How to Find DND Clinical Trials

The Definitive Guide to Finding DND Clinical Trials: A Practical Roadmap for Patients and Advocates

Navigating the landscape of clinical trials, particularly for neglected diseases (DND), can feel like searching for a needle in a haystack. These diseases, often overlooked by mainstream pharmaceutical research due to lack of profitability, present unique challenges for patients seeking innovative treatments. However, organizations like the Drugs for Neglected Diseases initiative (DNDi) are dedicated to bridging this gap, developing life-saving therapies where market incentives fall short. This comprehensive guide provides a clear, actionable roadmap for individuals and their advocates to effectively identify and access DND clinical trials, cutting through the complexity to deliver practical steps.

Understanding DND Clinical Trials: What Makes Them Unique

Before diving into the “how-to,” it’s crucial to grasp the distinct nature of DND clinical trials. Unlike trials for common conditions, DND trials often:

• Focus on endemic regions: Many neglected diseases are prevalent in low- and middle-income countries, meaning trials may be concentrated in these areas. This can impact travel and logistical considerations for participants from other regions.

• Prioritize affordability and accessibility: DNDi and similar organizations are driven by a mission to develop treatments that are not only effective but also affordable and accessible to the affected populations. This influences drug development strategies and trial design.

• Address a range of diseases: DND trials cover a broad spectrum of conditions, including but not limited to, sleeping sickness (Human African Trypanosomiasis), Chagas disease, leishmaniasis, mycetoma, dengue, pediatric HIV, and cryptococcal meningitis.

• Emphasize collaborative models: These trials often involve extensive partnerships between research institutions, governments, healthcare providers, and local communities, reflecting a “patient-needs-driven” approach.

Understanding these characteristics will better equip you to tailor your search strategy and manage expectations.

Step 1: Laying the Groundwork – Initial Research and Medical Consultation

Effective trial searching begins with thorough preparation and a candid discussion with your healthcare provider. This foundational step ensures you’re looking for the right opportunities and are medically suitable for participation.

1.1 Pinpoint Your Specific Condition and Disease Characteristics

While you may know you have a “neglected disease,” precision is key. Research the exact name, sub-types, and specific characteristics of your condition. For example, “leishmaniasis” has several forms (cutaneous, visceral, mucocutaneous), each potentially having different treatment approaches and thus different trial criteria.

Concrete Example: If you have Chagas disease, determine if it’s in the acute or chronic phase, and if there are specific organ involvements (e.g., cardiac, digestive). This level of detail will be critical for filtering trial listings.

1.2 Consult Your Healthcare Provider

Your doctor is your most vital ally. They possess an in-depth understanding of your medical history, current health status, and the progression of your disease.

• Discuss your interest: Inform your doctor about your desire to explore clinical trial options.

• Assess eligibility: Your doctor can help you understand the general eligibility criteria for trials related to your condition, such as specific diagnostic markers, disease stage, previous treatments, and overall health. They can identify any contraindications or risks.

• Obtain medical records: Many trials require comprehensive medical records. Have these readily available or know how to access them quickly.

• Ask about existing knowledge: Your doctor may already be aware of ongoing trials, especially if they are involved in research or are part of a specialized treatment center.

Concrete Example: “Dr. Lee, I’ve been researching clinical trials for visceral leishmaniasis, and I’m interested in exploring this option. Based on my medical history and current condition, do you think I might be a candidate for any ongoing studies? Could you help me gather the necessary medical documentation, and perhaps suggest any specific research centers or networks that focus on this disease?”

Step 2: Navigating Primary Clinical Trial Registries

The most direct route to finding DND clinical trials is through established global and national clinical trial registries. These databases serve as central repositories for study information.

2.1 ClinicalTrials.gov: The Global Hub

ClinicalTrials.gov, maintained by the U.S. National Library of Medicine, is the largest and most comprehensive database of clinical studies worldwide. While it’s a U.S. government resource, it lists studies conducted globally, including many for neglected diseases.

