Review Article
Volume 8 Issue 2 - 2020
Clinical Trials in Oncology: A Comprehensive Review
Sumeet Singla1*, Diksha Sahai2 and Naveen Mangal3
1Pharmaceutical Sciences and Experimental Therapeutics, College of Pharmacy, University of Iowa, Iowa City, Iowa United States
2 College of Professional Studies, Northeastern University, Boston, USA
3 Clinical Pharmacologist, Boston, United States
*Corresponding Author: Sumeet Singla, Pharmaceutical Sciences and Experimental Therapeutics, College of Pharmacy, University of Iowa, Iowa City, Iowa United States.
Received: November 19, 2019; Published: January 11, 2020


Clinical trials are essential to the development of anti-cancer drugs and prolonging the survival of cancer patients. Cost of cancer care has increased over the years in the United States. Clinical trials for cancer differ than trials involving other diseases mainly due to the complexity of the disease. Low incidence rates of certain cancer types and rising clinical costs pose additional challenges in successful completion. Oncology trials are faced with practical and ethical concerns including the inefficiencies in trial execution, increasing use of off-label agents, increasing healthcare costs and increasing reliance on less robust trial designs. By elucidating the characteristics and outlining differences of oncology clinical trials from non-oncology clinical trials, we hope to provide a brief overview to our readers about the unique challenges faced during different phases of the drug development of anti-cancer drugs, as well as common features of clinical trials across the spectrum.

