Outpatient healthcare and clinical trials in the care pathway: Organisational and regulatory aspects and tools*

Therapies ◽  
2022 ◽  
Author(s):  
Bruno Laviolle ◽  
Vincent Diebolt ◽  
Luc Duchossoy ◽  
Xavier Anglaret ◽  
Jehan-Michel Behier ◽  
...  
2020 ◽  
Vol 69 (6) ◽  
pp. 38-45
Author(s):  
Aleksandra Al'bertovna Taube

Author(s):  
Abhijeet Pandey ◽  
Ajinkya Nikam ◽  
Shreya Basavraj ◽  
Sadhana Mutalik ◽  
Divya Gopalan ◽  
...  

2022 ◽  
Vol 8 (4) ◽  
pp. 301-304
Author(s):  
Sunil Chaudhry ◽  
Vishwas Sovani

The aim of clinical research is to impart knowledge that will improve human health or improve understanding of human physiology. Although, till the end of 20 century pregnancy was always under exclusion criteria, now pervasive exclusion of pregnant women in clinical trials is currently not justified. Pregnancy brings in an array of anatomical, physiological and biochemical changes that can impact the pharmacokinetics of important medications. Pregnancy is often accompanied by chronic diseases like diabetes, hypertension, tuberculosis, HIV, depression which can require long term therapy. This indicates a need for studies being conducted exclusively in pregnant women. Current communication narrates ethical and regulatory aspects of inclusion of pregnant women in clinical trials.


Author(s):  
Laura Castillo-Saavedra ◽  
Suely Reiko Matsubayashi ◽  
Faiza Khawaja ◽  
John Ferguson ◽  
Felipe Fregni ◽  
...  

This chapter provides an overview of safety assessment in clinical trials, including challenges for designing and reporting studies measuring safety. Adverse events are undesirable, unfavorable, harmful, and unexpected effects resulting from a normal dosage of drug, medication, therapy, or any other intervention such as surgery. Monitoring of adverse events is critical to the patient’s safety (i.e., human subject’s protection) and data integrity in clinical trials. Moreover, this chapter reviews the regulatory aspects related to adverse events in clinical trials. Finally it presents a case discussion in which an unexpected adverse effect is detected and investigators need to determine whether this event is or is not related to the intervention and define a plan of action.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1881.1-1881
Author(s):  
K. Salama ◽  
N. Ramsundar ◽  
V. Joshi ◽  
M. K. Nisar

Background:Interstitial lung disease is a well described extra-articular manifestation in a range of rheumatic diseases. It carries significant morbidity and mortality. Management of rheumatic diseases associated ILD (r-ILD) requires expertise as the needs of such patients are complex and treatment options limited. Historically, such complex ILD has been managed in tertiary referral centres.Objectives:We set up a combined service incorporating both rheumatology and respiratory domains in a district general hospital (DGH) to help patients avoid long journeys and improve their experience whilst focusing on an integrated care pathway. We evaluated the outcomes of the first set of patients managed in this proof-of-concept service model.Methods:Referrals were accepted from any hospital specialist involved in the management r-ILD. They were triaged by lead ILD pulmonologist to monthly ILD MDT comprising a rheumatologist, respiratory physician, a radiologist and ILD specialist nurse. Appropriate patients were booked into combined clinic, run by the respective rheumatology and chest specialists with ILD interest, attracting a multi-speciality tariff. All the data was recorded electronically with full access to demographics, disease parameters, investigations and drug management.Results:89 patients were included in this proof-of-concept. Mean age was 66.1 yrs (19-90 yrs) and 44% (n=39) were male. 35 (40%) had RA, 34 (39%) had CTD, eight (10%) had sarcoidosis, five had IPAF and seven others. Most predominant HRCT pattern was NSIP (n=53,60%) followed by UIP (n=23, 21%), sarcoid (n=10, 12%) and miscellaneous (LIP and mixed). Mean FVC was 2.64 L/min (1.93-4.13) with DLCOc of 52.7% (28.9-90.1%) predicted. Only two patients had all antibodies negative whilst 87 had at least one antibody positive with ANA being the most common (n=28).Most (83%) patients were treated with immunomodulators including nine with rituximab. 39 (44.3%) patients had significant improvement in clinical, imaging and pulmonary parameters with DLCOc improving to 56.57% and FVC to 2.70 L/min. There were similar improvements in six minute walk test. 17 patients died and 20 patients required long term oxygen therapy.Conclusion:This proof-of-concept real world study confirms the utility of a combined specialist service in a district general hospital. Nearly half of this complex and resource intensive patient cohort had good clinical outcomes and derived benefit from the expertise in one room. Feedback from both patients and referrers was unanimously positive. No patient required tertiary centre referral and all could be managed adequately in the clinical setting.Our report confirms that r-ILD can be managed in a DGH setting with a stream-lined service offering clear benefits to patients. We would argue that r-ILD service, congruent to satellite pulmonary hypertension clinics in secondary care with hub-and-spoke model liaison with tertiary centre, can be established on similar principles and could help over-stretched tertiary care with repatriation of services whilst helping develop local expertise in the management of chronic ILD.Disclosure of Interests:Karim Salama: None declared, Natasha Ramsundar: None declared, Vijay Joshi: None declared, Muhammad Khurram Nisar Grant/research support from: Muhammad Nisar undertakes clinical trials and received support (including attendance at conferences, speaker fees and honoraria) from Roche, Chugai, MSD, Abbvie, Pfizer, BMS, Celgene, Novartis and UCB, Consultant of: Muhammad Nisar undertakes clinical trials and received support (including attendance at conferences, speaker fees and honoraria) from Roche, Chugai, MSD, Abbvie, Pfizer, BMS, Celgene, Novartis and UCB, Speakers bureau: Muhammad Nisar undertakes clinical trials and received support (including attendance at conferences, speaker fees and honoraria) from Roche, Chugai, MSD, Abbvie, Pfizer, BMS, Celgene, Novartis and UCB


Author(s):  
Heinz Drexel ◽  
Basil S Lewis ◽  
Giuseppe M C Rosano ◽  
Christoph H Saely ◽  
Gerda Tautermann ◽  
...  

Abstract This review article aims to explain the important issues that data safety monitoring boards (DSMB) face when considering early termination of a trial and is specifically addressed to the needs of clinical and research cardiologists. We give an insight into the overall background and then focus on the three principal reasons for stopping trials, i.e. efficacy, futility, and harm. The statistical essentials are also addressed to familiarize clinicians with the key principles. The topic is further highlighted by numerous examples from lipid trials and antithrombotic trials. This is followed by an overview of regulatory aspects, including an insight into industry–investigator interactions. To conclude, we summarize the key elements that are the basis for a decision to stop a randomized clinical trial (RCT).


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