participants. On the other hand, Resources and Procurement is another step in this clinical trial. “Clinical Resource Management” is the ability for managing clinical trial resources which include staff in a clinical study, Contract Research Organisations, Patients and relationships, supplies and investigative sites. Apart from that, as expressed by Skivington et al. (2021), Staff Training is crucial for improving the efficacy of this clinical trial. Providing training to all clinical researchers who are involved in clinical trials is effective in reducing all possible risks during the cancer clinical trial phase III.

Conduct or Executing

Site start-up

It is one kind of organised meeting for discussing all new protocols prior to this clinical trial and it is also screening as well as enrolling potential patients. It is also playing as a role in training in clinical trials. In this phase, all researchers have studied whether this treatment is working or effective or not for treating cancer patients. As stated by McGranahan et al. (2019), all current and standard therapies and the safety of these treatments have been compared with the clinical trial. It also includes all individuals for making sure that those outcomes are valid. Moreover, all standard and current therapies have been compared with this clinical trial drug for providing proper treatment and care to cancer patients.

Recruitment and informed consent

Patient recruitment in clinical trials is an essential and crucial step to collect information from the selected participants. 400 participants would be accurate for this clinical trial and all those participants would be patients who are suffering from cancer and the control group. The clinical researchers would send consent to the selected participants for taking their consents whether they are interested in this trial or not. Moreover, in the consent form, those participants would have the right for withdrawing their participation in this clinical trial (Padilla et al. 2022). All participants would be informed about the main reason behind this clinical trial. It would be required to ensure that, the clinical researchers would not ask for any kind of personal information that they might not be given to answer. Those selected participants would withdraw their participants anytime whenever they want and in case they may face any kind of health issue at that clinical trial.

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Screening and enrolment

The screening procedure is evaluating all potential participants for identifying the eligibility for taking part in this study whereas, randomisation and enrolment process has registered in this clinical trial which assigns them, for providing accurate treatment to cancer patients (Janda et al. 2020). In this clinical trial, participants who need treatment for cancer have been selected and also screening those participants' health conditions who are suffering from are selected. Among those 400 participants, both control groups who are not suffering from cancer and affected patients who are living with cancer would be selected.

Patient visits

After involving all those participants, they would be provided with the invented drug to treat or combat the negative consequences of cancer in their bodies. After giving that invented drug, participants would be monitored and screened for at least 15 to 20 days. It would be fruitful for the clinical researchers to observe their selected participants for identifying any kind of symptoms after consuming the drug.

Sample Handling

After selecting samples or participants for this clinical trial, they would be observed for at least 15 to 20 days after giving or injecting that drug into their bodies. Moreover, all samples would be labelled properly with clear information based on their ID, time of sample collection and date. All those steps are crucial for remaining the ample intact at the time of sample storage.

Adherence monitoring

Adherence monitoring deals with maintaining the diaries of patients through direct observation of the clinical trials. It helps in table counting of the results of the trials by measuring the levels of medicines in urine and blood. It has been observed that adherence monitoring helps in investigating the overall effects related to smart monitoring through medication (O'Dwyer et al. 2020). It has been analysed that adherence monitoring in clinical trial III helps in maintaining the effectiveness and safety of the trial procedures. Moreover, adherence monitoring helps in understanding the medical conditions and treatments of cancer patients.

Adverse event reporting

Adverse reporting of the events in clinical trials helps in reporting the serious and significant adverse events every 24 hours for learning the events and sending the information to the sponsor (Chesney et al. 2020). It has been observed that advents event reporting deals with considering drug-related events that include the investigation or protocol brochure by including the overall assessments.

Protocol amendments

Protocol amendments help in submitting the proposals for carrying out a new investigation in the previously submitted reports (Getz et al. 2023). It has been observed that the Protocol amendments significantly deal with the safety of the new medicines or any changes prior to the clinical trial of Phase III. Protocol amendments have been considered to be changes in the clinical trials that have received regulatory approval.

Data collection and management

Data management and collection can be regarded as the procedures for collecting, managing and cleaning subjective data with compilation to regulatory standards (Hwang et al. 2019). The primary objective of this procedure is to provide high-quality data by reducing the number of missing data and errors by gathering maximised data for the analysis procedures. Data collection and management have been considered a critical factor in the clinical trial phase as it deals with the collection of the observed results from the research procedures to analyse the benefits and effectiveness of the new medicine for treating cancer patients.

