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Challenges in clinical research
The document discusses the complexities and challenges of conducting clinical research, highlighting the roles of various stakeholders, funding issues, ethics, and the need for collaboration among multidisciplinary teams. It emphasizes the importance of experience and knowledge in navigating internal and external challenges, as well as the financial and bureaucratic hurdles faced in large-scale trials. The document also touches on cultural differences and the ethical considerations necessary within clinical trials.
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Challenges in clinical research
- 1. Challenges in clinicalresearch NIKLAS NIELSEN, MD, PHD, HELSINGBORG, LUND UNIVERSITY
- 2. Disclosure and rationale •I have been principal investigator of one published clinical trial • One more will soon start
- 3. Complexity of alarge clinical trial • 10 countries, 36 sites, 250 investigators, 950 patients • 14-16 countries, 70-90 sites, 500 investigators, 1900 patients • Patients, relatives, investigators, clinicians, clinical trial units, managers, R and D units, ethical boards, data safety committees, industry and pharmaceutical companies, drug agencies, monitors, data platform providers, hospital lawyers, insurance companies, funders, academic societies, competing groups, journals, peer reviewers, colleges, family and friends
- 4. JNK/SAPK MAPKs Pro-death Activity RTK Ras Raf MAPK ERK Pro- Survival Activity PLCg PI3-K PKC Growth Factors Stress Signals PKB PCD Hourto Days Ischemia-reperfusion injury
- 5. Clinical trials areoften one off projects
- 6. Industry versus Investigatorinitiated! • A world of a difference!
- 7. Internal and externalvalidity
- 8. Internal and externalchallenges
- 9. CHALLENGES • INTERNAL • Knowledge •Experience • Status • Structure • Internal fear…. • EXTERNAL • Funding • Ethics • Insurance • Monitoring • Agreements • Culture • Pharmaceutical interventions • The world around!
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- 11. Knowledge • You probablyhave a research interest… • You must get to know your field… • If there is no systematic review available, perform one! • Post knowledge gaps in databases (DUETs, SBU, others) • Try to team up with an observational registry to get to know the essential basics – Frequency of the disease of interest – Background event rate of the outcome of interest – Variability of the outcome – Major independent predictors of the outcome – Number of patients in specific hopsitals/regions – Etc, etc
- 12. Experience • With experienceyou will know what challenges will face you • If you have limited experience, team up with someone who knows what to do – Clinical Research Unit – Statisticians – Methodologists – Experienced trialists
- 13. Guidelines will helpyou! equator-network.org
- 14. Status • Some brasswill also help! • Take advantage of a Bigwig!
- 15. Structure • Find youraccomplices! • Build networks (nationally/internationally) • Multi-diciplinary work force – Clinicians » Various specialities and professions – Trialists – Statisticians – Health economists – Clinical trial managers – Trial unit/CRO – Mentors
- 16. Internal fear andconscience….
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- 18. Funding • A largescale multicenter international industry sponsored trial may cost multiples of 10th of M Euro
- 20. Funding • A largescale multicenter international industry sponsored RCT may cost multiples of 10th of M Euro • A large investigator led RCT may have a budget of 2-3 M Euro • Same standards should anyway be met (GCP) • Infrastructure at hospitals and institutions must be financed • A large gap between what would be ideal and what is realistic • Reimbursement to sites lower than actual costs • Some diesease will attract funding easier…
- 21. Luke 19:26 • ”Itell you, whoever has, will be given more….”
- 22. Catch 22 situation… •Some funders will only give money if the trial can prove it is fully funded • You will only become fully funded when you receive the money • You ask for 100% and receive 50-70% • Money is given for certain periods of time • Money starts to go stale and disappear before the project has started • …and then you aren’t fully funded anymore…. • ”Yes, we are fully funded, but actually we need more….”
- 23. Academic currency • Steeringgroup positions • Author positions • Possibility to perform additional research • Publications, Impact Factor, H-index, Research-Gate-score…..
- 24. Ethics and consent •Etchical application processes vary significantly • Local Institutional Review Boards, Regional Ethical Committees, Central Ethical Committees • The view of what should be regarded as part of an ethical review vary • Special challenge in intensive and emergency care
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- 29. Insurance • Hundreds ofthousand of euro for insurance certificates • Hundreds of millions in reimbursements • Many providers/insurance companies, difficult to assess the differences • Limited interest in investigator led trials
- 30. Monitoring • External examinationof trial conduct – Screening, inclusion logs – Source data verification – Legal documents in order – List of investigators • Previously neglected area • Today mandatory • Time consuming • Expensive
- 31. Agreements • Sponsor issuestemplate approved by legal department • Site reads and amends after discussions with their legal people • Sponsor has another round of legal counseling • Sites reads and amends… • People very far from the trial will sign the important signatures • THIS CONSUMES TIME!
- 32. Agreements and lawtext • Sponsor (the “Indemnifying Party”) shall indemnify, defend and hold harmless the PC, its trustees, officers, employees, agents and representatives (collective, the “PC Indemnitees”) from and against any and all losses, liability, cost and expenses, including attorney’s fees and costs, awards, judgments, damages, fines, penalties, claims and causes of action (collectively, “Claims”) arising out of or related to the negligent acts or omissions of the Indemnifying Party or any of its officers, directors, employees, agents, representatives, contractors, successors, assigns or anyone acting on their behalf in connection with, arising from or related to the performance of obligations under this Agreement, including Claims for (i) personal injury, including death, and damage to property, (ii) the breach by the Indemnifying Party of any term, representation, warranty or covenant under this Agreement, or (iii) the use by Indemnifying Party of the research results provided hereunder.
- 33. Culture • Swedes can’tfollow command • A consultant from country X may think that one of the interventions is better • Email communication is difficult • In some countries you say ”yes”, but mean ”no” • Biobanking is not always so easy • Some colleges can’t understand why it is impossible to have a beer with the lunch payed by the Research Council • Sometimes you should just not crack that joke…
- 34. The world around… •You have to realize that you may be criticized! – Colleges (Clinicians, fellow researchers) – Authorities – Patient organizations – Industry
- 35. Standard care andguideline wordings… • Guidelines are mostly needed when we don’t know what to do • Strong recommendations and wording of guidelines will influence what would be considered standard practice • Established standard practice is hard to randomize against • Guideline text may therefore lead to stagnation and dogma • Ought to be compulsory to include areas of uncertainty
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- 37. Internal fear andconscience…. • Are we causing harm? • Random care versus randomized allocation of care….
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