The biggest barrier to completing studies is the shortage of people who take part. All drug and many device trials target a subset of the population, meaning not everyone can participate. Some drug trials require patients to have unusual combinations of disease characteristics. It is a challenge to find the appropriate patients and obtain their consent, especially when they may receive no direct benefit because they are not paid, the study drug is not yet proven to work, or the patient may receive a placebo. Not all of these will prove to be useful, but those that are may be delayed in getting approved because the number of participants is so low.
For clinical trials involving potential for seasonal influences such as airborne allergies , seasonal affective disorder , influenza , and skin diseases , the study may be done during a limited part of the year such as spring for pollen allergies , when the drug can be tested. Clinical trials that do not involve a new drug usually have a much shorter duration. Exceptions are epidemiological studies, such as the Nurses' Health Study.
Clinical trials designed by a local investigator, and in the US federally funded clinical trials, are almost always administered by the researcher who designed the study and applied for the grant. Small-scale device studies may be administered by the sponsoring company. Clinical trials of new drugs are usually administered by a contract research organization CRO hired by the sponsoring company.
The sponsor provides the drug and medical oversight. A CRO is contracted to perform all the administrative work on a clinical trial. For phases 2, 3 and 4, the CRO recruits participating researchers, trains them, provides them with supplies, coordinates study administration and data collection, sets up meetings, monitors the sites for compliance with the clinical protocol, and ensures the sponsor receives data from every site. Phase 1 clinical trials of new medicines are often conducted in a specialist clinical trial clinic, with dedicated pharmacologists, where the subjects can be observed by full-time staff.
These clinics are often run by a CRO which specialises in these studies. At a participating site, one or more research assistants often nurses do most of the work in conducting the clinical trial. The research assistant's job can include some or all of the following: providing the local institutional review board IRB with the documentation necessary to obtain its permission to conduct the study, assisting with study start-up, identifying eligible patients, obtaining consent from them or their families, administering study treatment s , collecting and statistically analyzing data, maintaining and updating data files during followup, and communicating with the IRB, as well as the sponsor and CRO.
Janet Yang uses the Interactional Justice Model to test the effects of willingness to talk with a doctor and clinical trial enrollment. The reasoning behind this discovery may be patients are happy with their current care. Another reason for the negative relationship between perceived fairness and clinical trial enrollment is the lack of independence from the care provider. Results found that there is a positive relationship between a lack of willingness to talk with their doctor and clinical trial enrollment.
Lack of willingness to talk about clinical trials with current care providers may be due to patients' independence from the doctor. Patients who are less likely to talk about clinical trials are more willing to use other sources of information to gain a better insight of alternative treatments.
Clinical trial enrollment should be motivated to utilize websites and television advertising to inform the public about clinical trial enrollment. The last decade has seen a proliferation of information technology use in the planning and conduct of clinical trials. Clinical trial management systems are often used by research sponsors or CROs to help plan and manage the operational aspects of a clinical trial, particularly with respect to investigational sites.
Advanced analytics for identifying researchers and research sites with expertise in a given area utilize public and private information about ongoing research. Interactive voice response systems are used by sites to register the enrollment of patients using a phone and to allocate patients to a particular treatment arm although phones are being increasingly replaced with web-based IWRS tools which are sometimes part of the EDC system.
While patient-reported outcome were often paper based in the past, measurements are increasingly being collected using web portals or hand-held ePRO or eDiary devices, sometimes wireless. Access to many of these applications are increasingly aggregated in web-based clinical trial portals.
In , the FDA approved a phase 1 trial that used telemonitoring, also known as remote patient monitoring, to collect biometric data in patients' homes and transmit it electronically to the trial database. This technology provides many more data points and is far more convenient for patients, because they have fewer visits to trial sites. Clinical trials are closely supervised by appropriate regulatory authorities. All studies involving a medical or therapeutic intervention on patients must be approved by a supervising ethics committee before permission is granted to run the trial.