Actionable Steps:

1. Access the Website: Go to ClinicalTrials.gov.

2. Basic Search:

   • Condition or disease: Start by typing in your specific condition (e.g., “Chagas disease,” “sleeping sickness,” “leishmaniasis,” “dengue”).

   • Other terms: Use this field to refine your search. For DND trials, you might try adding “DNDi” or “Drugs for Neglected Diseases initiative” to see studies sponsored or supported by them.

   • Intervention/Treatment: If you know a specific drug or type of intervention (e.g., “fexinidazole”), include it here.

3. Location: Many DND trials are conducted in disease-endemic areas.

   • Geographic Focus: If you’re willing to travel, broaden your location search to countries where the disease is prevalent (e.g., “Brazil” for Chagas, “Democratic Republic of Congo” for sleeping sickness, “India” for visceral leishmaniasis).

   • “Current location” and Radius: While less likely for DND trials unless you are in an endemic country with research infrastructure, you can use these if applicable.

4. Study Status: Filter for studies that are “Recruiting” or “Not yet recruiting” to find currently enrolling or soon-to-be enrolling trials. “Active, not recruiting” means the study is ongoing but not accepting new participants.

5. More Filters (Advanced Search):

   • Sponsor/Collaborator: Crucially, here you can explicitly search for “Drugs for Neglected Diseases initiative” or “DNDi” as a sponsor or collaborator. This will narrow your results significantly to trials directly supported by them.

   • Study Phase: For DND, you might consider Phase 2 or Phase 3 trials, as these are typically testing for efficacy in patients. Phase 1 trials are usually for safety in healthy volunteers or a small group of patients.

   • Age: Specify your age group if relevant.

   • Gender: Filter by gender if the condition or trial has gender-specific criteria.

Concrete Example: To find trials for sleeping sickness:

• Go to ClinicalTrials.gov.

• In “Condition or disease,” type “Human African Trypanosomiasis” or “sleeping sickness.”

• In “Other terms,” type “DNDi.”

• In “Study Status,” select “Recruiting” and “Not yet recruiting.”

• Click “Search.” Review the results. If too broad, use “More Filters” and under “Sponsor/Collaborator,” specifically add “Drugs for Neglected Diseases initiative.”

2.2 WHO International Clinical Trials Registry Platform (ICTRP)

The WHO ICTRP acts as a central search portal for clinical trial information from various primary registries worldwide, including ClinicalTrials.gov and many others specific to particular regions or diseases. This can be a good starting point if you want to cast a wider net.

Actionable Steps:

1. Access the Portal: Visit the WHO ICTRP website.

2. Search Fields: Similar to ClinicalTrials.gov, use keywords for your condition and any known interventions.

3. Registry Inclusion: Be aware that results will pull from multiple registries, which might require navigating to external sites for full details. This can be beneficial for discovering trials not immediately prominent on ClinicalTrials.gov.

Concrete Example: Searching for dengue trials:

• Go to the WHO ICTRP.

• Enter “Dengue” in the condition/disease field.

• Review the results, noting which primary registry each trial belongs to (e.g., ClinicalTrials.gov, ISRCTN, ANZCTR). Click through to the original registry for detailed information.

Step 3: Direct Engagement with DNDi and Partner Organizations

Beyond general registries, direct engagement with DNDi and its network of partners offers a more targeted approach. These organizations are at the forefront of DND research and development.

3.1 Explore the DNDi Website

The Drugs for Neglected Diseases initiative (DNDi) website is an invaluable resource. They often list their ongoing clinical trials, research priorities, and partnerships.

Actionable Steps:

1. Visit DNDi’s Official Website: Navigate to dndi.org.

2. Locate “Our Research” or “Clinical Trials” Section: Look for sections explicitly detailing their research pipeline, project portfolio, and current clinical studies.

3. Review Disease-Specific Information: DNDi categorizes its work by disease (e.g., Chagas, Leishmaniasis, HAT, Dengue). Explore the pages dedicated to your condition. These pages often highlight ongoing trials, recently completed studies, and future directions.

