Clinical trials involving controlled drugs are complex and highly regulated requiring researchers to pay close attention to detail to ensure the safety of participants and the validity of the data. Here are ten essential points to consider when conducting a clinical trial involving controlled drugs:

1. Compliance with Local Laws & Regulations

• Compliance with local laws and regulations is essential for any clinical trial. For clinical trials involving controlled drugs, it is even more critical to follow all relevant regulations and obtain the necessary permits and approvals before starting the trial.

2. Strong Protocol

• A strong protocol is the cornerstone of any clinical trial. A well-written protocol outlines the study objectives, inclusion and exclusion criteria, drug administration, dosage, and monitoring procedures. A comprehensive protocol can help prevent errors and ensure that the trial is conducted safely and effectively.

3. Secure Supply Chain

• Using a secure supply chain for controlled drugs is crucial to ensure that the drugs are genuine, correctly labeled, and stored in compliance with local regulations. Documenting all steps in the supply chain can help ensure traceability and prevent the use of counterfeit drugs. One such way to do so, if using a wholesale drug distributor is to check the National Association of Boards of Pharmacy (NABP) website to see if your distributor is accredited. Distributors that have achieved Drug Distributor Accreditation (DDA) must meet and adhere to strict standards of quality and supply chain integrity. Check to see if your distributor is accredited here.

4. Staff Training & Proper Drug Disposal

• Training staff involved in the trial is essential to ensure that they are familiar with handling-controlled drugs, administering them, monitoring participants, and disposing of drugs safely. Disposing of drugs in a safe, secure, and compliant manner is crucial to mitigate drug diversion risks.
• One such way to dispose of Controlled Substances is via the use of chemical digestion products such as Rx Destroyer. Complying with the DEA non-retrievable standard found in 21 CFR 1317.90(a) and the EPA’s 40 CFR 266 Subpart P, Rx Destroyer is a fast-acting, ready-to-use formula that begins neutralizing medications on contact. Integrating an Rx Destroyer drug disposal system into an existing pharmaceutical or clinical trial setting is easy, cost effective, and perhaps the most comprehensive solution in preventing drug abuse and drug diversion in an environmentally conscious manner. See the 64 oz. All-Purpose Starter Kit w/ a wall mounted lock box here.
• For training in drug diversion prevention, check out the National Association of Drug Diversion Investigators (NADDI) here.

5. Monitoring Adverse Events

• Monitoring patients for adverse events is critical in clinical trials involving controlled drugs. Adverse events must be documented appropriately, and there should be a clear plan for managing adverse events. Staff must be familiar with the plan to respond appropriately in case of any adverse events. If an adverse event occurs it is imperative that a timely report be made to the Food and Drug Administration (FDA). Information on when and how to report adverse events to the FDA in connection with an approved Investigational New Drug (IND) application can be obtained here.

6. Implement a Double-Check System

• Implementing a double-check system can help prevent errors in administering drugs to participants. The system ensures that the correct drug is given to the right patient at the correct dosage, ensuring patient safety.

7. Accurate Record-Keeping

• Keeping accurate and comprehensive records of all aspects of the trial is essential. Records should include, but may not be limited too tracking drug administration, records of drug inventory, records for drug disposal, the documenting of adverse events, and other record necessary to ensure that the trial is conducted in compliance with federal, state, and local rules/regulations. Researchers should pay close attention to Drug Enforcement Administration (DEA) regulations if the trial involves controlled substance. These can be found in 21 CFR 1300-END and may be accessed here.

8. Appropriate Blinding & Randomization

• Randomizing participants to receive either the drug or a placebo and blinding patients, investigators, and data analysts to the treatment assignment helps prevent bias and ensures the validity of the trial results.

9. Patient Confidentiality

• Maintaining patient confidentiality is essential in any clinical trial, but it is even more critical in trials involving controlled drugs. Unique patient identifiers should be used instead of patient names, and patient records should be stored in a secure location.

10. Plan for The End of The Trial

• Developing a clear plan for the end of the trial is essential. The plan should include data analysis and publication of the trial results. There should also be clear guidelines on disposing of any remaining controlled drugs safely.

In conclusion, conducting a clinical trial involving controlled drugs requires strict adherence to local laws and regulations, a robust protocol, secure supply chain, appropriate staff training, monitoring adverse events, implementing a double-check system, accurate record-keeping, appropriate blinding and randomization, patient confidentiality, and a clear plan for the end of the trial. Following these ten points can help ensure that the trial is conducted safely, ethically, and effectively, and that the results are valid and reliable.

GTC CONSULTING, based out of Cincinnati, Ohio is a leading consultancy that provides superior quality and regulatory support services to the pharmaceutical industry. These support service include: NABP Drug Distributor Accreditation (formerly VAWD) assistance, DEA Compliance consultation, Licensing/Registration support, Opioid Litigation support, Proper & Safe Drug Disposal support, and Drug Diversion Investigation & Prevention guidance. For more information contact us by email at info@gtcconsults.com or via phone at (513) 815-8779.