Keywords: Clinical Trials; Oncology


  1. Song Q., et al. "Cancer classification in the genomic era: five contemporary problems”. Human Genomics 9 (2015): 27. 
  2. Ananthakrishnan R., et al. "Design of oncology clinical trials: a review”. Critical Reviews in Oncology/Hematology 88.1 (2013): 144-153. 
  3. Ford JG., et al. "Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review”. Cancer 112.2 (2008): 228-242. 
  4. Grady C. "Institutional Review Boards: Purpose and Challenges”. Chest 148.5 (2015): 1148-1155. 
  5. Ciociola, A.A., et al. "How drugs are developed and approved by the FDA: current process and future directions”. The American Journal of Gastroenterology 109.5 (2014): 620-623. 
  6. Gombos A., et al. "Investigational drugs in early stage clinical trials for the treatment of HER2+ breast cancer”. Expert Opinion on Investigational Drugs 28.7 (2019): 617-627. 
  7. Mamounas EP., et al. "Use of letrozole after aromatase inhibitor-based therapy in postmenopausal breast cancer (NRG Oncology/NSABP B-42): a randomised, double-blind, placebo-controlled, phase 3 trial”. The Lancet Oncology 20.1 (2019): 88-99. 
  8. Zhang Y., et al. "Carbon Dioxide Laser Microsurgery versus Low-Temperature Plasma Radiofrequency Ablation for T1a Glottic Cancer: A Single-Blind Randomized Clinical Trial”. BioMed Research International (2018): 4295960. 
  9. Hoenemeyer TW., et al. "Open-Label Placebo Treatment for Cancer-Related Fatigue: A Randomized-Controlled Clinical Trial”. Scientific Reports 8.1 (2018): 2784. 
  10. Gad KT., et al. "Socioeconomic Differences in Referral to Phase I Cancer Clinical Trials: A Danish Matched Cancer Case-Control Study”. Journal of Clinical Oncology 37.13 (2019): 1111-1119. 
  11. Janelsins MC., et al. "Longitudinal Trajectory and Characterization of Cancer-Related Cognitive Impairment in a Nationwide Cohort Study”. Journal of Clinical Oncology (2018): JCO2018786624. 
  12. Wortmann JK., et al. "Use of complementary and alternative medicine by patients with cancer: a cross-sectional study at different points of cancer care”. Medical Oncology 33.7 (2016): 78. 
  13. Hirschfeld S. "The role of the fDA in cancer clinical trials”. Cancer Treatment and Research 132 (2007): 51-109. 
  14. Ivy SP., et al. "Approaches to phase 1 clinical trial design focused on safety, efficiency, and selected patient populations: a report from the clinical trial design task force of the national cancer institute investigational drug steering committee”. Clinical Cancer Research 16.6 (2010): 1726-1736. 
  15. Seymour L., et al. "The design of phase II clinical trials testing cancer therapeutics: consensus recommendations from the clinical trial design task force of the national cancer institute investigational drug steering committee”. Clinical Cancer Research 16.6 (2010): 1764-1769. 
  16. Glass HE., et al. "Are Phase 3 Clinical Trials Really Becoming More Complex?” Therapeutic Innovation and Regulatory Science 49.6 (2015): 852-860. 
  17. Chary KV. "Expedited drug review process: Fast, but flawed”. Journal of Pharmacology and Pharmacotherapeutics 7.2 (2016): 57-61. 
  18. Lara, P.N., Jr., et al. "Prospective evaluation of cancer clinical trial accrual patterns: identifying potential barriers to enrollment”. Journal of Clinical Oncology 19.6 (2001): 1728-1733. 
  19. Klabunde CN., et al. "Factors influencing enrollment in clinical trials for cancer treatment”. Southern Medical Journal 92.12 (1999): 1189-1193. 
  20. Taylor KM., et al. "Physicians' reasons for not entering eligible patients in a randomized clinical trial of surgery for breast cancer”. The New England Journal of Medicine 310.21 (1984): 1363-1367. 
  21. Enzler T., et al. "Clinical Trials in Pancreatic Cancer: A Long Slog”. Oncologist 22.12 (2017): 1424-1426. 
  22. Zhou Q., et al. "Cancer Clinical Trial Patient-Participants' Perceptions about Provider Communication and Dropout Intentions”. AJOB Empirical Bioethics 10.3 (2019): 190-200. 
  23. Halpern SD., et al. "The continuing unethical conduct of underpowered clinical trials”. Journal of the American Medical Association 288.3 (2002): 358-362. 
  24. Hrobjartsson A., et al. "Bias due to lack of patient blinding in clinical trials. A systematic review of trials randomizing patients to blind and nonblind sub-studies”. International Journal of Epidemiology 43.4 (2014): 1272-1283. 
  25. Macefield RC., et al. "A systematic review of on-site monitoring methods for health-care randomised controlled trials”. Clinical Trials 10.1 (2013): 104-124. 