The local ethics committee has discretion on how it will supervise noninterventional studies observational studies or those using already collected data. To be ethical, researchers must obtain the full and informed consent of participating human subjects. One of the IRB's main functions is to ensure potential patients are adequately informed about the clinical trial. In California , the state has prioritized the individuals who can serve as the legally authorized representative.
In some US locations, the local IRB must certify researchers and their staff before they can conduct clinical trials. The International Conference of Harmonisation Guidelines for Good Clinical Practice is a set of standards used internationally for the conduct of clinical trials. The guidelines aim to ensure the "rights, safety and well being of trial subjects are protected". The notion of informed consent of participating human subjects exists in many countries all over the world, but its precise definition may still vary.
Informed consent is clearly a 'necessary' condition for ethical conduct but does not 'ensure' ethical conduct. In compassionate use trials the latter becomes a particularly difficult problem. The final objective is to serve the community of patients or future patients in a best-possible and most responsible way. See also Expanded access. However, it may be hard to turn this objective into a well-defined, quantified, objective function. In some cases this can be done, however, for instance, for questions of when to stop sequential treatments see Odds algorithm , and then quantified methods may play an important role.
Additional ethical concerns are present when conducting clinical trials on children pediatrics , and in emergency or epidemic situations. In response to specific cases in which unfavorable data from pharmaceutical company-sponsored research were not published, the Pharmaceutical Research and Manufacturers of America published new guidelines urging companies to report all findings and limit the financial involvement in drug companies by researchers.
Drug researchers not directly employed by pharmaceutical companies often seek grants from manufacturers, and manufacturers often look to academic researchers to conduct studies within networks of universities and their hospitals, e. Similarly, competition for tenured academic positions, government grants and prestige create conflicts of interest among academic scientists.
In the United States, all clinical trials submitted to the FDA as part of a drug approval process are independently assessed by clinical experts within the Food and Drug Administration,  including inspections of primary data collection at selected clinical trial sites. In , the editors of 12 major journals issued a joint editorial, published in each journal, on the control over clinical trials exerted by sponsors, particularly targeting the use of contracts which allow sponsors to review the studies prior to publication and withhold publication.
They strengthened editorial restrictions to counter the effect. Researchers may be restricted from contributing to the trial design, accessing the raw data, and interpreting the results. Responsibility for the safety of the subjects in a clinical trial is shared between the sponsor, the local site investigators if different from the sponsor , the various IRBs that supervise the study, and in some cases, if the study involves a marketable drug or device , the regulatory agency for the country where the drug or device will be sold.
For safety reasons, many clinical trials of drugs  are designed to exclude women of childbearing age, pregnant women, or women who become pregnant during the study. In some cases, the male partners of these women are also excluded or required to take birth control measures. Throughout the clinical trial, the sponsor is responsible for accurately informing the local site investigators of the true historical safety record of the drug, device or other medical treatments to be tested, and of any potential interactions of the study treatment s with already approved treatments.
This allows the local investigators to make an informed judgment on whether to participate in the study or not. The sponsor is also responsible for monitoring the results of the study as they come in from the various sites as the trial proceeds. In larger clinical trials, a sponsor will use the services of a data monitoring committee DMC, known in the US as a data safety monitoring board. This independent group of clinicians and statisticians meets periodically to review the unblinded data the sponsor has received so far.
The DMC has the power to recommend termination of the study based on their review, for example if the study treatment is causing more deaths than the standard treatment, or seems to be causing unexpected and study-related serious adverse events. The sponsor is responsible for collecting adverse event reports from all site investigators in the study, and for informing all the investigators of the sponsor's judgment as to whether these adverse events were related or not related to the study treatment.
The sponsor and the local site investigators are jointly responsible for writing a site-specific informed consent that accurately informs the potential subjects of the true risks and potential benefits of participating in the study, while at the same time presenting the material as briefly as possible and in ordinary language. FDA regulations state that participating in clinical trials is voluntary, with the subject having the right not to participate or to end participation at any time.