4. Check “Clinical Trial Protocol Synopses”: DNDi provides synopses of their clinical trial protocols, which can offer detailed insights into the trial’s design, objectives, and inclusion/exclusion criteria. This is often found under “Research & Development” -> “Clinical Trials.”

5. Look for Partner Information: DNDi often collaborates with local research institutions, hospitals, and public health programs in endemic countries. Their website may list these partners. Contacting these partners directly might yield information on local recruitment efforts.

Concrete Example: If you are interested in a new treatment for Chagas disease:

• Go to dndi.org.

• Navigate to “Our Research” -> “Chagas Disease.”

• Look for updates on current clinical trials, such as the one mentioned in news releases about AN2 Therapeutics’ collaboration on a Chagas disease compound.

• Check the “Clinical Trial Protocol Synopses” page for detailed information on trials like “Efficacy and safety of shorter benznidazole regimens and E1224 for chronic Chagas disease.” This synopsis would provide inclusion/exclusion criteria.

3.2 Vivli Platform for Data Sharing

DNDi shares its clinical trial data through platforms like Vivli. While Vivli is primarily for researchers requesting data, it also lists available studies. You might find information about ongoing or completed trials there, which can then guide your search to the original trial sites or DNDi directly for participation inquiries.

Actionable Steps:

1. Visit Vivli’s Website: Go to vivli.org.

2. Search for DNDi: Look for DNDi as a member or data contributor.

3. Browse DNDi Studies: While this platform isn’t for patient enrollment, it can confirm specific trials DNDi has conducted or is conducting, providing names and identifiers that you can then use in ClinicalTrials.gov or direct inquiries to DNDi.

Concrete Example: If you saw a DNDi study mentioned in an article, but can’t find details elsewhere, search for it on Vivli. If it’s listed, note its NCT number or DNDi study ID and use that on ClinicalTrials.gov for more patient-centric information.

Step 4: Connecting with Disease-Specific Patient Advocacy Groups and Networks

Patient advocacy groups and disease-specific networks are invaluable resources. They often have direct lines of communication with researchers, clinical trial sites, and may even maintain their own lists of ongoing studies.

4.1 Search for Patient Organizations

Identify and connect with organizations dedicated to your specific neglected disease. Many DNDs have international and regional patient advocacy groups.

Actionable Steps:

1. Online Search: Use search terms like “[Disease Name] patient advocacy group,” “[Disease Name] foundation,” or “[Disease Name] support network.”

2. Review Websites: Explore their “Research,” “Clinical Trials,” or “Get Involved” sections. These often feature information tailored for patients.

3. Contact Them Directly: Many organizations offer direct patient support. Reach out via email or phone to inquire about clinical trial opportunities. They might have internal lists, newsletters, or direct contacts with principal investigators.

Concrete Example: For Leishmaniasis, you might search for “Leishmaniasis patient support” or “Cutaneous Leishmaniasis research foundation.” Upon finding an organization, check their website’s “Clinical Trials” page or reach out to their patient navigator if they offer such a service.

4.2 Engage with DNDi’s Research Platforms and Networks

DNDi has established disease-specific research platforms and networks (e.g., Chagas Platform, HAT Platform, LEAP Platform for Leishmaniasis). These networks involve researchers and clinicians in endemic areas.

Actionable Steps:

1. Identify Relevant Platforms: On the DNDi website, learn about the platforms associated with your disease.

2. Explore Partner Institutions: Within these platforms, DNDi works with numerous research institutions and hospitals. Look for lists of these partners.

3. Direct Contact with Partner Sites: If a specific institution is listed in a country accessible to you, consider reaching out to their clinical research department or the relevant specialist. While they may not directly enroll patients via unsolicited emails, they can guide you on local recruitment processes.

Concrete Example: If you are interested in a clinical trial for sleeping sickness, you would investigate the “HAT Platform” on DNDi’s website. You might find a list of partner hospitals or research centers in the Democratic Republic of Congo or Uganda. You could then research those specific institutions’ websites for contact information regarding their clinical trial units.

Step 5: Leveraging Academic and Research Institutions

Major universities and research centers, especially those with strong public health or infectious disease departments, are often involved in DND research and clinical trials.