  26. Jaguste VS. "Risk-based monitoring: Review of the current perceptions and toward effective implementation”. Perspectives in Clinical Research 10.2 (2019): 57-61. 
  27. In Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. National Academies Press: Washington (DC) (2010).
  28. Habib SL., et al. "Diabetes and risk of renal cell carcinoma”. Journal of Cancer 3 (2012): 42-48. 
  29. Sartor O., et al. "Independent data monitoring committees: an update and overview”. Urologic Oncology 33.3 (2015): 143-148. 
  30. Weckstein DJ., et al. "Assessment of perceived cost to the patient and other barriers to clinical trial participation”. Journal of Oncology Practice 7.5 (2011): 330-333. 
  31. Developing an investigator site budget for clinical trials”. Journal of Oncology Practice 3.2 (2007): 94-97. 
  32. Davis C., et al. "Desperately seeking cancer drugs: explaining the emergence and outcomes of accelerated pharmaceutical regulation”. Sociology of Health and Illness 33.5 (2011): 731-747. 
  33. Agarwal SK., et al. "Response Rates as Predictors of Overall Survival: A Meta-Analysis of Acute Myeloid Leukemia Trials”. Journal of Cancer 8.9 (2017): 1562-1567. 
  34. Mangal N., et al. "Relationship between response rates and median progression-free survival in non-Hodgkin's lymphoma: A meta-analysis of published clinical trials”. Hematological Oncology 36.1 (2018): 37-43. 
  35. Mangal, Naveen, et al. "Use of depth of response to predict progression‐free survival in relapsed or refractory multiple myeloma: Evaluation of results from 102 clinical trials." Hematological oncology 36.3 (2018): 547-553 
  36. Motzer RJ., et al. "Survival and prognostic stratification of 670 patients with advanced renal cell carcinoma”. Journal of Clinical Oncology 17.8 (1999): 2530-2540. 
  37. Blumenthal GM., et al. "Overall response rate, progression-free survival, and overall survival with targeted and standard therapies in advanced non-small-cell lung cancer: US Food and Drug Administration trial-level and patient-level analyses”. Journal of Clinical Oncology 33.9 (2015): 1008-1014. 
  38. Lesaffre E. "Superiority, equivalence, and non-inferiority trials”. Bulletin of the Hospital for Joint Diseases 66.2 (2008): 150-154. 
  39. Committee for Proprietary Medicinal P. "Points to consider on switching between superiority and non-inferiority”. British Journal of Clinical Pharmacology 52.3 (2001): 223-228. 
  40. Beecher HK. "Ethics and clinical research”. The New England Journal of Medicine 274.24 (1966): 1354-1360. 
  41. Hobbs BP., et al. "Bayesian Group Sequential Clinical Trial Design using Total Toxicity Burden and Progression-Free Survival”. The Journal of the Royal Statistical Society, Series C Applied Statistics 65.2 (2016): 273-297. 
  42. Kim WO. "Institutional review board (IRB) and ethical issues in clinical research”. Korean Journal of Anesthesiology 62.1 (2012): 3-12. 
  43. Massett HA., et al. "Meeting the Challenge: The National Cancer Institute's Central Institutional Review Board for Multi-Site Research”. Journal of Clinical Oncology 36.8 (2018): 819-824. 
  44. Parker GE. "A Framework for Navigating Institutional Review Board (IRB) Oversight in the Complicated Zone of Research”. Cureus 8.10 (2016): e844. 
  45. Satyanarayana Rao KH. "Informed consent: an ethical obligation or legal compulsion?" Journal of Cutaneous and Aesthetic Surgery 1.1 (2008): 33-35. 
  46. Manti S., et al. "How to obtain informed consent for research”. Breathe (Sheff) 14.2 (2018): 145-152. 
  47. Purcaru D., et al. "Informed consent: how much awareness is there?" PLoS One 9.10 (2014): e110139. 
  48. A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program., in A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program, SJ Nass, HL Moses, and J Mendelsohn, Editors. National Academies Press: Washington (DC) (2010).
  49. Ning N., et al. "Institutional Scientific Review of Cancer Clinical Research Protocols: A Unique Requirement That Affects Activation Timelines”. Journal of Oncology Practice 13.12 (2017): e982-e991. 
  50. Klitzman R. "Institutional review board community members: who are they, what do they do, and whom do they represent?" Academic Medicine 87.7 (2012): 975-981. 
Citation: Sumeet Singla and Naveen Mangal. “Clinical Trials in Oncology: A Comprehensive Review”. EC Psychology and Psychiatry 8.2 (2020): 01-11.