The ethical principle of primum non nocere "first, do no harm" guides the trial, and if an investigator believes the study treatment may be harming subjects in the study, the investigator can stop participating at any time. On the other hand, investigators often have a financial interest in recruiting subjects, and could act unethically to obtain and maintain their participation. The local investigators are responsible for conducting the study according to the study protocol, and supervising the study staff throughout the duration of the study.
In other words, they or their legally authorized representatives must give truly informed consent. Local investigators are responsible for reviewing all adverse event reports sent by the sponsor. These adverse event reports contain the opinion of both the investigator at the site where the adverse event occurred, and the sponsor, regarding the relationship of the adverse event to the study treatments. Local investigators also are responsible for making an independent judgment of these reports, and promptly informing the local IRB of all serious and study treatment-related adverse events.
When a local investigator is the sponsor, there may not be formal adverse event reports, but study staff at all locations are responsible for informing the coordinating investigator of anything unexpected. The local investigator is responsible for being truthful to the local IRB in all communications relating to the study. Approval by an Institutional Review Board IRB , or ethics board, is necessary before all but the most informal research can begin. In commercial clinical trials, the study protocol is not approved by an IRB before the sponsor recruits sites to conduct the trial.
However, the study protocol and procedures have been tailored to fit generic IRB submission requirements. In this case, and where there is no independent sponsor, each local site investigator submits the study protocol, the consent s , the data collection forms, and supporting documentation to the local IRB. Universities and most hospitals have in-house IRBs. Other researchers such as in walk-in clinics use independent IRBs. The IRB scrutinizes the study for both medical safety and protection of the patients involved in the study, before it allows the researcher to begin the study.
It may require changes in study procedures or in the explanations given to the patient. A required yearly "continuing review" report from the investigator updates the IRB on the progress of the study and any new safety information related to the study. In the US, the FDA can audit the files of local site investigators after they have finished participating in a study, to see if they were correctly following study procedures. This audit may be random, or for cause because the investigator is suspected of fraudulent data. Avoiding an audit is an incentive for investigators to follow study procedures.
A 'covered clinical study' refers to a trial submitted to the FDA as part of a marketing application for example, as part of an NDA or k , about which the FDA may require disclosure of financial interest of the clinical investigator in the outcome of the study. For example, the applicant must disclose whether an investigator owns equity in the sponsor, or owns proprietary interest in the product under investigation. The FDA defines a covered study as " Alternatively, many American pharmaceutical companies have moved some clinical trials overseas.
Benefits of conducting trials abroad include lower costs in some countries and the ability to run larger trials in shorter timeframes, whereas a potential disadvantage exists in lower-quality trial management. Beginning in the s, harmonization of clinical trial protocols was shown as feasible across countries of the European Union. At the same time, coordination between Europe, Japan and the United States led to a joint regulatory-industry initiative on international harmonization named after as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH  Currently, most clinical trial programs follow ICH guidelines, aimed at "ensuring that good quality, safe and effective medicines are developed and registered in the most efficient and cost-effective manner.
These activities are pursued in the interest of the consumer and public health, to prevent unnecessary duplication of clinical trials in humans and to minimize the use of animal testing without compromising the regulatory obligations of safety and effectiveness. Aggregating safety data across clinical trials during drug development is important because trials are generally designed to focus on determining how well the drug works. The safety data collected and aggregated across multiple trials as the drug is developed allows the sponsor, investigators and regulatory agencies to monitor the aggregate safety profile of experimental medicines as they're developed.
The value of assessing aggregate safety data is: a decisions based on aggregate safety assessment during development of the medicine can be made throughout the medicine's development and b it sets up the sponsor and regulators well for assessing the medicine's safety after the drug is approved. Clinical trial costs vary depending on trial phase, type of trial, and disease studied. The cost of a study depends on many factors, especially the number of sites conducting the study, the number of patients involved, and whether the study treatment is already approved for medical use.