Status report

Status reports have been considered to be procedures for submitting the actual observations of the trials that relate with new regulations along with new medical treatments. This report can be regarded as the largest confirmation by the committee or regulatory panel for accepting the new medicine by evaluating its safety standards. Thus, it has been analysed that the status reports helps the clinical trials to send the reports effectively to the regulatory committee for further procedures. The status reports help in deriving the overall success or failure of the clinical trial Phase III of cancer to determine the risks and benefits of the medicines to the health of the cancer patients.

Analyse or Monitoring

Clinical examination and the executive's framework can be viewed as the methodical review that has been utilized for assembling new medications for producing information to find as well as check Pharmacological, Clinical and unfavourable impacts alongside the goals to decide the viability and security of the new medications. The primary focal point of Clinical exploration the executives manages the coordination of patient consideration with the ultimate objective of treating patients with new and viable medications. It has been seen that the centre program of clinical examination the executives fundamentally covers the training and hypothesis of the statics, research strategies, legitimate and administrative structure that have been significant for examinations of new medications clinically. The general reason for the review is to zero in on the "Clinical Stage III Preliminary of Malignant growth" to set up an administration report with explicit stages by focusing on Clinical Preliminary Reports of Disease and other important data.

An Agreement research association (CRO) has been engaged with the undertaking for planning to lessen the general expenses of the associations for the improvement of new medications and drugs in the specialty market. The CRO engaged with this preliminary mostly analyses the adequacy and security of new meds or medications with the wellbeing of general society by offering types of assistance of clinical preliminary administration. It has been seen that the primary job of the CRO dives with coordination, arranging, management and execution of the methods associated with the clinical preliminary turn of events (Ncbi.nlm.nih.gov, 2023). The CRO goes about as the essential issue between the preliminary entertainers like administrative organizations, morals panels, and emergency clinics alongside the supporters of the new medications.

The Morals Panel has been arranged at scholarly or clinical establishments and medical clinics and has been viewed as a free body that played had a pivotal influence to guarantee that the preliminary has been led with GCP rules (Ncbi.nlm.nih.gov, 2018). The panel additionally guarantees shielding the prosperity and wellbeing of the members included exclusively in clinical preliminaries. The general motivation behind the Morals Council in the Clinical Stage III preliminary of Malignant growth was to keep up with and examine the nature of the medications to evaluate the critical relationship of the prescriptions with the treatment of patients.

Clinical groups are related with the Stage III preliminary of malignant growth to contrast the therapies in question and disease patients and the new medication. The principal job of clinical groups in the Stage III preliminary connects with the designation of equilibrium in the treatment techniques for improving its viability. The clinical group assists with setting up clinical destinations, arrangements of the administrative entries and morals board to assess the gainful part of the new medication. It likewise helps in giving preparation to the staff of the chose destinations for the conveyance of critical conventions and rules (Ncbi.nlm.nih.gov, 2017). The groups have helped in keeping up with the oversight of the chose preliminary destinations by making suitable moves for guaranteeing great enlistment and keeping up with the course of events and nature of information assortment systems. It has been seen that the clinical groups in the Stage III preliminary of malignant growth have helped in keeping up with the security rules and conventions to ensure the gainful parts of the new medication are on the disease patients.

The site for leading the Clinical Stage III preliminary of malignant growth has been chosen as ClinicalTrials.gov. which helps in giving an outcomes data set and accessible library for private clinical preliminaries happening all over the planet (Nih.gov, 2023). This site additionally gives people in general to get to the general data about the finished and continuous clinical examinations. It has been seen that clinical destinations can be viewed as the locales where clinical gadgets, treatments, medications and prescriptions have been tried on individuals to examine their viability and quality. The information saw in the clinical site has been utilized by patrons for FDA endorsement of the items that help the general population by responding to significant and basic inquiries.

Stage III clinical preliminary has analysed the adequacy and wellbeing of new treatment strategies against ongoing standard treatment. This sort of action has been thought about by specialists since they yet have no information about which treatment offers better support or care to lead a typical way of life (Simpson et al. 2021). The "Disease Clinical Preliminary Stage III" has been chosen for this review. The fundamental extent of this clinical preliminary would be exceptionally powerful in light of the fact that, with the assistance of this review, the whole course of executing clinical preliminaries has been seen from starting to shutting. The Morals Board of trustees and Clinical Group, Medical care Experts, Substance Lab Specialists and Innovative work colleagues are significant partners of this malignant growth clinical preliminary stage III.