5.1 Identify Key Research Institutions

Look for institutions known for their work in neglected tropical diseases or global health. These are often located in countries with high disease burdens or in developed nations with strong research funding.

Actionable Steps:

1. University Websites: Search the websites of prominent universities and research institutes (e.g., London School of Hygiene & Tropical Medicine, Institute Pasteur, Oswaldo Cruz Foundation in Brazil, Kenyan Medical Research Institute). Look for their “Research,” “Departments,” or “Clinical Trials” sections.

2. Faculty Profiles: Identify researchers specializing in your specific disease. Their faculty profiles often list their current projects, publications, and any ongoing clinical trials they lead.

Concrete Example: If you have Mycetoma, you might research institutions in Sudan, where DNDi has conducted trials. Search for academic medical centers in Khartoum and look for departments of tropical medicine or infectious diseases. Their websites may have a “Clinical Research” or “Trials” section.

5.2 Reach Out to Clinical Research Coordinators

Once you identify a promising trial or research group, look for contact information for their clinical research coordinator (CRC) or study team. CRCs are often the first point of contact for potential participants.

Actionable Steps:

1. Craft a Concise Email: Introduce yourself, briefly state your condition and interest in their research, and ask if they have any active recruiting trials for which you might be eligible. Attach a brief summary of your medical history if appropriate, but avoid sending extensive records initially.

2. Be Prepared for Screening Questions: The study team will likely ask preliminary questions to determine basic eligibility before inviting you for a full screening.

Concrete Example: “Dear [Clinical Research Coordinator Name], My name is [Your Name], and I have [Your Condition, e.g., visceral leishmaniasis]. I am writing to inquire about potential participation in clinical trials related to [Your Condition] at your institution. I saw [mention specific research or trial if you found it, e.g., ‘your work on LXE408 for VL’]. Would you be able to provide information on any currently recruiting studies for which I might be eligible? I can provide a summary of my medical history upon request.”

Step 6: Understanding Eligibility Criteria and the Informed Consent Process

Once you identify a potential trial, the real work of evaluating suitability begins.

6.1 Deciphering Eligibility Criteria

Every clinical trial has strict inclusion and exclusion criteria. These are designed to ensure patient safety and the integrity of the study results.

• Inclusion Criteria: These are the characteristics a volunteer must possess to be eligible for the trial (e.g., confirmed diagnosis of a specific disease subtype, within a certain age range, specific lab values).

• Exclusion Criteria: These are the characteristics that prevent a volunteer from participating (e.g., certain co-existing medical conditions, previous treatments that might interfere with the study drug, pregnancy).

Actionable Steps:

1. Read Carefully: When viewing a trial listing on ClinicalTrials.gov or a DNDi synopsis, pay meticulous attention to the “Eligibility” section.

2. Cross-Reference with Your Medical Records: Go through each criterion and compare it to your own medical history and current health status.

3. Clarify with Your Doctor: If any criterion is unclear, or if you’re unsure how your specific medical situation aligns, discuss it with your doctor. They can help interpret medical jargon and assess your fit.

Concrete Example: A trial for Chagas disease might list “Inclusion Criteria: Confirmed Trypanosoma cruzi infection by two distinct serological methods; chronic indeterminate form.” And “Exclusion Criteria: Prior treatment with benznidazole in the last 6 months; severe cardiac complications (NYHA Class III/IV).” You would need to ensure your diagnostic tests match, that your disease is in the specified stage, and that you haven’t recently received the excluded medication or have advanced heart failure.

6.2 The Informed Consent Process

If you appear to meet the initial eligibility criteria, you will be invited to discuss the trial in detail and undergo the informed consent process.

• What it entails: You will receive a detailed document (the informed consent form, or ICF) explaining the study’s purpose, procedures, potential risks and benefits, alternatives, and your rights as a participant.

• Your rights: You have the right to ask questions, take time to consider your decision, and withdraw from the study at any time without penalty.

• No guarantees: Clinical trials involve investigational treatments, and there’s no guarantee of benefit. You may receive the active drug, a placebo, or a standard treatment depending on the trial design.