The expenses incurred by a pharmaceutical company in administering a phase 3 or 4 clinical trial may include, among others:. In the US, sponsors may receive a 50 percent tax credit for clinical trials conducted on drugs being developed for the treatment of orphan diseases. In these cases, the investigator who writes the grant and administers the study acts as the sponsor, and coordinates data collection from any other sites. These other sites may or may not be paid for participating in the study, depending on the amount of the grant and the amount of effort expected from them.
Using internet resources can, in some cases, reduce the economic burden. Investigators are often compensated for their work in clinical trials. These amounts can be small, just covering a partial salary for research assistants and the cost of any supplies usually the case with national health agency studies , or be substantial and include 'overhead' that allows the investigator to pay the research staff during times between clinical trials. Participants in phase 1 drug trials do not gain any direct health benefit from taking part.
They are generally paid a fee for their time, with payments regulated and not related to any risk involved. In later phase trials, subjects may not be paid to ensure their motivation for participating with potential for a health benefit or contributing to medical knowledge. Small payments may be made for study-related expenses such as travel or as compensation for their time in providing follow-up information about their health after the trial treatment ends. Phase 0 and phase 1 drug trials seek healthy volunteers.
Most other clinical trials seek patients who have a specific disease or medical condition. The diversity observed in society should be reflected in clinical trials through the appropriate inclusion of ethnic minority populations. All volunteers being considered for a trial are required to undertake a medical screening. Requirements differ according to the trial needs, but typically volunteers would be screened in a medical laboratory for: . It has been observed that participants in clinical trials are disproportionately white. This may reduce the validity of findings in respect of non-white patients.
Depending on the kind of participants required, sponsors of clinical trials, or contract research organizations working on their behalf, try to find sites with qualified personnel as well as access to patients who could participate in the trial. Working with those sites, they may use various recruitment strategies, including patient databases, newspaper and radio advertisements, flyers, posters in places the patients might go such as doctor's offices , and personal recruitment of patients by investigators. Volunteers with specific conditions or diseases have additional online resources to help them locate clinical trials.
For example, the Fox Trial Finder connects Parkinson's disease trials around the world to volunteers who have a specific set of criteria such as location, age, and symptoms. The risk information seeking and processing RISP model analyzes social implications that affect attitudes and decision making pertaining to clinical trials.
Cancer patients reported more optimistic attitudes towards clinical trials than the general population. Having a more optimistic outlook on clinical trials also leads to greater likelihood of enrolling. From Wikipedia, the free encyclopedia. For the journal, see Clinical Trials journal. Main article: Phases of clinical research. Main article: Clinical study design. Main article: Clinical trial protocol.
- The Empire of Progress: West Africans, Indians, and Britons at the British Empire Exhibition, 1924–25!
- Pain: an Ambulance Perspective.
- In This Section.
- CoParenting Tips for StepMoms.
This section does not cite any sources. Please help improve this section by adding citations to reliable sources. Unsourced material may be challenged and removed.
- NIH Extramural Nexus!
- Nigerian Journal of Clinical Practice : Instructions for authors.
- Falling Women and Other Stories?
- Maya Studio Projects: Game Environments and Props.
- Tension Headache Relief -- Natural Remedies for Headaches that Work!!
- Related Content.
- The Spuddy (Bello).
November Learn how and when to remove this template message. Main article: Placebo-controlled studies. Main articles: Clinical research ethics and Clinical trials publication. Bill and Melinda Gates Foundation. Retrieved 1 January Journal of Health Economics.
The New York Times. Of the drugs started in clinical trials on humans, only 10 percent secure F. Powerful Medicines , pp. Alfred A. US Food and Drug Administration. Retrieved 2 October Annals of Surgery. World Journal of Methodology. Clinical trials: design, conduct, and analysis. The Harvard Medical School guide to men's health.
