Top Tweets for #StreamlineClinicalResearch
Even if this work by @JlgraciaMD has been around for a few months, it is more important than ever! And this thread is really a great summary of the overwhelming bureaucracy…
#StreamlineClinicalResearch
@OncoAlert 🚨
1/ Bureaucracy is overwhelming Clinical Research!
ESMO proposes principles to improve Sponsoring and Monitoring of Clinical Trials and promote patient welfare
Follow thread for examples & proposals, share if you agree!
#StreamlineClinicalResearch
@myESMO
https://t.co/IJZLyIrJAv
The increasing complexity and bureaucracy of clinical research is a threat to progress and is only getting worse. Great article @Annals_Oncology by @JlgraciaMD @TeresaSAmaral and more @myESMO highlights some of the major issues. #StreamlineClinicalResearch
https://t.co/tBk4vSssJL
I think this also fits very well into our discussion of the need 2
#StreamlineClinicalResearch
https://t.co/kwlNDofkgK
Central labs imply diff platforms, diff couriers, etc‼️Most importantly it adds to the TIME ⛔️ we need to wait before we can include pts in #clinicaltrial
Calls to action at #NYLCF23: Dr. @LuisPaz_Ares asks when can we remove central labs from clinical trials? We need to remove archaic overinterpretation of GCP like signing all labs and creating so many CRFs. @NYLungCancerFdn
Another example of actions that add to the #documentationburden
CRO requests documentation of normal range for age & gender ‼️ PI explains there is no normal range for such variables but must describe the situation in a NTF
#StreamlineClinicalResearch
https://t.co/kwlNDofkgK
The burden of bureaucracy in clinical research has increased for investigators & clinical research teams. ESMO proposes a framework to streamline clinical research & reduce the bureaucracy in clinical trials, promoting better care for cancer patients.
🔗https://t.co/QzKyv0kHv1
@MichaelDJain 8/ Use simplified delegation log templates. The investigator is responsible for maintaining the list of delegations (GCP 4.1.5) and should decide the format.
Typical delegation log template vs. proposed simplified template.
#StreamlineClinicalResearch
https://t.co/IJZLyIrJAv
@TeresaSAmaral @EllipsesCMO @LuisCB_MedPharm @MartijnLolkema @ViktorGruenwald @ruthvera_onco @JlgraciaMD What about regulatory authorities? They could also avoid excessive administrative burden that affect patient’s safety & rights & QoL
#StreamlineClinicalResearch
👇 Continue the discussion: share your thoughts on the below points
Great topic to balance efforts and keep your research team motivated. We need to:
👉 revise rules to conduct trials
👉 reduce & simplify without over-interpretation of GCP
👉 balance effort and value
#StreamlineClinicalResearch
@myESMO
@JlgraciaMD
The burden of bureaucracy in clinical research has increased for investigators & clinical research teams. ESMO proposes a framework to streamline clinical research & reduce the bureaucracy in clinical trials, promoting better care for cancer patients.
🔗https://t.co/QzKyv0kHv1
@TeresaSAmaral @myESMO Thanks to @TeresaSAmaral and ESMO Clinical Research Observatory team!
https://t.co/1FAREA5aer
Also thanks to @myESMO Executive Board and staff
@TaberneroJosep @peters_solange @AndresC27622123 @GPentheroudakis Klizia Marinoni
#StreamlineClinicalResearch
13/ Clinical interference: the protocol imposes decisions on patient care that diverge from best medical practice according to investigator.
Such situations, though infrequent, challenge GCP and may be harmful for the patient.
#StreamlineClinicalResearch
https://t.co/IJZLyIrJAv
12/ Pharmacovigilance:
"Reporting events unlikely caused by the drug is uninformative.
Reducing uninformative reports will allow sponsors FDA and investigators to focus on public health issues."
https://t.co/Pk6xbG8vHJ
#StreamlineClinicalResearch
11/ "The principal investigator receives 38 different pharmacovigilance reports from one single study in less than 24 hours. The events are not summarized, and none of them is prioritized over the others."
https://t.co/IJZLyIrJAv
#StreamlineClinicalResearch
10/Maximize task delegation to research team members
Monitoring and audits should only request administrative tasks required by GCP and legal regulations
Monitors should receive appropriate training in the disease (GCP 5.18.2)
#StreamlineClinicalResearch
https://t.co/IJZLyIrJAv
9/ Develop user-friendly electronic resources.
Avoid unnecessary training courses.
#StreamlineClinicalResearch
https://t.co/IJZLyIrJAv
8/ Use simplified delegation log templates. The investigator is responsible for maintaining the list of delegations (GCP 4.1.5) and should decide the format.
Typical delegation log template vs. proposed simplified template.
#StreamlineClinicalResearch
https://t.co/IJZLyIrJAv
7/Consent should be revised when important new information available may be relevant to the subject’s consent (GCP 4.8.2)
... consents should not be revised when the information is not relevant ...
#StreamlineClinicalResearch
https://t.co/IJZLyIrJAv
6/ Informed consent is documented by a written, signed and dated form (GCP 1.28)
Duplicating the process in the medical records is redundant, leads to errors and is noncompliant with GCP because they are not signed by patients
#StreamlineClinicalResearch
https://t.co/IJZLyIrJAv
5/ Investigators should only sign the essential documents required by GCP (section 8, table 1) and legal regulations (e.g.: conflicts of interest).
Use simplified templates.
#StreamlineClinicalResearch
https://t.co/IJZLyIrJAv
4/"The CRO requests to document normal range for age and gender of patients. The investigator explains that there is not a normal range for such variables but must describe the situation in a Note-to-file upon insistence of CRO"
#StreamlineClinicalResearch
https://t.co/IJZLyIrJAv
3/The increased burden of bureaucracy overwhelms research teams, generates frustration and loss of motivation of experienced investigators and decreases interest of young physicians to develop a clinical research career.
#StreamlineClinicalResearch
https://t.co/IJZLyIrJAv
2/ Over-interpretation and misinterpretation of regulations by sponsors and CROs have substantially increased the administrative burden, compromising the sustainability of clinical research.
#StreamlineClinicalResearch
https://t.co/IJZLyIrJAv
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