PubMed Indexed Article

EC Pharmacology and Toxicology
LC-UV-MS and MS/MS Characterize Glutathione Reactivity with Different Isomers (2,2' and 2,4' vs. 4,4') of Methylene Diphenyl-Diisocyanate.

PMID: 31143884 [PubMed]

PMCID: PMC6536005

EC Pharmacology and Toxicology
Alzheimer's Pathogenesis, Metal-Mediated Redox Stress, and Potential Nanotheranostics.

PMID: 31565701 [PubMed]

PMCID: PMC6764777

EC Neurology
Differences in Rate of Cognitive Decline and Caregiver Burden between Alzheimer's Disease and Vascular Dementia: a Retrospective Study.

PMID: 27747317 [PubMed]

PMCID: PMC5065347

EC Pharmacology and Toxicology
Will Blockchain Technology Transform Healthcare and Biomedical Sciences?

PMID: 31460519 [PubMed]

PMCID: PMC6711478

EC Pharmacology and Toxicology
Is it a Prime Time for AI-powered Virtual Drug Screening?

PMID: 30215059 [PubMed]

PMCID: PMC6133253

EC Psychology and Psychiatry
Analysis of Evidence for the Combination of Pro-dopamine Regulator (KB220PAM) and Naltrexone to Prevent Opioid Use Disorder Relapse.

PMID: 30417173 [PubMed]

PMCID: PMC6226033

EC Anaesthesia
Arrest Under Anesthesia - What was the Culprit? A Case Report.

PMID: 30264037 [PubMed]

PMCID: PMC6155992

EC Orthopaedics
Distraction Implantation. A New Technique in Total Joint Arthroplasty and Direct Skeletal Attachment.

PMID: 30198026 [PubMed]

PMCID: PMC6124505

EC Pulmonology and Respiratory Medicine
Prevalence and factors associated with self-reported chronic obstructive pulmonary disease among adults aged 40-79: the National Health and Nutrition Examination Survey (NHANES) 2007-2012.

PMID: 30294723 [PubMed]

PMCID: PMC6169793

EC Dental Science
Important Dental Fiber-Reinforced Composite Molding Compound Breakthroughs

PMID: 29285526 [PubMed]

PMCID: PMC5743211

EC Microbiology
Prevalence of Intestinal Parasites Among HIV Infected and HIV Uninfected Patients Treated at the 1o De Maio Health Centre in Maputo, Mozambique

PMID: 29911204 [PubMed]

PMCID: PMC5999047

EC Microbiology
Macrophages and the Viral Dissemination Super Highway

PMID: 26949751 [PubMed]

PMCID: PMC4774560

EC Microbiology
The Microbiome, Antibiotics, and Health of the Pediatric Population.

PMID: 27390782 [PubMed]

PMCID: PMC4933318

EC Microbiology
Reactive Oxygen Species in HIV Infection

PMID: 28580453 [PubMed]

PMCID: PMC5450819

EC Microbiology
A Review of the CD4 T Cell Contribution to Lung Infection, Inflammation and Repair with a Focus on Wheeze and Asthma in the Pediatric Population

PMID: 26280024 [PubMed]

PMCID: PMC4533840

EC Neurology
Identifying Key Symptoms Differentiating Myalgic Encephalomyelitis and Chronic Fatigue Syndrome from Multiple Sclerosis

PMID: 28066845 [PubMed]

PMCID: PMC5214344

EC Pharmacology and Toxicology
Paradigm Shift is the Normal State of Pharmacology

PMID: 28936490 [PubMed]

PMCID: PMC5604476

EC Neurology
Examining those Meeting IOM Criteria Versus IOM Plus Fibromyalgia

PMID: 28713879 [PubMed]

PMCID: PMC5510658

EC Neurology
Unilateral Frontosphenoid Craniosynostosis: Case Report and a Review of the Literature

PMID: 28133641 [PubMed]

PMCID: PMC5267489

EC Ophthalmology
OCT-Angiography for Non-Invasive Monitoring of Neuronal and Vascular Structure in Mouse Retina: Implication for Characterization of Retinal Neurovascular Coupling

PMID: 29333536 [PubMed]

PMCID: PMC5766278

EC Neurology
Longer Duration of Downslope Treadmill Walking Induces Depression of H-Reflexes Measured during Standing and Walking.

PMID: 31032493 [PubMed]

PMCID: PMC6483108

EC Microbiology
Onchocerciasis in Mozambique: An Unknown Condition for Health Professionals.