New York: Free Press. New York, NY: St. Martin's Press. Diffusion of Innovations. Page 7. Retrieved 9 September Clinical Trials in Oncology, Second Edition. CRC Press. Clinical Trials Handbook. Educational research: Planning, conducting, and evaluating quantitative and qualitative research 3rd. Retrieved 27 October Journal of Medical Biography. Retrieved 24 May Pharm Med. Archived from the original on 7 July Retrieved 5 January Retrieved 4 January Archived from the original on 14 March Basic Books. Cardiovascular Interventions. Anesthesia and Analgesia.
Retrieved 14 November Archived from the original on 10 April American Society of Clinical Oncology. Annual Meeting. Clinics in Dermatology. Pharm-Olam International. Archived from the original PDF on 15 July Retrieved 26 April Archived from the original on 4 February Retrieved 20 May Medical Law International. Redefining the relationships between doctors and drug companies. British Medical Journal. Archived from the original PDF on 25 June Retrieved 2 June Retrieved 22 May Current Medical Research and Opinion.
Aims and Scope
Annals of Internal Medicine. Food and Drug Administration. June Retrieved 16 October Retrieved 9 August Donker, M. Poortmans, P. Internal mammary and medial supraclavicular irradiation in breast cancer. Regional nodal irradiation in early-stage breast cancer. Thorsen, L. DBCG-IMN: a population-based cohort study on the effect of internal mammary node irradiation in early node-positive breast cancer. Recht, A.
Bhattacharya, I. Can interrogation of tumour characteristics lead us to safely omit adjuvant radiotherapy in patients with early breast cancer? Aristei, C. Lightowlers, S. Preoperative breast radiation therapy: indications and perspectives. Cancer 82 , — Baumann, P. Outcome in a prospective phase II trial of medically inoperable stage I non-small-cell lung cancer patients treated with stereotactic body radiotherapy.
Fakiris, A. Stereotactic body radiation therapy for early-stage non-small-cell lung carcinoma: four-year results of a prospective phase II study. Ricardi, U. Stereotactic body radiation therapy for early stage non-small cell lung cancer: results of a prospective trial. Lung Cancer 68 , 72—77 Timmerman, R. Stereotactic body radiation therapy for inoperable early stage lung cancer. JAMA , Videtic, G. Intensity-modulated radiotherapy-based stereotactic body radiotherapy for medically inoperable early-stage lung cancer: excellent local control. Stereotactic radiotherapy SABR for the treatment of primary non-small cell lung cancer; Systematic review and comparison with a surgical cohort.
Nagata, Y. Cassidy, R. Stereotactic body radiotherapy for early-stage non—small-cell lung cancer in patients 80 years and older: a multi-center analysis. Lung Cancer 18 , — Sun, B. Cancer , — Postmus, P. Palma, D. Impact of introducing stereotactic lung radiotherapy for elderly patients with stage I non—small-cell lung cancer: a population-based time-trend analysis. Dalwadi, S.
Practice patterns and outcomes in elderly stage I non-small-cell lung cancer: a to SEER analysis. Lung Cancer 19 , e—e Socinski, M. Cancer 92 , — Schild, S. Results of a phase I trial of concurrent chemotherapy and escalating doses of radiation for unresectable non—small-cell lung cancer. Bradley, J. Standard-dose versus high-dose conformal radiotherapy with concurrent and consolidation carboplatin plus paclitaxel with or without cetuximab for patients with stage IIIA or IIIB non-small-cell lung cancer RTOG : a randomised, two-by-two factorial phase 3 study.
Chun, S. Mulvenna, P. Dexamethasone and supportive care with or without whole brain radiotherapy in treating patients with non-small cell lung cancer with brain metastases unsuitable for resection or stereotactic radiotherapy QUARTZ : results from a phase 3, non-inferiority, randomised trial. Turrisi, A. Twice-daily compared with once-daily thoracic radiotherapy in limited small-cell lung cancer treated concurrently with cisplatin and etoposide.