An advanced and planned project plan is fundamental for finishing this clinical preliminary and it is likewise expanding the likelihood of clinical preliminary venture the executives. It has upheld successful administration, and intelligible association, worked with straightforwardness and recognized predictable issues or issues by investigating the whole basic way of clinical preliminary tasks (Spiegelberg et al. 2019). The advancement of disease clinical preliminaries is precise for treating that multitude of people who are experiencing malignant growth. The Randomized Control Preliminary has been chosen for this study plan. Thus, that large number of people have been chosen who are living with this constant infection and those people who are not experiencing malignant growth.

Test The board is available in managed bioanalysis and it is a significant testing and fundamental perspective for both non-clinical and clinical help. This is because of truth be told tests would be compromised at any stage before investigation and the principal result may be impacted (Tie et al. 2022). Around 400 members would be chosen as the example size for this clinical preliminary. That multitude of members would be patients experiencing malignant growth and different sicknesses. Nonetheless, an absence of viability can happen challenges in the clinical preliminary stage.

Conclude or Closing

Minor distress and Absence of adequacy would be considered as significant issues looked while engaged with the clinical preliminary stage. As per the assertion of Sun et al. ( 2022), it has been seen that almost 40% to half of clinical preliminaries have bombed because of an absence of viability in clinical preliminaries. Alongside that, enormous exertion is committed to upgrading the viability of clinical preliminary medications in both clinical and preclinical examinations. Then again, as communicated by Leister et al. ( 2022), during clinical preliminaries, the chose members are harmed because of beams or synthetic substances or medications. This sort of episode is influencing the member's wellbeing and furthermore it is diminishing the effectiveness of this malignant growth clinical preliminary stage III.

It is one sort of coordinated gathering for examining all new conventions preceding this clinical preliminary and it is screening as well as enlisting possible patients. It is likewise assuming as a part in preparing in clinical preliminaries. In this stage, all scientists have concentrated on regardless of whether this therapy is working or successful for treating malignant growth patients. As expressed by McGranahan et al. ( 2019), all current and standard treatments and the wellbeing of these medicines have been contrasted and the clinical preliminary. It additionally incorporates all people for ensuring that those results are legitimate. In addition, all norm and current treatments have been contrasted and this clinical preliminary medication for giving appropriate therapy and care to disease patients.

Subsequent to including that large number of members, they would be furnished with the imagined medication to treat or battle the adverse results of malignant growth in their bodies. Subsequent to giving that imagined drug, members would be checked and evaluated for something like 15 to 20 days. It would be productive for the clinical analysts to notice their chose members for distinguishing any sort of side effects in the wake of consuming the medication.

Convention changes help in presenting the recommendations for doing another examination in the recently submitted reports (Getz et al. 2023). It has been seen that the Convention alterations fundamentally manage the security of the new drugs or any progressions preceding the clinical preliminary of Stage III. Convention revisions have been viewed as changes in the clinical preliminaries that have gotten administrative endorsement.

Information the executives and assortment can be viewed as the methods for gathering, overseeing and cleaning emotional information with arrangement to administrative norms (Hwang et al. 2019). The essential target of this system is to give top notch information by diminishing the quantity of missing information and mistakes by get-together expanded information for the investigation methodology. Information assortment and the board have been viewed as a basic figure in the clinical preliminary stage as it manages the assortment of the noticed outcomes from the examination methods to break down the advantages and viability of the new medication for treating disease patients.

Conclusion

Status reports have been viewed as systems for presenting the genuine perceptions of the preliminaries that relate with new guidelines alongside new clinical medicines. This report can be viewed as the biggest affirmation by the board or administrative board for tolerating the new medication by assessing its security guidelines. Consequently, it has been dissected that the status reports assists the clinical preliminaries with sending the reports actually to the administrative advisory group for additional methodology. The status reports assist in determining the general achievement or disappointment of the clinical preliminary with staging III of malignant growth to decide the dangers and advantages of the meds to the strength of the disease patients.

References

Journals

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Websites

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