Actionable Steps:

1. Read Thoroughly: Do not sign anything until you fully understand every aspect of the trial.

2. Ask Questions: Prepare a list of questions beforehand. Ask about:

   • The purpose of the trial.

   • What treatments are involved (and if there’s a placebo arm).

   • The duration and frequency of visits.

   • All potential side effects and risks.

   • Who will cover medical costs related to the trial.

   • What happens after the trial concludes (e.g., continued access to the drug).

   • Contact information for the study team and an independent ethics committee.

3. Bring a Trusted Person: Consider bringing a family member or close friend to help you understand the information and ask questions.

4. Discuss with Your Doctor: Review the ICF with your primary healthcare provider before making a decision.

Concrete Example: During the informed consent discussion for a new Dengue treatment, you might ask: “Will I definitely receive the new drug, or is there a chance I’ll get a placebo? What are the most common side effects observed in early studies? If the trial drug works for me, will I be able to continue receiving it after the study ends?”

Step 7: Overcoming Challenges and Maintaining Persistence

Finding DND clinical trials can be challenging due to various factors, including the rarity of some diseases, geographical limitations, and specific eligibility requirements. Persistence is key.

7.1 Geographical Considerations

Many DND trials are conducted in the regions where these diseases are endemic, often in low-resource settings. This can pose logistical and financial challenges for participants from other areas.

Actionable Strategy:

• Be Realistic: Understand that relocation or significant travel may be necessary.

• Inquire about Support: Some trials, particularly those funded by non-profit organizations, may offer some support for travel or accommodation, but this is not guaranteed. Always inquire about what, if any, logistical support is provided.

• Explore Telemedicine/Local Partners: In some cases, trials might have satellite sites or integrate telemedicine components, but this is less common for DND trials requiring intensive monitoring. Inquire if any local healthcare providers can facilitate participation without extensive travel.

Concrete Example: If a DNDi trial for Visceral Leishmaniasis is only recruiting in Ethiopia and India, and you live in Europe, you need to factor in the costs and logistics of international travel and extended stays. You would ask the study coordinator if there are any provisions for international participants.

7.2 The “Do Not Dispense” (DND) Misconception

It’s important to clarify that when searching for “DND clinical trials,” you are looking for trials related to Neglected Diseases, often those led or supported by the Drugs for Neglected Diseases initiative (DNDi). The term “DND” in a clinical trial context can also refer to “Do Not Dispense” dates for drug kits, which is an internal operational parameter for trial logistics and irrelevant to patient search. Ensure your search terms are focused on the disease area or organization.

Actionable Strategy:

• Refine Search Terms: Always use “DNDi,” “Drugs for Neglected Diseases initiative,” or the full disease name (e.g., “Chagas disease clinical trial”) to avoid confusion.

7.3 Patient Screening and Recruitment Bottlenecks

Even if a trial is recruiting, patient enrollment can be a lengthy process due to rigorous screening and limited slots.

Actionable Strategy:

• Be Patient: The process from initial inquiry to enrollment can take weeks or months.

• Maintain Communication: Follow up politely with study teams if you haven’t heard back within a reasonable timeframe.

• Don’t Give Up After One Trial: If you’re not eligible for one trial, continue searching for others. Eligibility criteria vary significantly.

Concrete Example: After an initial phone screening for a trial, you might be told they will review your records and get back to you in two weeks. If you don’t hear back, a polite email after three weeks checking on the status of your application is appropriate.

Conclusion

Finding a DND clinical trial requires a proactive, informed, and persistent approach. By understanding the unique landscape of neglected diseases research, strategically utilizing major registries and organizational websites, engaging with patient advocacy groups, and preparing for the stringent eligibility and consent processes, patients and their advocates can significantly increase their chances of accessing these vital, often life-changing, opportunities. Remember, your healthcare provider is your primary guide in this journey, and clear communication with research teams is paramount. The fight against neglected diseases is ongoing, and your participation in clinical trials can contribute not only to your own well-being but also to the development of treatments for millions worldwide.