Faivre-Finn, C. Concurrent once-daily versus twice-daily chemoradiotherapy in patients with limited-stage small-cell lung cancer CONVERT : an open-label, phase 3, randomised, superiority trial. Slotman, B. Prophylactic cranial irradiation in extensive small-cell lung cancer. Use of thoracic radiotherapy for extensive stage small-cell lung cancer: a phase 3 randomised controlled trial. Lancet , 36—42 Hamdy, F.
Widmark, A. Mason, M. Final report of the intergroup randomized study of combined androgen-deprivation therapy plus radiotherapy versus androgen-deprivation therapy alone in locally advanced prostate cancer. James, N. Peeters, S. Dose-response in radiotherapy for localized prostate cancer: results of the Dutch multicenter randomized phase III trial comparing 68 Gy of radiotherapy with 78 Gy.
Sign up for First Opinion
Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 randomised controlled trial. Escalated-dose versus control-dose conformal radiotherapy for prostate cancer: long-term results from the MRC RT01 randomised controlled trial. Morris, W. Wilkins, A. Hypofractionated radiotherapy versus conventionally fractionated radiotherapy for patients with intermediate-risk localised prostate cancer: 2-year patient-reported outcomes of the randomised, non-inferiority, phase 3 CHHiP trial. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial.
The Royal College of Radiologists. Incrocci, L. Hypofractionated versus conventionally fractionated radiotherapy for patients with localised prostate cancer HYPRO : final efficacy results from a randomised, multicentre, open-label, phase 3 trial. Lee, W. Randomized phase III noninferiority study comparing two radiotherapy fractionation schedules in patients with low-risk prostate cancer.
Catton, C. Randomized trial of a hypofractionated radiation regimen for the treatment of localized prostate cancer. Parker, C. Alpha emitter radium and survival in metastatic prostate cancer. Nilsson, S. Radiotherapy with or without chemotherapy in muscle-invasive bladder cancer. Hoskin, P. Radiotherapy with concurrent carbogen and nicotinamide in bladder carcinoma.
- Emotional Literacy: Intelligence with a Heart.
- Summary points.
- Five Little Pumpkins (A fun Halloween book for children).
- Clinical trial - Wikipedia.
- Looking for other ways to read this?.
MacFarlane, J. Mesorectal excision for rectal cancer. Kapiteijn, E. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer. Sebag-Montefiore, D. Glynne-Jones, R. Bosset, J. Chemotherapy with preoperative radiotherapy in rectal cancer. Preoperative radiotherapy with or without concurrent fluorouracil and leucovorin in T rectal cancers: results of FFCD Sauer, R.
Preoperative versus postoperative chemoradiotherapy for rectal cancer. Roh, M. Preoperative multimodality therapy improves disease-free survival in patients with carcinoma of the rectum: NSABP R Glimelius, B. Rectal cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Bujko, K. Long-term results of a randomized trial comparing preoperative short-course radiotherapy with preoperative conventionally fractionated chemoradiation for rectal cancer. Ngan, S. Randomized trial of short-course radiotherapy versus long-course chemoradiation comparing rates of local recurrence in patients with T3 rectal cancer: Trans-Tasman Radiation Oncology Group trial Flam, M.
Role of mitomycin in combination with fluorouracil and radiotherapy, and of salvage chemoradiation in the definitive nonsurgical treatment of epidermoid carcinoma of the anal canal: results of a phase III randomized intergroup study. Concomitant radiotherapy and chemotherapy is superior to radiotherapy alone in the treatment of locally advanced anal cancer: results of a phase III randomized trial of the European Organization for Research and Treatment of Cancer Radiotherapy and Gastrointestinal Cooperative Groups.
Northover, J. Epidermoid anal cancer: results from the UKCCCR randomised trial of radiotherapy alone versus radiotherapy, 5-fluorouracil, and mitomycin. Ajani, J. Fluorouracil, mitomycin, and radiotherapy vs fluorouracil, cisplatin, and radiotherapy for carcinoma of the anal canal: a randomized controlled trial. Peiffert, D.