PMID: 30957099 [PubMed]

PMCID: PMC6448571

EC Nutrition
Food Insecurity among Households with and without Podoconiosis in East and West Gojjam, Ethiopia.

PMID: 30101228 [PubMed]

PMCID: PMC6086333

EC Ophthalmology
REVIEW. +2 to +3 D. Reading Glasses to Prevent Myopia.

PMID: 31080964 [PubMed]

PMCID: PMC6508883

EC Gynaecology
Biomechanical Mapping of the Female Pelvic Floor: Uterine Prolapse Versus Normal Conditions.

PMID: 31093608 [PubMed]

PMCID: PMC6513001

EC Dental Science
Fiber-Reinforced Composites: A Breakthrough in Practical Clinical Applications with Advanced Wear Resistance for Dental Materials.

PMID: 31552397 [PubMed]

PMCID: PMC6758937

EC Microbiology
Neurocysticercosis in Child Bearing Women: An Overlooked Condition in Mozambique and a Potentially Missed Diagnosis in Women Presenting with Eclampsia.

PMID: 31681909 [PubMed]

PMCID: PMC6824723

EC Microbiology
Molecular Detection of Leptospira spp. in Rodents Trapped in the Mozambique Island City, Nampula Province, Mozambique.

PMID: 31681910 [PubMed]

PMCID: PMC6824726

EC Neurology
Endoplasmic Reticulum-Mitochondrial Cross-Talk in Neurodegenerative and Eye Diseases.

PMID: 31528859 [PubMed]

PMCID: PMC6746603

EC Psychology and Psychiatry
Can Chronic Consumption of Caffeine by Increasing D2/D3 Receptors Offer Benefit to Carriers of the DRD2 A1 Allele in Cocaine Abuse?

PMID: 31276119 [PubMed]

PMCID: PMC6604646

EC Anaesthesia
Real Time Locating Systems and sustainability of Perioperative Efficiency of Anesthesiologists.

PMID: 31406965 [PubMed]

PMCID: PMC6690616

EC Pharmacology and Toxicology
A Pilot STEM Curriculum Designed to Teach High School Students Concepts in Biochemical Engineering and Pharmacology.

PMID: 31517314 [PubMed]

PMCID: PMC6741290

EC Pharmacology and Toxicology
Toxic Mechanisms Underlying Motor Activity Changes Induced by a Mixture of Lead, Arsenic and Manganese.

PMID: 31633124 [PubMed]

PMCID: PMC6800226

EC Neurology
Research Volunteers' Attitudes Toward Chronic Fatigue Syndrome and Myalgic Encephalomyelitis.

PMID: 29662969 [PubMed]

PMCID: PMC5898812

EC Pharmacology and Toxicology
Hyperbaric Oxygen Therapy for Alzheimer's Disease.

PMID: 30215058 [PubMed]

PMCID: PMC6133268

News and Events

September Issue Release

We always feel pleasure to share our updates with you all. Here, notifying you that we have successfully released the September issue of respective journals and can be viewed in the current issue pages.

Submission Deadline for October Issue

Ecronicon delightfully welcomes all the authors around the globe for effective collaboration with an article submission for the November issue of respective journals. Submissions are accepted on/before October 07, 2020.

Certificate of Publication

Ecronicon honors with a "Publication Certificate" to the corresponding author by including the names of co-authors as a token of appreciation for publishing the work with our respective journals.

Best Article of the Issue

Editors of respective journals will always be very much interested in electing one Best Article after each issue release. The authors of the selected article will be honored with a "Best Article of the Issue" certificate.

Certifying for Review

Ecronicon certifies the Editors for their first review done towards the assigned article of the respective journals.

Latest Articles

The latest articles will be updated immediately on the articles in press page of the respective journals.

Immediate Assistance

The prime motto of this team is to clarify all the queries without any delay or hesitation to avoid the inconvenience. For immediate assistance on your queries please don't hesitate to drop an email to