2023-01-24 13:25:00

ACCP Position Statement: "The Importance of Participant Tracking When Conducting Clinical Pharmacology Drug Trials"

Logo PR Newswire
PR Newswire

ASHBURN, Va., Jan. 24, 2023 /PRNewswire/ -- The American College of Clinical Pharmacology® (ACCP) published a Position Paper entitled "The Importance of Participant Tracking When Conducting Clinical Pharmacology Drug Trials". This paper brings awareness to the need for improved clinical pharmacology trial tracking and management to optimize the safety of the participants and ensure the continued scientific rigor of the clinical trial process. ACCP strongly recommends the use of research participant databases, registries or independent monitoring organizations to oversee the recruitment and enrollment of participants. As all clinical research trials involve a level of risk, it is the ethical responsibility of Sponsors, Ethical Review Boards and Researchers for these trials to ensure this risk is minimized and participant safety maximized, to the extent possible based on the available data at that time. It is therefore paramount that those participating in the clinical trial fully meet the inclusion and exclusion criteria set forth in the protocol and be truthful regarding previous clinical trial experience during the screening phase of the trial. The cost of participant deception may directly affect the safety of those involved. Additionally, such actions may also compromise the validity of these trials and the future regulatory approval or rejection of the therapy. Enrollment of individuals that do not properly disclose prior clinical trial participation or are purposely deceptive during the screening & enrollment periods can create a complex scenario impacting the identification and accurate reporting of safety events and kinetic and dynamic interactions.

ACCP strongly advocates for the need of a harmonized method or system to track participant enrollment in clinical pharmacology research studies. The use of such a method or system would support the current efforts of clinical researchers to ensure safe participation, help mitigate participant exploitation, prevent abuse of the enrollment process and maximize the scientific integrity of these studies. In the absence of a federally established modality, ACCP recommends the use of independent research subject databases, registries or organizations when conducting these studies to oversee the proper enrollment of its participants. ACCP also stresses the need for improved participant awareness concerning the potential safety risks when volunteers enroll into multiple research studies simultaneously or concurrently.

About ACCP

ACCP is a non-profit association providing accredited Continuing Education, publications and career-enhancing opportunities to clinical pharmacology healthcare professionals.

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/accp-position-statement-the-importance-of-participant-tracking-when-conducting-clinical-pharmacology-drug-trials-301725165.html

SOURCE American College of Clinical Pharmacology

Logo Daily Mail
HealthBy Kate Pickles2023-01-24 00:05:46
Women and patients on a higher number of medicines are at greater risk of suffering an adverse drug reaction, a study found. More than a quarter of people on...

Logo PR Newswire
HealthPress Release2023-01-18 13:25:00
ASHBURN, Va., Jan. 18, 2023 /PRNewswire/ -- The American College of Clinical Pharmacology® (ACCP) published a Position Paper entitled "The Importance of...

Logo GlobeNewswire
SciencePress Release2023-01-24 13:00:00
- Adverse events were reported in patients who took the second, middle-of-the-night dose of immediate-release oxybate less than 2.5 hours after the first...

Logo PR Newswire
HealthPress Release2023-01-24 13:00:00
FDA's Decision Forthcoming for Innovative Test with Agency's Breakthrough Device Designation ST. LOUIS, Jan. 24, 2023 /PRNewswire/ -- Geneoscopy Inc., a life...

Logo EIN Presswire
Growth of the U.S. interventional cardiology market is primarily driven by the diagnostic and interventional procedures performed, which are largely...

Logo Benzinga
Business / FinanceBy Globe Newswire2023-01-23 23:55:27
Receives greenlight from the FDA for Phase 1/2a clinical trial of CNA3103 On track to commence patient enrollment during the first half 2023 ADELAIDE,...

Logo PR Newswire
HealthPress Release2023-01-23 16:00:00
NEW YORK, Jan. 23, 2023 /PRNewswire/ -- In-depth analysis provided in the report includes: Current and future market trends to highlight market conditions...

Logo GlobeNewswire
SciencePress Release2023-01-23 18:25:00
Announced Earlier Today -Notice Received from ANDA Filer for FIRDAPSE CORAL GABLES, Fla., Jan. 23, 2023 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc....

Logo GlobeNewswire
SciencePress Release2023-01-24 13:00:00
BOSTON, Jan. 24, 2023 (GLOBE NEWSWIRE) -- Cerevance, a private, clinical-stage drug discovery and development company focused on central nervous system (CNS)...

Logo The Business Journals
Technology2023-01-23 19:47:07
Genetesis has added three new executives to its team as it nears a key FDA approval.

Logo EIN Presswire
HealthPress Release2023-01-23 13:38:17
Emergen Research Logo Increasing number of drug relapse and drug resistance cases and application of QSP in drug development processes are some key factors...

Logo Benzinga
Business / FinanceBy Pr Newswire2023-01-24 12:00:00
New Alberta regulations increase the need to educate doctors, psychiatrists, and nurse practitioners. CALGARY, AB, Jan. 24, 2023 /CNW/ - ATMA Journey Centers...

Logo Daily Mail
HealthBy Kate Pickles2023-01-24 00:05:49
Patients at surgeries with a high turnover of GPs are more likely to need emergency hospital treatment than those with steady care, a study has found. Family...

Logo NewsFileCorp
Press Release2023-01-24 12:30:00
Study Has Potential to Lead to In-Licensing Agreement and Accelerated Pathway to Phase II Toronto, Ontario--(Newsfile Corp. - January 24, 2023) - Awakn Life...

Logo PR Newswire
HealthPress Release2023-01-24 13:07:00
The study will evaluate repeat low doses of psilocybin for safety, tolerability, and efficacy in treating generalized anxiety disorder (GAD) on a take-home...

Logo Global News
HealthBy Megan King2023-01-24 10:00:55
A Nova Scotia paramedic is speaking out about the conditions those in his profession are facing as paramedics are becoming essential to “hallway medicine”...

Logo PR Newswire
TechnologyPress Release2023-01-23 23:35:00
South Australia's Commission on Excellence and Innovation in Health and SA Health have partnered with The Clinician to implement a digital solution for the...

Logo EIN Presswire
HealthPress Release2023-01-23 11:32:58
Douglas Insights Next Gen Healthcare Inc., Koninklijke Philips N.V. (Royal Philips), IBM Corporation, Agfa-Gevaert Group, Wolters Kluwer N.V. are some of the...

Logo PR Newswire
HealthPress Release2023-01-23 22:00:00
DUBLIN, Jan. 23, 2023 /PRNewswire/ -- The "Ovarian Cancer Drugs Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2017-2027 Segmented...

Logo Benzinga
Business / FinanceBy Pr Newswire2023-01-24 12:36:00
Treatment IDE Will Provide Opportunity to Treat Additional Patients in the US SAN RAMON, Calif., Jan. 24, 2023 /PRNewswire/ -- BioVentrix, Inc., a privately...