James, R. EXTRA--a multicenter phase II study of chemoradiation using a 5 day per week oral regimen of capecitabine and intravenous mitomycin C in anal cancer. Kachnic, L. RTOG a phase 2 evaluation of dose-painted intensity modulated radiation therapy in combination with 5-fluorouracil and mitomycin-C for the reduction of acute morbidity in carcinoma of the anal canal. De Ruysscher, D. Eligibility for concurrent chemotherapy and radiotherapy of locally advanced lung cancer patients: a prospective, population-based study.
Access to innovative radiotherapy: how to make it happen from an economic perspective? Grau, C. Borras, J. Yap, M. Global access to radiotherapy services: have we made progress during the past decade? Jamison, D. Global health a world converging within a generation. Schwartz, C. Long-term survivors of childhood cancer: the late effects of therapy. Oncologist 4 , 45—54 McPartlin, A. MRI-guided prostate adaptive radiotherapy - a systematic review. Henke, L. Phase I trial of stereotactic MR-guided online adaptive radiation therapy SMART for the treatment of oligometastatic or unresectable primary malignancies of the abdomen.
Verkooijen, H. R-IDEAL: a framework for systematic clinical evaluation of technical innovations in radiation oncology. Front Oncol. Bibault, J. Personalized radiation therapy and biomarker-driven treatment strategies: a systematic review. Cancer Metastasis Rev. Forker, L. Biomarkers of tumour radiosensitivity and predicting benefit from radiotherapy. Tree, A. Stereotactic body radiotherapy for oligometastases.
Surveillance or metastasis-directed therapy for oligometastatic prostate cancer recurrence: a prospective, randomized, multicenter phase II trial. Goldstein, M. The DNA damage response: implications for tumor responses to radiation and chemotherapy. Van Limbergen, E. Combining radiotherapy with immunotherapy: the past, the present and the future. Chalmers, A. Science in focus: combining radiotherapy with inhibitors of the DNA damage response.
Kang, J. Current clinical trials testing the combination of immunotherapy with radiotherapy. Cancer 4 , 51 Marshall, R. Immune checkpoint inhibitors in lung cancer - an unheralded opportunity? Randomized trial of breast irradiation schedules after lumpectomy for women with lymph node-negative breast cancer. Cancer Inst. Agrawal, R. Venables, K.http://esportsify.net/love-comes-softly.php
Clinical trails | Clinical trails journal | Clinical Research - OAText
Winfield, E. Survey of UK breast radiotherapy techniques: background prior to the introduction of the quality assurance programme for the START standardisation of radiotherapy trial in breast cancer. Survey of tangential field planning and dose distribution in the UK: background to the introduction of the quality assurance programme for the START trial in early breast cancer.
Three-dimensional distribution of radiation within the breast: an intercomparison of departments participating in the START trial of breast radiotherapy fractionation. The use of in vivo thermoluminescent dosimeters in the quality assurance programme for the START breast fractionation trial. Verification films: a study of the daily and weekly reproducibility of breast patient set-up in the START trial. Hopwood, P. Comparison of patient-reported breast, arm, and shoulder symptoms and body image after radiotherapy for early breast cancer: 5-year follow-up in the randomised Standardisation of Breast Radiotherapy START trials.
Royal College of Radiologists. An overview. The influence of the boost in breast-conserving therapy on cosmetic outcome in the EORTC boost versus no boost trial. European Organization for Research and Treatment of Cancer. Senkus, E. Harris, E. Characterization of target volume changes during breast radiotherapy using implanted fiducial markers and portal imaging.
Evaluation of implanted gold seeds for breast radiotherapy planning and on treatment verification: a feasibility study on behalf of the IMPORT trialists. A multicentre observational study evaluating image-guided radiotherapy for more accurate partial-breast intensity-modulated radiotherapy: comparison with standard imaging technique. Bourez, R. Hurkmans, C. Association of Breast Surgery Trustees. A glance on quality assurance in EORTC study evaluating techniques for internal mammary and medial supraclavicular lymph node chain irradiation in breast cancer.
Cancer 39 , — Musat, E. Cancer 43 , — Excessive toxicity when treating central tumors in a phase II study of stereotactic body radiation therapy for medically inoperable early-stage lung cancer. National Comprehensive Cancer Network. Nyman, J. Groom, N.
e-book Clinical Trials; Your Key to Building a 7 Figure Practice
Is pre-trial quality assurance necessary? BMJ Open. Prophylactic cranial irradiation in extensive disease small-cell lung cancer: short-term health-related quality of life and patient reported symptoms: results of an international Phase III randomized controlled trial by the EORTC Radiation Oncology and Lung Cancer Groups.
What is the optimal radiotherapy schedule for limited stage small cell lung cancer? Lung Cancer , 52—53 Haslett, K. Management of patients with extensive-stage small-cell lung cancer: a European survey of practice. Patrice, G. Cost-effectiveness of thoracic radiation therapy for extensive-stage small cell lung cancer using evidence from the chest radiotherapy extensive-stage small cell lung cancer trial CREST. Prostate Cancer: Diagnosis And Management.
London: NICE, Seddon, B. Target volume definition in conformal radiotherapy for prostate cancer: quality assurance in the MRC RT trial. Acute and late complications after radiotherapy for prostate cancer: results of a multicenter randomized trial comparing 68 Gy to 78 Gy. Aluwini, S. Hypofractionated versus conventionally fractionated radiotherapy for patients with prostate cancer HYPRO : acute toxicity results from a randomised non-inferiority phase 3 trial.
Hypofractionated versus conventionally fractionated radiotherapy for patients with prostate cancer HYPRO : late toxicity results from a randomised, non-inferiority, phase 3 trial. American Urological Association. Accessed 3 Nov Hypofractionated radiotherapy for localized prostate cancer. Sartor, O. Effect of radium dichloride on symptomatic skeletal events in patients with castration-resistant prostate cancer and bone metastases: results from a phase 3, double-blind, randomised trial. Huddart, R. McDonald, F. Defining bowel dose volume constraints for bladder radiotherapy treatment planning.
Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer: year follow-up of the multicentre, randomised controlled TME trial. Marijnen, C. Acute side effects and complications after short-term preoperative radiotherapy combined with total mesorectal excision in primary rectal cancer: report of a multicenter randomized trial.
Impact of short-term preoperative radiotherapy on health-related quality of life and sexual functioning in primary rectal cancer: report of a multicenter randomized trial. Lange, M. Urinary dysfunction after rectal cancer treatment is mainly caused by surgery. Risk factors for sexual dysfunction after rectal cancer treatment. Cancer 45 , — Kusters, M. Patterns of local recurrence in rectal cancer; a study of the Dutch TME trial. Wiltink, L. Health-related quality of life 14years after preoperative short-term radiotherapy and total mesorectal excision for rectal cancer: report of a multicenter randomised trial.
Cancer 50 , — Chen, T. Bowel function 14 years after preoperative short-course radiotherapy and total mesorectal excision for rectal cancer: report of a multicenter randomized trial. Colorectal Cancer 14 , — Long-term health-related quality of life in patients with rectal cancer after preoperative short-course and long-course chemo radiotherapy.
Colorectal Cancer 15 , e93—e99 Quirke, P. Stephens, R. Best time to assess complete clinical response after chemoradiotherapy in squamous cell carcinoma of the anus ACT II : a post-hoc analysis of randomised controlled phase 3 trial. Tumour- and treatment-related colostomy rates following mitomycin C or cisplatin chemoradiation with or without maintenance chemotherapy in squamous cell carcinoma of the anus in the ACT II trial. Clinical endpoints in trials of chemoradiation for patients with anal cancer. Gunderson, L.